FDA UDI
In Commercial Distribution
🇺🇸 United States
APC™ PLUS Unitek™ Mini Uni-Twin
DI: 00652221093271
·
Model: 5020-513
·
3M UNITEK CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
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Basic Information
- Brand Name
- APC™ PLUS Unitek™ Mini Uni-Twin
- Primary DI
- 00652221093271
- Version / Model
- 5020-513
- Catalog Number
- 5020-513
- Company Name
- 3M UNITEK CORPORATION
- Labeler DUNS
- 008256356
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 4
- Public Version Date
- 2021-11-01
- Public Version Status
- Update
- Public Device Record Key
- 496cfd11-da18-4ae7-807a-34cf09ac9993
Device Description
Mini Uni-Twin(TM) Bracket APC(TM) PLUS Sondhi UL2 14T/9A Hk .022 5/Pk
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| DYH | ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN | Dental | 872.3750 | 2 |
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 |
|---|---|---|---|---|---|---|
| Primary | 00652221093271 | GS1 | ||||
| Unit of Use | 80652221093277 | GS1 |
Customer Contacts
- Phone
- +1(800)423-4588
- [email protected]