Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006161756

FEI Number

3002808127

Entity Name

FUJIFILM Healthcare Manufacturing Corporation Sano Office

City/State/Country

Sano City Tochigi, JP

Establishment Address

700 Konaka-Cho, Sano City Tochigi 327-0001, JP

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

FUJIFILM CORPORATION (Owner Number: 8031568)

Owner / Operator Contact Address

26-30, Nishiazabu 2-chome, MINATO-KU, JP-13 106-8620, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

FUJIFILM Processor EP-8000 FUJIFILM Endoscope Model EG-860R Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter) Endoscopic Ultrasonic Probe P2620S-L / P2612S-L MPC-P Mouth Piece MPC-ST Mouth Piece Fujifilm Diathermic Slitter (FlushKnife) Endoscope Model EI-740D/S EC-740T/L Colonoscope EG-760CT Gastroscope EC-760P-V/L Colonoscope Double Balloon Endoscope EN-840T CA-616 Cleaning Adapter FV--003 Forceps Valve SB-606 Suction Valve EB-710P Bronchoscope FUJIFILM Ultrasonic Processors SU-1 PLATINUM and SU-1 FUJIFILM Endoscope Model EG-840T FUJIFILM Endoscope Model EG-840TP FUJIFILM Endoscope Model EG-840N Color Balance Tool CB-01P, CB-01B Video Colonoscope EC-760R-V/L Video Colonoscope EC-760ZP-V/L Video Gastroscope EG-760R Video Gastroscope EG-760Z Water Tank WT-603 ED-580XT Duodenoscope BS-102 UC-01 EG-740UT B20BU Balloon for EB-530US FOV-BU1 Forceps Valve for EB-530US CA-500B Cleaning Adapter Kit for G-5 Bronchoscopes CA-500C Cleaning Adapter Kit CA-500BU Cleaning Adapter Kit for EB-530US DC-07D Distal End Cap ED-580XT Duodenoscope FUJIFILM Endoscope Model EG-840T FUJIFILM Endoscope Model EG-840TP FUJIFILM Endoscope Model EG-840N Fujifilm Tubing, Model TY-06D Fujifilm Overtube, TS-13140 Fujifilm Tubing, Model TY-04D Fujifilm Enteroscope EN-580T FUJIFILM Hood Model DH-29CR FUJIFILM Hood Model DH-30CR FUJIFILM Hood Model DH-28GR KE-007D LT-7F LEAKAGE TESTER AW-603 Air/Water Valve SB-604 Suction Valve LMP-001 LAMP ASSEMBLY FOR EPX-2200 LMP-002 LAMP ASSEMBLY FOR EPX-4400/4400HD FV-001 Forceps Valve FOV-LL2 Forceps Valve for EG-530UT2 CA-617 Cleaning Adapter FV-003 Forceps Valve CA-614 Cleaning Adapter ST-05B Single Use Balloon Applicator for DBE BA-BU1 Balloon Attachment Tool for EB-530US AW-602 Air/Water Valve BA-03 Balloon Attachment Tool WA-7000 US Waterproof Cap FV-002 Forceps Valve CC7-301 Cable FOV-DV7 Disposable Forceps Valve Cover for G-5 Endoscopes ST-01B Black Band Applicator for DBE CA-608 Cleaning Adapter BA-1 Balloon Attachment Tool for EG-530UT2 CA-610 Cleaning Adapter AW-500 A-W BUTTON FOR G-5 SCOPES CA-606 Balloon Channel Cleaning Adapter for EN-580T CA-601 Cleaning Adapter Kit for EG-530UR2/UT2 CA-503/A Cleaning Adapter Kit for G-5 Endoscopes ST-10 Setting Tool CA-611 Air/Water Channel Cleaning Adapter CA-510/A Cleaning Adapter Kit /530 Series Endoscopes CA-503B/C Forceps Inlet Cleaning Adapter for G-5 Endoscopes AW-601 Air/Water Button for Ultrasonic Endoscope CA-609 Air/Water Channel Cleaning Adapter SB-605 Suction Valve SB-500 Suction Button for G-5 Scopes SB-601 Suction Button for Ultrasonic Endoscope EB-530H Bronchoscope SB-602 Suction Button for 530 Series Bronchoscopes (Sterile) Endoscope Model EC-760S-V/L EB-710XT Endoscope Model EI-740D/S Ultrasonic Endoscope EB-530US Ultrasonic Endoscope EG-580UR Ultrasonic Endoscope EG-580UT FUJIFILM Ultrasonic Endoscope EB-710U VS-1000 EG-S100XT Over-Tube TS-1314B Tube Kit TY-500D Scope Balloon BS-4 Endoscope Model EN-580T TR-1108A EN-580T DH-094STR DH-114STR DH-084STR DH-124STR DH-104STR DH-134STR Endoscope Model EG-740N EB-530H Bronchoscope Video Bronchoscope EB-530P FUJIFILM Ultrasonic Processors SU-1 PLATINUM and SU-1 Distal Cap Model DH-17EN2 Distal Cap Model DH-32EN Balloon BS-3 FUJIFILM Over-tube TR-1504A FUJIFILM Over-tube TR-1507A B20UT Balloon for EG-530UT Series Ultrasonic Endoscopes B20UR Balloon for EG-530UR Series Ultrasonic Endoscopes CA-601 Cleaning Adapter Kit for Ultrasonic Endoscope EB-840S EB-840T EB-580S Bronchoscope EB-580T Bronchoscope DK2623JI FUJIFILM Diathermic Slitter (FlushKnife) DK2620JI FUJIFILM Diathermic Slitter (FlushKnife) TS-12140 Sterile Overtube TS-13101 Sterile Overtube TS-13140 Sterile Overtube JT-500 J-Tube Ultrasonic Probe PB2020-M2 Ultrasonic Processor SP-900 CP-1TB Trackball Keyboard for Ultrasonic Processors CP-1 Touch-pad Keyboard for Ultrasonic Processors Data Keyboard DK-7000E for VP-7000 and BL-7000 System FS1 Foot Switch for EPX-4440HD

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2025-04-24
NTN	Led Light Source	Gastroenterology, Urology	Class 2	876.1500	2025-04-24
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2025-04-24
PEA	Endoscope, Accessories, Image Post-Processing For Color Enhancement	Gastroenterology, Urology	Class 2	876.1500	2025-04-24
NWB	Endoscope, Accessories, Narrow Band Spectrum	Gastroenterology, Urology	Class 2	876.1500	2025-04-24
KGE	Forceps, Biopsy, Electric	Gastroenterology, Urology	Class 2	876.4300	2017-11-09
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2023-12-18
MNK	Endoscopic Bite Block	Gastroenterology, Urology	Class 1	876.1500	2013-03-20
KGE	Forceps, Biopsy, Electric	Gastroenterology, Urology	Class 2	876.4300	2017-11-09
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2021-04-12
FAM	Sigmoidoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2021-04-12
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2019-07-16
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2019-07-16
FDA	Enteroscope And Accessories	Gastroenterology, Urology	Class 2	876.1500	2024-06-18
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2022-11-23
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2020-07-06
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2020-07-06
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2020-07-06
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2020-07-06
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2025-06-11
NWV	Laparoscopic Accessories, Gynecologic	Obstetrics/Gynecology	Class 1	884.1720	2024-08-12
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2018-03-09
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2018-03-09
FDT	Duodenoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2019-11-13
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2022-08-19
ODG	Endoscopic Ultrasound System, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2022-08-19
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2022-08-19
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2012-06-18
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2012-06-18
FCL	Forceps, Biopsy, Non-Electric	Gastroenterology, Urology	Class 1	876.1075	2008-10-02
FDT	Duodenoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2019-03-29
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2024-09-06
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2015-09-08
FDA	Enteroscope And Accessories	Gastroenterology, Urology	Class 2	876.1500	2015-09-08
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2017-06-21
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2017-06-21
FFY	Adaptor, Bulbs, Miscellaneous, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2013-03-07
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2013-03-05
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2019-05-07
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2024-02-09
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2023-01-30
FAM	Sigmoidoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2023-01-30
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2019-02-25
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2019-02-25
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2022-08-04
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2022-08-04
ODG	Endoscopic Ultrasound System, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2022-08-04
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2025-12-18
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2026-02-19
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2026-02-19
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2023-01-11
FDA	Enteroscope And Accessories	Gastroenterology, Urology	Class 2	876.1500	2023-01-11
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2024-11-27
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2019-03-11
FDA	Enteroscope And Accessories	Gastroenterology, Urology	Class 2	876.1500	2019-03-11
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2026-02-09
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2026-02-09
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2019-04-02
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2019-04-04
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2018-01-31
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2016-04-21
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2021-08-19
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2021-08-19
FDA	Enteroscope And Accessories	Gastroenterology, Urology	Class 2	876.1500	2021-10-29
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2023-09-16
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2013-03-19
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2013-03-19
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2026-06-18
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2019-08-23
KGE	Forceps, Biopsy, Electric	Gastroenterology, Urology	Class 2	876.4300	2022-02-04
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2013-03-19
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2013-03-19
ODG	Endoscopic Ultrasound System, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2022-06-03
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2022-06-03
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2022-06-03
FEM	Accessories, Photographic, For Endoscope (Exclude Light Sources)	Gastroenterology, Urology	Class 1	876.1500	2015-12-21

Official Correspondent

No official correspondent registered.

US Agent Details

Randy Vader Business: FUJIFILM Healthcare Americas Corporation Email: randy.vader@fujifilm.com Phone: (360) 3566821

Related Public Records

Same Entity

FUJIFILM CORPORATION

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3020707080	FUJIFILM medwork GmbH	Hochstadt/Aisch Bavaria, DE
3008787461	FUJIFILM Imaging System (Suzhou) Co., Ltd.	Suzhou Jiangsu, CN
2155	FUJIFILM Healthcare Manufacturing Corporation Minamiashigara Takematsu Office	MINAMIASHIGARA-SHI Kanagawa, JP
3005625991	FUJIFILM Healthcare Americas Corporation	Edison, NJ, US
3034364687	FUJIFILM Corporation Material Manufacturing Headquarters	Fujinomiya Shizuoka, JP

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K232314	FUJIFILM Healthcare Americas Corporation	Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)	2023-09-01
K951723	GE Medical Systems	GE B510 TRANSDUCER	1995-11-14
K903562	Diasonics, Inc.	CW DOPPLER 2.25 MHZ PROBE	1992-03-02
K945318	Tetra Corp.	TETRAD MODEL 6F, END-VIEWING, ENDOCAVITY PROBE, 4.5/8.5 MHZ, CA	1995-05-05
K231666	FUJIFILM Healthcare Americas Corporation	Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)	2023-12-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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:
Z-0029-2022	Aesthetics Systems Usa Inc	2	Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue.
Z-0038-2026	ImaCor Inc.	2	ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH.
Z-0025-2020	AURIS HEALTH INC	2	Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006161756. Last updated year: 2026. Please use registration number 3006161756 when referencing this establishment in official correspondence.