FDA UDI
In Commercial Distribution
🇺🇸 United States
3M™ Victory Series™
DI: 00652221117014
·
Model: 953-381
·
3M UNITEK CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- 3M™ Victory Series™
- Primary DI
- 00652221117014
- Version / Model
- 953-381
- Catalog Number
- 953-381
- Company Name
- 3M UNITEK CORPORATION
- Labeler DUNS
- 008256356
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2022-12-08
- Public Version
- 1
- Public Version Date
- 2022-12-16
- Public Version Status
- New
- Public Device Record Key
- 92a7a6eb-ab5f-4930-96e8-7a1d2fb41d32
Device Description
3M™ Victory Series™ First Molar Bands, 953-381, Lower, Left, Standard, Contoured, Hard, Size 140+, Ea
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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ECM | BAND, PREFORMED, ORTHODONTIC | Dental | 872.5410 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46581 | Orthodontic bracket, metal | A metallic device that is bonded to an orthodontic band, or directly to a tooth, to hold an orthodontic wire and/or other appliance (e.g., rubber bands) used to apply pressure to the tooth in order to alter the position of the tooth. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 80652221117010 | GS1 | ||||
| Primary | 00652221117014 | GS1 |
Customer Contacts
- Phone
- +1(800)228-3957
- [email protected]