FDA UDI
In Commercial Distribution
🇺🇸 United States
Integra® Miltex®
DI: 10381780468752
·
Model: 72-41
·
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
144
Basic Information
- Brand Name
- Integra® Miltex®
- Primary DI
- 10381780468752
- Version / Model
- 72-41
- Catalog Number
- 72-41
- Company Name
- INTEGRA LIFESCIENCES PRODUCTION CORPORATION
- Labeler DUNS
- 081277700
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 144
- Record Status
- Published
- Publish Date
- 2018-10-24
- Public Version
- 3
- Public Version Date
- 2023-05-02
- Public Version Status
- Update
- Public Device Record Key
- e1fe5fb8-8ca7-4d6e-a327-5ae4d58e483c
Device Description
Integra® Miltex® Tofflemire Type Matrix Bands, .002/1 - 144 Pack
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
- 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 |
|---|---|---|---|---|
| JEP | RETAINER, MATRIX | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38786 | Dental matrix band, single-use | A band or strip of strong material (typically a transparent plastic) or a short tube that is used to form a mould around a tooth for the insertion of restorative materials. The device is typically held snugly around the tooth by a matrix retainer. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Secondary | H83472411 | HIBCC | ||||
| Primary | 10381780468752 | GS1 | ||||
| Unit of Use | 00381780468755 | GS1 |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]