FDA UDI
In Commercial Distribution
🇺🇸 United States
Blu-Mousse®
DI: 10810000524539
·
Model: S457S-K
·
PARKELL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
2
Basic Information
- Brand Name
- Blu-Mousse®
- Primary DI
- 10810000524539
- Version / Model
- S457S-K
- Catalog Number
- S457S-K
- Company Name
- PARKELL, INC.
- Labeler DUNS
- 009900424
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2021-09-24
- Public Version
- 3
- Public Version Date
- 2024-01-26
- Public Version Status
- Update
- Public Device Record Key
- 1e56ed47-f3a8-46d1-9f86-197213548438
Device Description
Super-Fast Blu-Mousse® Split-Cartridge System (Korea)
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 |
|---|---|---|---|---|
| ELW | Material, Impression | Dental | 872.3660 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35866 | Silicone dental impression material | An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00810000524228 | GS1 | ||||
| Primary | 10810000524539 | GS1 |
Customer Contacts
- Phone
- 6312491134
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Excessive heat will shorten shelf-life. After initial use, store in a cool, dark place with used mixing tip tightly screwed on.
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 25 Degrees Celsius