Identity
- Trade Name
- Batrik Pin-Kaps FDA UDI
- Generic Name
- Surgical instrument guard, single-use, sterile FDA UDI
- Device Name
- Sterile Pin Kaps EUDAMEDPin-Kaps, Sterile, Pink, 0.078" / 1.98 mm FDA UDI
- Model / Reference
- 14-1078 EUDAMEDFDA UDI
- Description
- Pin-Kaps, Sterile, Pink, 0.078" / 1.98 mm FDA UDI
Identifiers
- Catalog Number
- 14-1078 FDA UDI
- Primary DI / UDI-DI
- 00690521014169 EUDAMEDFDA UDI
- Basic UDI-DI
- 6905210PKST100W6 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- A0380 TUBULAR DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Surgical instrument guard, single-use, sterile FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Malta EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Sterile Pin Kaps 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 | 6905210PKST100W6 | 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 37c3cadb-06c8-407e-b17e-698748a61e8b 61 fields · synced Jun 18, 2026
- FDA UDI 22145f7f-15c7-41f8-a231-67cd416e0dea 35 fields · synced May 30, 2026