Instrument Protectors (including Osteotome Protectors +2 more)
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- Batrik Instrument Protectors FDA UDI
- Generic Name
- Surgical instrument guard, single-use FDA UDI
- Device Name
- Instrument Protectors (including Osteotome Protectors, Double Protectors, & Retractor Protectors) EUDAMEDInstrument Protectors, Perforated, Tinted Black, 0.125" x 1" x 1" (3.18 mm x 25.4 mm x 25.4 mm) FDA UDI
- Model / Reference
- PT-09 EUDAMEDFDA UDI
- Description
- Instrument Protectors, Perforated, Tinted Black, 0.125" x 1" x 1" (3.18 mm x 25.4 mm x 25.4 mm) FDA UDI
Identifiers
- Catalog Number
- PT-09 FDA UDI
- Primary DI / UDI-DI
- 00690521002036 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
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Device sterilization/disinfection container, reusable
Instrument Protectors (including Osteotome Protectors +2 more) by Batrik Medical Manufacturing Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID…
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
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 e31b0c9f-ef6c-4c48-8dda-868f3850ada1 61 fields · synced Sep 18, 2026
- FDA UDI f9ef7c7a-eb9f-4a6f-ad8c-1f5ffd9990ba 36 fields · synced May 27, 2026