Identity
- Trade Name
- Flexible Pusher Tip and Set Screw FDA UDI
- Generic Name
- Bone file/rasp, manual, reusable FDA UDI
- Model / Reference
- 3D-T01-07 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00858406007600 FDA UDI
- 510(k) Number
- K201900 FDA UDI
- FDA Product Code
- HTR FDA UDI
- GMDN Term
- Bone file/rasp, manual, reusable 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
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Bone file/rasp, manual, reusable
Flexible Pusher Tip and Set Screw by Surgentec Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K201900 also covers:
- Bone Graft Funnel — SURGENTEC LLC
- Decortication Rasp - Curved — SURGENTEC LLC
- Decortication Rasp - Fixed Curved — SURGENTEC LLC
- Decortication Rasp - Straight — SURGENTEC LLC
- Decortication Rasp- Straight — SURGENTEC LLC
- GraftRasp Teeth and Set Screw - Bladed — SURGENTEC LLC
- GraftRasp Teeth and Set Screw - Curved — SURGENTEC LLC
- GraftRasp Teeth and Set Screw- Straight — SURGENTEC LLC
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Surgentec Llc
Sources (1)
- FDA UDI 912c6952-3824-4ad3-afb6-06c53dba47ae 33 fields · synced Jun 6, 2026