FDA UDI
In Commercial Distribution
🇺🇸 United States
MucoHard™
DI: 00810000525683
·
Model: S641
·
PARKELL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MucoHard™
- Primary DI
- 00810000525683
- Version / Model
- S641
- Catalog Number
- S641
- Company Name
- PARKELL, INC.
- Labeler DUNS
- 009900424
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-06-24
- Public Version
- 2
- Public Version Date
- 2023-01-11
- Public Version Status
- Update
- Public Device Record Key
- 9b568a1e-55fc-4415-8153-3b1731c78688
Device Description
MucoHard™+ Cartridge Refill
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 |
|---|---|---|---|---|
| EBI | Resin, Denture, Relining, Repairing, Rebasing | Dental | 872.3760 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17609 | Denture reliner, hard | A denture relining material intended to be applied by a dentist or dental laboratory technician as a permanent coating or lining on the base or tissue-contact surface of a denture and which sets to a hard state. Denture relining is defined as a process of providing a new fitting surface to a denture. 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 | 00810000525683 | GS1 |
Customer Contacts
- Phone
- 6312491134
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in refrigerator with cap or used mixing tip tightly screwed on. Avoid freezing. Bring to room temp before use. Avoid storing near excessive heat, light or fresh eugenol containing material.
- Type
- Storage Environment Temperature
- Temperature Range
- 18 – 24 Degrees Celsius