FDA UDI
In Commercial Distribution
🇺🇸 United States
gSource
DI: 00840314243195
·
Model: gS 82.0100
·
GSOURCE LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- gSource
- Primary DI
- 00840314243195
- Version / Model
- gS 82.0100
- Catalog Number
- gS 82.0100
- Company Name
- GSOURCE LLC
- Labeler DUNS
- 008162518
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-02-26
- Public Version
- 2
- Public Version Date
- 2022-09-30
- Public Version Status
- Update
- Public Device Record Key
- 77dfc85c-c76d-425d-979f-7859604cbc62
Device Description
Vickers Manual K-Wire Driver 5 1/2"
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35436 | Manual wire driver | A hand-held manual surgical instrument (drill-like) designed to drive orthopaedic bone wires, e.g., Steinmann pins, Kirschner wires or K-Wires (thin needle-like pins of different thickness that are pointed for self-drilling) into fractured/deformed bones for their restoration. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840314243195 | GS1 |