FDA UDI
In Commercial Distribution
🇺🇸 United States
ACRIFIX
DI: EDEL13513300
·
Model: 1351330
·
DeltaMed GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ACRIFIX
- Primary DI
- EDEL13513300
- Version / Model
- 1351330
- Catalog Number
- 1351330
- Company Name
- DeltaMed GmbH
- Labeler DUNS
- 344805101
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-05-12
- Public Version
- 1
- Public Version Date
- 2023-05-22
- Public Version Status
- New
- Public Device Record Key
- 7ba9f73e-eb83-464d-b3ef-3efad66d1d33
Device Description
ACRIFIX rosa/pink 3g
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 |
|---|---|---|---|---|
| EBI | Resin, Denture, Relining, Repairing, Rebasing | Dental | 872.3760 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16727 | Dental prosthesis restorative material, unfilled resin | A material designed to repair dental prostheses that consists of an unfilled polymeric resin. The material works as a bonding agent to provide a strong and long-lasting attachment to the segments of a broken or cracked prosthesis; it typically consists of a single or two-component polymeric (e.g., acrylic) resin that usually becomes a solid polymer when treated with light and/or heat. The material is used in a dentist?s office or dental laboratory to repair fixed dental prostheses and/or partial or total dentures. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | EDEL13513300 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K230341 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- avoid direct sunlight
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 25 Degrees Celsius