Identity
- Trade Name
- Implant-One FDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- Radiographic Marker (RAM) Surgical Kit FDA UDI
- Model / Reference
- KIT-RAMS-00 FDA UDI
- Description
- Radiographic Marker (RAM) Surgical Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- D762KITRAMS000 FDA UDI
- FDA Product Code
- OFY FDA UDI
- GMDN Term
- Surgical screwdriver, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3980 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical screwdriver, reusableSurgical instrument handle, non-torque-limitingOrthodontic pliersCraniofacial bone screw, non-bioabsorbable, non-sterile
Implant-One by Implant Logistics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Implant Logistics, Inc.
Sources (1)
- FDA UDI b73c4821-1df7-4f3c-a45b-ad2bf20f8099 34 fields · synced May 30, 2026