FDA UDI
In Commercial Distribution
🇺🇸 United States
Rocatec™ Plus
DI: 04035077004787
·
Model: 68376
·
3M Deutschland GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Rocatec™ Plus
- Primary DI
- 04035077004787
- Version / Model
- 68376
- Catalog Number
- 68376
- Company Name
- 3M Deutschland GmbH
- Labeler DUNS
- 315731711
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-08-08
- Public Version
- 4
- Public Version Date
- 2018-09-21
- Public Version Status
- Update
- Public Device Record Key
- 9a0779b9-e48c-4254-9429-511c37d03840
Device Description
3M™ ESPE™ Rocatec™ Plus Micro-Abrasion Bonding/Coating For Metal, Ceramic And Plastic Materials Refill, 68376
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
- 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 |
|---|---|---|---|---|
| EJH | ALLOY, METAL, BASE | Dental | 872.3710 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62477 | Dental composite resin kit | A collection of non-sterile substances intended for professional use during dental restoration and prosthesis installation/repair which includes composite resin material and additional materials to support restoration (e.g., etching solution, bonding agent, primer, prosthesis bonding agents, unfilled resin sealant/coating agents), and may include dedicated disposable devices associated with application; it does not include non-resin-based cements nor dental prosthesis. 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 | 04035077004787 | GS1 | ||||
| Direct Marking | 04035077024143 | GS1 |
Customer Contacts
- Phone
- +1(800)634-2249
- [email protected]