Identity
- Trade Name
- Batrik Non-Sterile Red Clamp Jaw Cover FDA UDI
- Generic Name
- Clamp jaw cover, non-sterile FDA UDI
- Device Name
- Non-Sterile Clamp Jaw Covers EUDAMED"Clamp Jaw Covers, Radio Opaque, Non-Sterile, Red, 0.1"" x 5"" / 0.25cm x 12.7 cm" FDA UDI
- Model / Reference
- 912-1000 EUDAMEDFDA UDI
- Description
- "Clamp Jaw Covers, Radio Opaque, Non-Sterile, Red, 0.1"" x 5"" / 0.25cm x 12.7 cm" FDA UDI
Identifiers
- Catalog Number
- 912-1000 FDA UDI
- Primary DI / UDI-DI
- 00690521011090 EUDAMEDFDA UDI
- Basic UDI-DI
- 6905210CJCNS100N8 EUDAMED
- FDA Product Code
- HCF FDA UDI
- EMDN Code
- L80 SURGICAL INSTRUMENTS, REUSABLE - VARIOUS ACCESSORIES EUDAMED
- GMDN Term
- Clamp jaw cover, non-sterile FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Malta EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Non-Sterile Clamp Jaw Covers by Batrik Medical Manufacturing Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6905210CJCNS100N8 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Batrik Medical Manufacturing Inc.
- EUDAMED SRN
- CA-MF-000007738
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 3b475ceb-efef-4aaf-b984-ba81f322959d 61 fields · synced Jun 17, 2026
- FDA UDI 72c6783c-b81c-452e-8ae4-e08342e07171 36 fields · synced May 30, 2026