FDA UDI
In Commercial Distribution
🇺🇸 United States
Safco Contour matrix bands
DI: 10810063752429
·
Model: 1025519
·
SAFCO DENTAL SUPPLY CO.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
Basic Information
- Brand Name
- Safco Contour matrix bands
- Primary DI
- 10810063752429
- Version / Model
- 1025519
- Catalog Number
- 1025519
- Company Name
- SAFCO DENTAL SUPPLY CO.
- Labeler DUNS
- 020417380
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2022-03-03
- Public Version
- 1
- Public Version Date
- 2022-03-11
- Public Version Status
- New
- Public Device Record Key
- 2667654a-8e0c-4e4d-ba71-d79498fd533b
Device Description
Safco contour bands adult .0015 50/bx
Device Characteristics
- Single Use
- Yes
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ECR | SETTER, BAND, ORTHODONTIC | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16195 | Dental matrix band, reusable | A band or strip of strong material (typically stainless steel or transparent polyester) or a short tube that is used to form a mould around a tooth for the insertion of restorative materials. The device is held snugly around the tooth by a matrix retainer or tensioned around the tooth using a dedicated mechanical tensioning device. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00810063752422 | GS1 | ||||
| Primary | 10810063752429 | GS1 |