Identity
- Trade Name
- Batrik Corner Pockets FDA UDI
- Generic Name
- Instrument tray corner protector, reusable FDA UDI
- Device Name
- NON-STERILE CORNER PROTECTORS EUDAMEDFoam Corner Pockets Protectors, Blue, Single Use(6" x 6" x 1.50") (15.2cm x 15.2cm x 3.8cm) FDA UDI
- Model / Reference
- 18-CPF-02 EUDAMED18-CPF02 FDA UDI
- Description
- Foam Corner Pockets Protectors, Blue, Single Use(6" x 6" x 1.50") (15.2cm x 15.2cm x 3.8cm) FDA UDI
Identifiers
- Catalog Number
- 18-CPF02 FDA UDI
- Primary DI / UDI-DI
- 00690521013940 EUDAMEDFDA UDI
- Basic UDI-DI
- 6905210CORNERP1000EE EUDAMED
- FDA Product Code
- MDM FDA UDI
- EMDN Code
- S9080 DEVICES FOR STERILISATION (EXCLUDING CAT. D - Z) - ACCESSORIES EUDAMED
- GMDN Term
- Instrument tray corner protector, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Ireland 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
Category: Sterilizer/disinfector rack
Non-Sterile Corner Protectors by Batrik Medical Manufacturing Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 6905210CORNERP1000EE | 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 a40907fa-4c5e-45b3-a3c0-3c918f61c0c8 61 fields · synced Jul 10, 2026
- FDA UDI d3c9fc98-3264-4c01-ab26-0282700bfc25 36 fields · synced May 30, 2026