FDA UDI
In Commercial Distribution
🇺🇸 United States
3M™
DI: 04054596648791
·
Model: 69408
·
3M Deutschland GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- 3M™
- Primary DI
- 04054596648791
- Version / Model
- 69408
- Catalog Number
- 69408
- Company Name
- 3M Deutschland GmbH
- Labeler DUNS
- 315731711
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-10-02
- Public Version
- 1
- Public Version Date
- 2020-10-12
- Public Version Status
- New
- Public Device Record Key
- 195cd6c0-fd44-42f2-9449-d5d954495410
Device Description
3M™ Polyether Contact Tray Adhesive Refill, 69408
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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| EBH | Material, Impression Tray, Resin | Dental | 872.3670 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16658 | Dental impression material adhesive | A liquid material specifically made to give adhesion of an impression material to the impression tray. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04054596648791 | GS1 |
Customer Contacts
- Phone
- 1(800)634-2249
- [email protected]