Identity
- Trade Name
- Universal Graftgun Kit FDA UDI
- Generic Name
- Orthopaedic cement ultrasonic surgical system handpiece tip, reusable FDA UDI
- Model / Reference
- RED-U-1000 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810131881290 FDA UDI
- 510(k) Number
- K243580 FDA UDI
- FDA Product Code
- FMF FDA UDI
- GMDN Term
- Orthopaedic cement ultrasonic surgical system handpiece tip, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5860 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
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
Category: Orthopaedic cement ultrasonic surgical system handpiece tip, reusable
Universal Graftgun Kit by Surgentec Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic cement ultrasonic surgical system handpiece tip, reusable.
- Graftgun Universal Kit – Additional 5cc Graftgun Tube — SURGENTEC LLC · Class II
- Plat Tip Adapter – Small — SURGENTEC LLC · Class II
- Narrow Tip Adapter Package — SURGENTEC LLC · Class II
- Plat Tip Adapter – Medium — SURGENTEC LLC · Class II
- Bullet Tip Adapter Package — SURGENTEC LLC · Class II
- Global Tip Adapter Package — SURGENTEC LLC · Class II
- Plat Tip Adapter – Large — SURGENTEC LLC · Class II
Cleared under the same submission
K243580 also covers:
- Bullet Tip Adapter Package — SURGENTEC LLC
- Global Tip Adapter Package — SURGENTEC LLC
- Graftgun Universal Kit – Additional 5cc Graftgun Tube — SURGENTEC LLC
- Narrow Tip Adapter Package — SURGENTEC LLC
- Plat Tip Adapter – Large — SURGENTEC LLC
- Plat Tip Adapter – Medium — SURGENTEC LLC
- Plat Tip Adapter – Small — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Surgentec Llc
Sources (1)
- FDA UDI a1cd43e2-64c3-444c-ba2c-cc02ab47c54e 33 fields · synced May 31, 2026