FDA UDI
In Commercial Distribution
🇺🇸 United States
Identic Alginate
DI: 10841396116558
·
Model: 27475DX
·
Kerr Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
30
Basic Information
- Brand Name
- Identic Alginate
- Primary DI
- 10841396116558
- Version / Model
- 27475DX
- Company Name
- Kerr Corporation
- Labeler DUNS
- 199354556
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 30
- Record Status
- Published
- Publish Date
- 2017-08-31
- Public Version
- 3
- Public Version Date
- 2021-10-11
- Public Version Status
- Update
- Public Device Record Key
- 6bf5ee31-7d29-4e7a-b31f-b4a787c1c562
Device Description
Fast Set DustFree Alginate Dental Impression Material Institutional Pack (30 1 lb. bags)
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 |
|---|---|---|---|---|
| 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 | 10841396116558 | GS1 | ||||
| Unit of Use | 00841396116551 | GS1 |
Customer Contacts
- Phone
- +18005377123
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K160441 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Each 1lb bag: Mixed Vol. 1400 mL |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at room temperature in a tightly closed container. Keep away from sunlight. Keep dry.