FDA UDI
Not in Commercial Distribution
🇺🇸 United States
3M™
DI: 00605861074742
·
Model: EXD-987
·
3M COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- 3M™
- Primary DI
- 00605861074742
- Version / Model
- EXD-987
- Catalog Number
- EXD-987
- Company Name
- 3M COMPANY
- Labeler DUNS
- 830016148
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-01-03
- Public Version
- 2
- Public Version Date
- 2023-03-03
- Public Version Status
- Update
- Public Device Record Key
- 831d18f9-ebfa-42f4-a452-9c6800da066b
- Distribution End Date
- 2022-03-01
Device Description
3M™ Custom Matrix
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KCQ | TUBE IMPRESSION AND MATRIX | Dental | 872.6570 | 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 |
|---|---|---|---|---|---|---|
| Primary | 00605861074742 | GS1 |
Customer Contacts
- Phone
- +1(800)228-3957
- [email protected]