FDA UDI
In Commercial Distribution
🇺🇸 United States
Integra® Miltex®
DI: 10381780509387
·
Model: 33-234
·
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
3
Basic Information
- Brand Name
- Integra® Miltex®
- Primary DI
- 10381780509387
- Version / Model
- 33-234
- Catalog Number
- 33-234
- Company Name
- INTEGRA LIFESCIENCES PRODUCTION CORPORATION
- Labeler DUNS
- 081277700
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 3
- Record Status
- Published
- Publish Date
- 2018-10-23
- Public Version
- 3
- Public Version Date
- 2023-05-15
- Public Version Status
- Update
- Public Device Record Key
- 7a5ec1c0-3dab-45ec-8723-6fd636a1647c
Device Description
Miltex® Replacement Drill Points Miltex Nail drill set of 3
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
- 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 |
|---|---|---|---|---|
| MDM | INSTRUMENT, MANUAL, SURGICAL, GENERAL USE | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11337 | Fingernail drill bit | A shaft of metal designed to penetrate a fingernail or toenail to access the underlying tissue, typically to relieve pressure from a subungual haematoma (release of blood/fluid accumulated in the underlying nail bed). It is inserted into an appropriate drilling device and typically has a ball-shaped cutting head that, when rotated, cuts through the tissue of the nail. It is available with various cutting head shapes and sizes. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Secondary | H834332341 | HIBCC | ||||
| Primary | 10381780509387 | GS1 | ||||
| Unit of Use | 00381780509380 | GS1 |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]