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Polarstem Chili Pepper Starter Rasp Awl
EUDAMEDFDA UDIClass I (EU MDR)
Ref C1016
Identity
- Trade Name
- Polarstem Chili Pepper Starter Rasp Awl EUDAMEDInnomed, Inc. FDA UDI
- Generic Name
- Bone awl, reusable FDA UDI
- Device Name
- Awl EUDAMEDPolarstem Chili Pepper Starter Rasp Awl FDA UDI
- Model / Reference
- C1016 EUDAMEDFDA UDI
- Description
- Polarstem Chili Pepper Starter Rasp Awl FDA UDI
Identifiers
- Catalog Number
- C1016 FDA UDI
- Primary DI / UDI-DI
- 00840277125910 EUDAMEDFDA UDI
- Basic UDI-DI
- 8402771INNOAWL01K7 EUDAMED
- Direct Marketing DI
- 00840277125910 EUDAMED
- FDA Product Code
- HWJ FDA UDI
- EMDN Code
- L0927 ORTHOPAEDIC SURGERY MANUAL PERFORATORS, REUSABLE EUDAMED
- GMDN Term
- Bone awl, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Polarstem Chili Pepper Starter Rasp Awl by Innomed, 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 | 8402771INNOAWL01K7 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Innomed, Inc.
- EUDAMED SRN
- US-MF-000014761
- Authorised Representative
- MediMark Europe Sarl. FR-AR-000000182
Sources (2)
- EUDAMED e4d53a99-737b-46db-8a1c-fc693a7eb0ba 61 fields · synced Jun 17, 2026
- FDA UDI 6dc2ddb0-63de-4f3e-a4d9-0b76d0b70f7f 34 fields · synced May 30, 2026