Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007738736

FEI Number

3007738736

Entity Name

Synergy Health AST, SRL

City/State/Country

Alajuela, CR

Establishment Address

B16 Street 4, Avenue 0, Coyol Free Zone, Alajuela 20102, CR

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

Synergy Health AST, LLC (Owner Number: 10028672)

Owner / Operator Contact Address

5960 Heisley Road, Mentor, OH 44060, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Arthocare8208 (CR1) - REFLEX ULTRA PTR with Integrated Cable Arthocare8208 (CR1) - PROCISE XP Wand with Integrated Cable (MULS) Arthocare8208 (CR1) - TURBINATOR Wand (MULS) Arthocare8208 (CR1) - EXCISE PDW Wand with Integrated Cable Arthocare8208 (CR1) - REFLEX ULTRA 55 with Integrated Cable Arthocare8208 (CR1) - EVAC 70 HP with Integrated Cable Arthocare8208 (CR1) - PROCISE LW Wand with Integrated Cable Arthocare8208 (CR1) - EVAC 70 Xtra with Integrated Cable Arthocare8208 (CR1) - REFLEX ULTRA 45 with Integrated Cable (MULS) Arthocare8208 (CR1) - PROCISE XP Wand with Integrated Cable Arthocare8208 (CR1) - REFLEX ULTRA SP with Integrated Cable (MULS) Arthocare8208 (CR1) - PROCISE EZ-View with Integrated Cable Arthocare8208 (CR1) - REFLEX ULTRA SP with Integrated Cable Arthocare8208 (CR1) - TURBINATOR Wand Arthocare8208 (CR1) - PROCISE MLW Wand with Integrated Cable Arthocare8208 (CR1) - PROCISE EZ Wand with Integrated Cable Arthocare8208 (CR1) - PROCISE MLW Wand with Integrated Cable (MULS) Arthocare8208 (CR1) - REFLEX ULTRA 45 with Integrated Cable Arthocare8208 (CR1) - PROCISE LW Wand with Integrated Cable (MULS) Arthocare8208 (CR1) - PROCISE MAX with Integrated Cable Arthocare8208 (CR1) - REFLEX ULTRA PTR with Integrated Cable (MULS) Arthocare8208 (CR1) - EVAC 70 HP with Integrated Cable (MULS) Arthocare8208 (CR1) - EVAC 70 Xtra with Integrated Cable (MULS) Arthocare8208 (CR1) - PROCISE EZ Wand with Integrated Cable (MULS) Arthocare8208 (CR1) - REFLEX ULTRA 55 with Integrated Cable (MULS) Arthocare8208 (CR1) - PROCISE MAX with Integrated Cable (MULS) Arthocare8208 (CR1) - PROCISE EZ-View with Integrated Cable (MULS) AbbottVasc (CR1) - HT Whisper LS AbbottVasc (CR1) - HT Whisper ES Establishment9150 (CR1) - Motiva Inflatable Balloon AbbottVasc (CR1) - HT WINN AbbottVasc (CR1) - HT Balance Colplast1941 (CR1) - SpeediCath Flex Coude Pro AbbottVasc (CR1) - HT Command Shockwave7578 (PT,SDB*) - Shockwave C2 Coronary IVL Catheters Shockwave7578 (PT,SDB*) - Shockwave C2+ Coronary Intravascular Lithotripsy (IVL) Catheter Shockwave7578 (CR1) - Intravascular Lithotripsy (IVL) System with the Shockwave C2 Aero Coronary IVL Catheter Shockwave7578 (CR1,PT) - Shockwave M5+ Peripheral Intravascular Lithotripsy (IVL) Catheter Colplast1941 (CR1) - SpeediCath Standard AbbottVasc (CR1) - ARMADA 35 Arthocare8208 (CR1) - CAP-FIXCAP-FIX SUTURE PASSER 70 DEG Arthocare8208 (CR1) - CAP-FIX SUTURE PASSER 45 DEG Arthocare8208 (CR2) - ACCU-PASS DIRECT Suture Passer, Crescent XL Toby7429 (PT) - PASSER, RETRACTOR Acclarent8881 (CR2) - RELIEVA ULTIRRA NAV Sinus Balloon Catheter Arthocare8208 (CR1) - Topaz EZ IFS Acclarent8881 (CR2) - TruDi Curette AbbottVasc (CR1) - HT Balance Middleweight Arthocare8208 (CR1) - AMBIENT HIPVAC 50 IFS Arthocare8208 (CR1) - Super MULTIVAC 50 IFS 3.75mm 50 Suction Arthocare8208 (CR1) - AMBIENT Super MULTIVAC 50 3.75mm 50 Suction IFS Arthocare8208 (CR2) - FAST-FIX 360 STRAIGHT KNOT PUSHER/CUTTER AND SLOTTED CANNULA SETS Arthocare8208 (CR2) - FIRSTPASS ST Suture Passer Self-Capture Arthocare8208 (CR2) - FIRSTPASS Mini Suture Passer, Arthocare8208 (CR2) - FIRSTPASS Mini Suture Passer, Straight Arthocare8208 (CR2) - FIRSTPASS ST Suture Passer Standar Arthocare8208 (CR2) - ULTRA FAST-FIX KNOT PUSHER/SUTURE CUTTER STRAIGHT Arthocare8208 (CR2) - CLEAR TRAC COMPLETE HIP CANNULA 8.5X90 Arthocare8208 (CR2) - FAST-FIX 360 CURVED KNOT PUSHER/CUTTER AND SLOTTED CANNULA SETS Arthocare8208 (CR1) - FIRSTPASS Needle and Suture Capture Arthocare8208 (CR2) - FIRSTPASS Mini Suture Passer, Left Arthocare8208 (CR2) - CLEAR TRAC COMPLETE HIP CANNULA 7X110 Arthocare8208 (CR1) - CAP-FIX Blade, Straight, with Handle Arthocare8208 (CR2) - CLEAR TRAC COMPLETE HIP CANNULA 7X90 Arthocare8208 (CR2) - CLEAR TRAC COMPLETE HIP CANNULA 8.5X110 AbbottVasc (CR1) - HT Balance Heavyweight ICU7944 (CR1) - IV Administration

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-06-29
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2023-05-31
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2016-07-22
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2016-07-22
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2018-11-19
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2012-11-13
MQK	Labware, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6160	2012-11-13
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2021-10-25
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2021-10-25
PHC	Infusion Safety Management Software	General Hospital	Class 2	880.5725	2022-06-30
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2022-06-30
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2022-06-30
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2012-11-16
FZW	Expander, Surgical, Skin Graft	General, Plastic Surgery	Class 1	878.4800	2025-06-17
HXI	Passer, Wire, Orthopedic	Orthopedic	Class 1	888.4540	2018-12-21
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2016-06-06
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2023-11-08
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2023-11-08
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2019-01-14
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2018-11-19
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2018-11-19
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2016-06-06
HGP	Electrode, Circular (Spiral), Scalp And Applicator	Obstetrics/Gynecology	Class 2	884.2675	2012-11-13
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2018-11-19
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2018-12-02
FDI	Snare, Flexible	Gastroenterology, Urology	Class 2	876.4300	2018-06-21
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2018-06-21
GBM	Catheter, Urethral	Gastroenterology, Urology	Class 2	876.5130	2024-01-31
GBO	Catheter, Nephrostomy, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4200	2023-06-29
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2021-10-25
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2018-11-19
BYY	Tube, Aspirating, Flexible, Connecting	General Hospital	Class 2	880.6740	2019-01-14
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2016-06-06
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2022-09-28
QMG	Shockwave Intravascular Lithotripsy System	Unknown	Class 3	N/A	2021-02-25
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2012-11-16
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2012-11-16
PPN	Percutaneous Catheter, Ultrasound	Cardiovascular	Class 2	870.1250	2021-12-22
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2012-11-16
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2018-11-19
GBM	Catheter, Urethral	Gastroenterology, Urology	Class 2	876.5130	2022-11-29
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2018-12-02
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2018-12-02
NFA	Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection	Cardiovascular	Class 2	870.1250	2012-12-26
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2012-11-16
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2014-04-29
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2014-04-29
MRZ	Accessories, Pump, Infusion	General Hospital	Class 2	880.5725	2018-12-02
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2018-11-19
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2018-11-19
HWQ	Passer	Orthopedic	Class 1	888.4540	2012-11-15
KGE	Forceps, Biopsy, Electric	Gastroenterology, Urology	Class 2	876.4300	2012-10-31
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2021-10-25
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2019-05-16
NTE	Temporary Carotid Catheter For Embolic Capture	Cardiovascular	Class 2	870.1250	2012-12-26
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2014-12-31
QCA	Intracranial Coil-Assist Stent	Unknown	Class 3	N/A	2019-01-16
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2018-12-02
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2019-01-14
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2021-10-25
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2012-11-16
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2018-11-19
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2018-11-19
PGW	Ear, Nose, And Throat Stereotaxic Instrument	Neurology	Class 2	882.4560	2020-09-11
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2023-06-01
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2018-11-19
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2012-11-16
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2018-12-02
FCL	Forceps, Biopsy, Non-Electric	Gastroenterology, Urology	Class 1	876.1075	2012-11-15
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2026-06-05
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2018-11-19
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2012-11-16
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2012-11-16
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2012-11-16
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2025-05-12
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2025-05-12
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2018-11-19
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-06-29
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2018-06-21
DXK	Echocardiograph	Cardiovascular	Class 2	870.2330	2018-06-21
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2012-10-31
FMG	Stopcock, I.V. Set	General Hospital	Class 2	880.5440	2013-02-12
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2018-11-19
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2021-10-25
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2020-10-22
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2018-11-19
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2012-11-16
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2012-11-16
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2018-11-15
PHC	Infusion Safety Management Software	General Hospital	Class 2	880.5725	2022-07-29
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2022-07-29
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2022-07-29
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2012-11-16
MRZ	Accessories, Pump, Infusion	General Hospital	Class 2	880.5725	2018-12-02
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-02-28
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-06-29
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2014-12-31
MEA	Pump, Infusion, Pca	General Hospital	Class 2	880.5725	2022-09-28
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2022-09-28
BWH	Forceps, Biopsy, Bronchoscope (Non-Rigid)	Ear, Nose, Throat	Class 2	874.4680	2012-10-31
PPN	Percutaneous Catheter, Ultrasound	Cardiovascular	Class 2	870.1250	2020-02-06
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2014-07-24
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2018-11-19
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2012-11-16
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2012-11-16
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2018-11-19
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2023-05-31
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2012-11-16
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2018-11-15
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2018-12-02
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2018-11-19
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2018-11-19
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2018-11-19
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2018-07-23

Official Correspondent

No official correspondent registered.

US Agent Details

Becky Aldhizer Business: Synergy Health AST, LLC Email: Becky_Aldhizer@steris.com Phone: (440) 4687462

Related Public Records

Same Entity

Synergy Health AST, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3010421104	STERIS TOMOE SINGAPORE PTE LTD	Singapore South West, SG
3009882464	Synergy Health AST, LLC	Saxonburg, PA, US
3017636737	STERIS Corporation de Republica Dominicana, S.R.L.	Santo Domingo, DO
2030598	Synergy Health AST, LLC	SAN DIEGO, CA, US
3012102437	Synergy Health AST, LLC	Petaluma, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02
K192128	Sutter Medizintechnik GmbH	Sutter Arrowtip Monopolar Electrodes	2019-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0030-2009	Boston Scientific Corporation	2	Platinum Plus" LT , REF 46-601, UPN M001466010, LT/0.018/180, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
Z-0031-2009	Boston Scientific Corporation	2	Platinum Plus" LT , REF 46-602, UPN M001466020, LT/0.018/260, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
Z-0009-2022	DJO, LLC	2	GEL CONDUCTOR, Description/REF: 5 LITER W/DISP/4238, 24-8.5OZ BOTTLES/4248, 5 LITER/4266, distributed by DJO, LLC / DJO FRANCE in the following kits, Part/Description: 2073/ INTELECT RPW 120V, 2073-BR/ INTELECT RPW 120V BRAZIL, 2074/ INTELECT RPW 230 V, 2082/ INTELECT RPW 100 V, 2760/ INTELECT LEGEND XT COMBOUS STD, 2791/ INTELECT LEGEND XT COMBO US STD W/CART, 2782-10/ INTELECT TRANSPORT US STD, 2782-2/ INTELECT TRANSPORT US STD, 2843/ INTELECT VET 4CH COMBO PKG, 2845K/ KIT INTELECT VET 4CH COMBO PKG, 2863/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 5CM, 2863-10/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 10CM APPL, 2863-2/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 2CM APPL, 2864/ SENIOR SOLUTIONS 4CH COMBO PKG US STD, 2761/ VECTRA GENISYS 2CH COMBO PKG US STD 5CM APPL, 2792/ VECTRA GENISYS 2CH COMBO US STD W/CART, 2761-10/ VECTRA GENISYS 2CH COMBO PKG US STD 10CM APPL, 2761-2/ VECTRA GENISYS 2CH COMBO PKG US STD 2CM APPL, 2762CC/ INT ADV 2CH COLOR COMBO INT'L 5CM APPL, 2762CC-10/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 10CM APPL, 2762CC-2/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 2CM APPL, 2788/ LEGEND XT 4CH COMBO PKG US STD 5CM APPL, 2795/ INTELECT XT 4CH COMBO US STD 5CM APPL W/CART, 2788-10/ LEGEND XT 4CH COMBO PKG US STD 10CM APPL, 2795-10/ INTELECT XT4CH COMBO US STD 10CM APPL, 2788-2/ LEGEND XT 4CH COMBO PKG US STD 2CM APPL, 2795-2/ INTELECT XT 4CH COMBO US STD 2CM APPL, 2789/ VECTRA GENISYS 4CH COMBO PKG US 5CM APPL, 2796/ VECTRA GENISYS 4CH COMBO US STD W/CART, 2796K/ KIT VECTRA GENISYS 4CH COMBO P, 2789-10/ VECTRA GENISYS 4CH COMBO PKG US STD 10CM APPL, 2796-10/ VECTRA GENISYS 4CH COMBO US US STD 10CM APPL, 2789-2/ VECTRA GENISYS 4CH COMBO PKG US STD 2CM APPL, 2796-2/ VECTRA GENISYS 4CH COMBO US STD 2CM APPL, 2738/ INTELECT TRANSPORT COMBO PKG US STD, 8250KP/ KIT TRITON DTS PROMO, 6001/ INTELECT NEO, 2738-10/ INTELECT TRANSPORT COMBO PKG US STD, 2738-2/ INTELECT TRANSPORT COMBO PKG US STD, 2772MC/ INT ADVANCED COMBO MONOCHROMEINT'L STD, 2776/ INTELECT MOBILE INT'L STD 5CM APPL, 27800/ ULTRASOUND ON CART, 2776-BR/ INTELECT MOBILE INTL STD 5CM APPL BRAZIL, 2776-10/ INT MOBIL INT'L STD 10CM APPL, 2776-2/ INT MOBILE INT'L STD 2CM APPL, 2778/ INTELECT MOBILE COMBO INT'L STD 5CM APPL, 2778-10/ INTELECT MOBILE COMBO INT'L STD 10CM APPL, 2778-2/ INTELECT MOBILE COMBO INT'L STD 2CM APPL, 2752CC/ INT ADV 2CH COLOR COMBO INT'L STD, 2756/ INTELECT VET 2CH COMBO PKG INT'L STD, 2844K/ KIT INTELECT VET 2CH COMBO PKG, 2782/ INTELECT TRANSPORT US STD, 2895K/ KIT CART ADAPT BL W/CT/SPEC US, 2872/ VECTRA GEN 2C COMBO W/O EMG PK US STD, 2876/ VECTR GEN 2C COMBO W/O EMG US STD W/CART, 2874/ VECTRA GEN 4C COMBO W/O EMG PK US STD, 2878/ VECTR GEN 4C COMBO W/O EM US STD W/CART, 7550/ INT LEGEND COMBO 4C US STD, INT001/ INTELECT LEGEND ULTRASOUND US STD, INTC B/ INT CB PKGD US STD, 39-0701/ DIRECT SUPPLY PANACEA VECTRA 2-CHNL ULTRASOUND/ESTIM COMBO, 39-0702/ DIRECT SUPPLY PANACEA VECTRA 4-CHNL ULTRASOUND/ESTIM COMBO, 13-4248/ GEL CONDUCTOR 24-8.5OZ BOTTLES, 15-1200/ INTELECT MOBILE 2 ULTRASOUND INTL SET EU PLUG, 15-1201/ INTELECT MOBILE 2 ULTRASOUND INTL SET ALL PLUGS, 15-1204/ INTELECT MOBILE 2 COMBO INTL SET EU PLUG, 15-1205/ INTELECT MOBILE 2 COMBO INTL SET ALL PLUGS, 2173KIT/ INTELECT RPW 2 120V INTERNATIONAL KIT US PLUG, 2174KIT/ INTELECT RPW 2 230V KIT EU PLUG, 2175KIT/ INTELECT RPW 2 100V KIT JPN PLUG, 2176KIT/ INTELECT RPW 2 120V USA KIT, 12-2756-1/ INTELECT VET 2CH COMBO PKG INTL STD, 2756K/ KIT INTELECT VET 2CH COMBO PKGUS STD, 70002/ NEO MODULE ULTRASOUND
Z-0010-2022	DJO, LLC	2	Ultra-Myossage Lotion 1-gallon bottle, REF: 4262; Myossage Lotion 1-gallon bottle, REF: 4210, located in the following DJO, LLC / DJO FRANCE kits:

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007738736. Last updated year: 2026. Please use registration number 3007738736 when referencing this establishment in official correspondence.