PHARMASEPT LTD. MEDICAL PRODUCTS

FDA Device Registration & Listing · Caesarea Central, IL · Registration 3003623887

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3003623887
FEI Number
3003623887
Entity Name
PHARMASEPT LTD. MEDICAL PRODUCTS
City/State/Country
Caesarea Central, IL
Establishment Address
9 Shaham St., Northern Industrial Park, Caesarea Central 3088900, IL
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
PHARMASEPT LTD. MEDICAL PRODUCTS (Owner Number: 9045710)
Owner / Operator Contact Address
9 Shaham St., Northern Industrial Park, Caesarea, IL-NOTA 3088900, IL
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

S11103 Pajunk Labeled Safersonic Conti with Gel S11101 Pajunk Labeled Safersonic Single with Gel DAN-33512NWG Safersonic Conti Narrow with Gel DAN-33803WG Safersonic Single with Gel DAN-33805WG Safersonic Medium with Gel DAN-33825WG to Safersonic Long with Gel DAN-33505NWG Safersonic Medium Narrow with Gel DAN-33812WG to Safersonic Conti with Gel PSC Florida VMD90-4518 MS DRAPE For Zeiss W/HLT ANGLE LENS 45”x118”, 115x300cm MU8090HR Microscope Cover MITAKA 120/390 HLT VMD80-4518 Microscope Cover LEICA 115/300, 7 HLT VMD80-5449 Leica Microscope Cover W/Angle Lens 54” x 149” (137cm X 380cm) MU8090HRSN Microscope Cover MITAKA mm80, mm90, 80/266 Protective Cover 115*300 product code 80-412 HSD01 Protective Cover, HAWKSIGHT DRAPE MU5153 Mitaka MM51 cover VMD90-5449 Microscope Cover ZEISS 137/380 6.50 HLT MU8190HRSN Microscope Cover MITAKA mm80, mm90, 80/276 MU8090HRW Microscope Cover MITAKA 137/380 HLT S11103 Pajunk Labeled Safersonic Single S11104 Pajunk Labeled Safersonic Conti DAN-33805U Safersonic Medium Non Sterile DAN-33803U Safersonic Single Non Sterile DAN-33812U Safersonic Conti Non Sterile DAN-33825 Safersonic Long DAN-33803 Safersonic Single DAN-33805 Safersonic Medium DAN-33825U Safersonic Long Non Sterile DAN-33812 Safersonic Conti DAN-33803NT Safersonic Single - No Tape 4565 C-Arm Cover 152/265 4600 Mini C-Arm Cover & X-Ray Drape 105/220 88-300 C-Arm Cover Philips Veradius Unity 3 pieces 4625 Mini C-Arm Cover & X-Ray Drape 138/160 4444-HP C-Arm Cover UNIVERSAL 112/183 8070 Universal Handle Cover 4444 C-Arm Cover UNIVERSAL 112/183 5028 Protective Cover 80/100cm 5021 Protective Cover 100/100cm 88-742 C-ARM Kit 5004 Image Cover 65R 4445 C-Arm Cover IMAGE INTENSHFIER 115/240 5024 Protective Cover 75/75cm 5052A Protective Cover 95/75cm with Adhesive BUY0549 Protective Cover- Scout Arm 5113 VIDEO - Laser Camera Cover 22*243 88-741 C-ARM 5006 Image Cover 45R BUY0887 Protective Cover- Cart 5054 Protective Cover 90/90cm 4130 C-Arm Cover Siemens "SIREMOBIL 2000" 3 pieces 5110 Video Camera Cover 15/250cm 5026 Protective Cover 75/90cm 5120 X-Ray Cassette Cover 5002 Image Cover 36R BUY0548 Protective Cover- Arm 88-740 Mini C-ARM 137/213 BUY0546 Protective Cover- Screen

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MUI Media, Coupling, Ultrasound Radiology Class 2 892.1570 2023-06-21
HRM Microscope, Operating & Accessories, Ac-Powered, Ophthalmic General, Plastic Surgery Class 1 878.4700 2001-04-20
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2016-11-30
KQM Camera, Surgical And Accessories General, Plastic Surgery Class 1 878.4160 2001-04-20

Official Correspondent

No official correspondent registered.

US Agent Details

Kevin Walls Business: Regulatory Insight, Inc. Email: kevin@reginsight.com Phone: (720) 9625412

Related Public Records

Same Entity

PHARMASEPT LTD. MEDICAL PRODUCTS
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003623887. Last updated year: 2026. Please use registration number 3003623887 when referencing this establishment in official correspondence.
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