FDA UDI
In Commercial Distribution
🇺🇸 United States
gSource
DI: 00840314242808
·
Model: gS 81.6730
·
GSOURCE LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- gSource
- Primary DI
- 00840314242808
- Version / Model
- gS 81.6730
- Catalog Number
- gS 81.6730
- 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
- 2022-08-22
- Public Version Status
- Update
- Public Device Record Key
- dd98582b-3f2c-4955-8b52-0f81ff283661
Device Description
Wire Extraction Pliers 7" DA 3mm TC
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 |
|---|---|---|---|---|
| JEX | Plier, Orthodontic | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38830 | Wire-extracting pliers | A manual surgical instrument specially designed to grip the end of a wire, typically the self-boring type, for its extraction from the patient's body. It has a scissors-like design with strong curved handles and short pointed jaws that are heavily serrated to grip the end of the wire for extraction. It is made of high-grade stainless steel and some types can have a threaded screw that the surgeon tightens which increases the pressure (the grip) on the jaws. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840314242808 | GS1 |