FDA UDI
In Commercial Distribution
🇺🇸 United States
GraftGun Universal Graft Delivery System - Additional 5cc Graft Tube - IOSAL
DI: 00810131881122
·
Model: GG-T-01-IB
·
SURGENTEC, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- GraftGun Universal Graft Delivery System - Additional 5cc Graft Tube - IOSAL
- Primary DI
- 00810131881122
- Version / Model
- GG-T-01-IB
- Company Name
- SURGENTEC, LLC
- Labeler DUNS
- 004095409
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-02-12
- Public Version
- 1
- Public Version Date
- 2025-02-20
- Public Version Status
- New
- Public Device Record Key
- 3302b18e-8554-4e3c-9ba5-e7c2914a8a18
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FMF | Syringe, Piston | General Hospital | 880.5860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64258 | Syringe dose safety regulator | A non-powered device intended to be used by a healthcare provider to help safely administer a precise dose of medication from a (prefilled) syringe to a patient. It is in the form of a rod with volume graduations, secured alongside the syringe plunger, which includes a perpendicular sliding lock intended to mechanically obstruct the movement of the plunger into the syringe barrel beyond the desired volume mark, for safe medication administration. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810131881122 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K170675 | 000 |