Endo-Kerrison
FDA UDIEUDAMEDClass I (US FDA UDI)
by Joimax, Inc.
Identity
- Trade Name
- Endo-Kerrison Pistol Handle EUDAMEDEndo-Kerrison FDA UDI
- Generic Name
- Flexible endoscopic biopsy forceps, reusable FDA UDI
- Device Name
- Endo-Kerrison Shaft EUDAMEDEndo-Kerrison Pistol Handle FDA UDI
- Model / Reference
- EKH350000. EUDAMEDFDA UDI
- Description
- Endo-Kerrison Pistol Handle FDA UDI
Identifiers
- Catalog Number
- EKH350000. FDA UDI
- Primary DI / UDI-DI
- 04250337114970 EUDAMEDFDA UDI
- Basic UDI-DI
- 42503371PUNCHENDWR EUDAMED
- Direct Marketing DI
- 04250337114970 EUDAMED
- FDA Product Code
- LRY FDA UDI
- EMDN Code
- L1199 NEUROSURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Flexible endoscopic biopsy forceps, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Flexible endoscopic biopsy forceps, reusable
Endo-Kerrison by Joimax, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Joimax, Inc.
Sources (2)
- FDA UDI 8e68b30b-02c0-436c-8fe9-806c07ad1962 36 fields · synced Jul 31, 2026
- EUDAMED 40be9400-931d-46f0-82b5-fb6fb06d2746 61 fields · synced Jul 31, 2026