Identity
- Trade Name
- Batrik Pin Guard\.054"\Dark Red w/sleeve FDA UDI
- Generic Name
- Surgical instrument guard, single-use FDA UDI
- Device Name
- PIN-KAPS NON-STERILE EUDAMEDPin Guards, 0.054" (1.40 mm), Dark Red, Non-sterile, with sleeve FDA UDI
- Model / Reference
- 914-1054-SLV EUDAMEDFDA UDI
- Description
- Pin Guards, 0.054" (1.40 mm), Dark Red, Non-sterile, with sleeve FDA UDI
Identifiers
- Catalog Number
- 914-1054-SLV FDA UDI
- Primary DI / UDI-DI
- 00690521014541 EUDAMEDFDA UDI
- Basic UDI-DI
- 6905210PKNS1000VA EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- T0399 PROTECTION DEVICES (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT PPE) - OTHER EUDAMED
- GMDN Term
- Surgical instrument guard, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Austria 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
Pin-Kaps Non-Sterile by Batrik Medical Manufacturing Inc. — Class I — 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 | 6905210PKNS1000VA | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 10d785b3-849d-4dd8-bd5b-f4235d909fc8 61 fields · synced Jun 18, 2026
- FDA UDI 66e82377-76b7-400b-8bf4-7049c051a239 36 fields · synced May 29, 2026