FDA UDI
In Commercial Distribution
🇺🇸 United States
APC™ II Level Anchorage™
DI: 00652221059697
·
Model: 3017-767
·
3M UNITEK CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
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Basic Information
- Brand Name
- APC™ II Level Anchorage™
- Primary DI
- 00652221059697
- Version / Model
- 3017-767
- Catalog Number
- 3017-767
- 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
- eae06041-fdad-4b9f-a8c1-ce2bf252fce9
Device Description
Victory Series(TM) Bracket APC(TM) II Level Anchorage Single LL5 -11T/-6A .018 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 | 00652221059697 | GS1 | ||||
| Unit of Use | 80652221059693 | GS1 |
Customer Contacts
- Phone
- +1(800)423-4588
- [email protected]