FDA UDI
In Commercial Distribution
🇺🇸 United States
Tunneling instrument 2,8 mm, str. + cvd., DLC coated, black PEEK handle
DI: 00841336101388
·
Model: MICRO-BLK-TUNNEL-2.8
·
Salvin Dental Specialties, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Tunneling instrument 2,8 mm, str. + cvd., DLC coated, black PEEK handle
- Primary DI
- 00841336101388
- Version / Model
- MICRO-BLK-TUNNEL-2.8
- Company Name
- Salvin Dental Specialties, Inc.
- Labeler DUNS
- 113344790
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-10
- Public Version
- 1
- Public Version Date
- 2023-08-18
- Public Version Status
- New
- Public Device Record Key
- fa2c5c11-45b8-4b27-9ec1-239cb35fe5e8
Device Characteristics
- Single Use
- No
- 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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| NDP | Accessories, Implant, Dental, Endosseous | Dental | 872.3980 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58344 | Tunnelling forceps | A hand-held manual surgical instrument designed to be used to open a soft tissue plane (tunnelling) and to pull an object, typically a tube implant or other device, back through the tunnel. It is made of metal and typically has an elongated, slender, scissors-like design with two blades that close like jaws and ring handles. It may be used during rib/rib cage internal fixation procedures. This is a reusable device intended to be sterilized prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00841336101388 | GS1 |