Identity
- Trade Name
- 5cc Graft Tube Pusher FDA UDI
- Generic Name
- Syringe dose safety regulator FDA UDI
- Model / Reference
- GG-GTP-01 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00858406007068 FDA UDI
- 510(k) Number
- K170675 FDA UDI
- FDA Product Code
- FMF FDA UDI
- GMDN Term
- Syringe dose safety regulator 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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Syringe dose safety regulator
5cc Graft Tube Pusher by Surgentec Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Syringe dose safety regulator.
- GraftGun Universal Graft Delivery System - Additional 5cc Graft Tube - IOSAL — SURGENTEC LLC · Class II
- Impact Rod — SURGENTEC LLC · Class II
- 7.5cc Graft Tube Pusher — SURGENTEC LLC · Class II
- 7.5cc Graft Tube Steel — SURGENTEC LLC · Class II
- GraftGun Universal Kit - IOSAL — SURGENTEC LLC · Class II
- Graftgun® Universal (GDS™) Graft Delivery System- Additional 5cc Graftgun Tube — SURGENTEC LLC · Class II
- 5cc Graft Tube Steel — SURGENTEC LLC · Class II
Cleared under the same submission
K170675 also covers:
- 5cc Graft Tube Steel — SURGENTEC LLC
- 7.5cc Graft Tube Pusher — SURGENTEC LLC
- 7.5cc Graft Tube Steel — SURGENTEC LLC
- Bullet Global Tip Adapter — SURGENTEC LLC
- Bullet Tip Adapter — SURGENTEC LLC
- Cage Adapter - Large — SURGENTEC LLC
- Cage Adapter - Small — SURGENTEC LLC
- Global Tip Adapter — SURGENTEC LLC
- Global Tip Adapter - Long — SURGENTEC LLC
- Global Tip Adapter - Narrow — SURGENTEC LLC
- GraftGun Universal Graft Delivery System - Additional 5cc Graft Tube - IOSAL — SURGENTEC LLC
- GraftGun Universal Kit - IOSAL — 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 dd300fc3-3d62-4753-bdd9-706046368e7b 33 fields · synced Jun 8, 2026