FDA UDI
Not in Commercial Distribution
🇺🇸 United States
3M™
DI: J001702011055360
·
Model: 77121
·
3M Deutschland GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- 3M™
- Primary DI
- J001702011055360
- Version / Model
- 77121
- Catalog Number
- 77121
- Company Name
- 3M Deutschland GmbH
- Labeler DUNS
- 315731711
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 4
- Public Version Date
- 2018-12-10
- Public Version Status
- Update
- Public Device Record Key
- 2d8b6be4-c103-4663-bfeb-a97078a0356f
- Distribution End Date
- 2017-04-01
Device Description
77121 VISIO ALFA LIGHT UNIT 110V NA
Device Characteristics
- Single Use
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| EBF | MATERIAL, TOOTH SHADE, RESIN | Dental | 872.3690 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35761 | Dental laboratory curing unit | A mains electricity (AC-powered) device used in the dental laboratory for curing polymer-based materials. This can be achieved by heat, heat and pressure, light, or a combination of these. For a curing light used chairside see the appropriate GMDN code. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | J001702011055360 | HIBCC |
Customer Contacts
- Phone
- +1(800)634-2249
- [email protected]