Identity
- Trade Name
- Medtronic Reusable Instruments FDA UDI
- Generic Name
- Surgical flat-nosed pliers FDA UDI
- Device Name
- PLIERS EX0412079 DISTRACTOR 5.5/6.0 FDA UDI
- Model / Reference
- EX0412079 FDA UDI
- Description
- PLIERS EX0412079 DISTRACTOR 5.5/6.0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643169177628 FDA UDI
- FDA Product Code
- HTC FDA UDI
- GMDN Term
- Surgical flat-nosed pliers FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical flat-nosed pliers
Medtronic Reusable Instruments by Medtronic Sofamor Danek, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Surgical flat-nosed pliers.
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- STOMA® — Storz am Mark GmbH · Class I
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Medtronic Sofamor Danek, Inc.
Sources (1)
- FDA UDI d5b64d18-b960-48aa-ad23-73aca95dc159 34 fields · synced Jun 6, 2026