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Instrument Protectors (including Osteotome Protectors +2 more)
EUDAMEDFDA UDIClass I (EU MDR)
Ref RGM-01
Identity
- Trade Name
- Batrik Retractor Protectors FDA UDI
- Generic Name
- Surgical instrument guard, single-use FDA UDI
- Device Name
- Instrument Protectors (including Osteotome Protectors, Double Protectors, & Retractor Protectors) EUDAMEDRetractor Protectors "Weitlaner", Small, Pink FDA UDI
- Model / Reference
- RGM-01 EUDAMEDFDA UDI
- Description
- Retractor Protectors "Weitlaner", Small, Pink FDA UDI
Identifiers
- Catalog Number
- RGM-01 FDA UDI
- Primary DI / UDI-DI
- 00690521002340 EUDAMEDFDA UDI
- Basic UDI-DI
- 6905210INSTPRO1000V4 EUDAMED
- FDA Product Code
- MDM FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Surgical instrument guard, single-use FDA UDI
- Models / Variants
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 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
Instrument Protectors (including Osteotome Protectors +2 more) by Batrik Medical Manufacturing Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID…
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 | 6905210INSTPRO1000V4 | 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 e8d31071-9140-4d57-8746-7f73dc8c694b 61 fields · synced Jul 9, 2026
- FDA UDI fa39376b-3f25-4022-af33-d04a2e1ef9c2 36 fields · synced May 30, 2026