FDA UDI
In Commercial Distribution
🇺🇸 United States
KROMOPAN
DI: 18016200010328
·
Model: KRM001
·
LASCOD SPA
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- KROMOPAN
- Primary DI
- 18016200010328
- Version / Model
- KRM001
- Company Name
- LASCOD SPA
- Labeler DUNS
- 436269609
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-09-15
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 36597c3a-5571-4fa4-b39c-d2da99b1ac87
Device Description
Chromatic alginate violet / pink / white type 1 (450 g) CATALOGUE NUMBER: - KRM302 = carton box containing n. 20 bags KRM001 - KRM300 = smal carton box containing n. 3 bags KRM001 - KRM203 = plastic jar containing n. 1 bag KRM001
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| 35863 | Alginate dental impression material | A material containing alginate as an essential gel-forming ingredient, which, after mixing with water, reaches a consistency suitable for taking impressions of a patient's teeth and gums, or other oral anatomy. The material is 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 |
|---|---|---|---|---|---|---|
| Primary | 18016200010328 | GS1 | ||||
| Package | 18016200010069 | GS1 | plastic jar | 1 | In Commercial Distribution | |
| Package | 18016200010045 | GS1 | smal carton box | 3 | In Commercial Distribution | |
| Package | 18016200010038 | GS1 | carton box | 20 | In Commercial Distribution |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 25 Degrees Celsius