FDA UDI
In Commercial Distribution
🇺🇸 United States
EXAFAST™
DI: 10386040000673
·
Model: 137407
·
Gc America Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- EXAFAST™
- Primary DI
- 10386040000673
- Version / Model
- 137407
- Catalog Number
- 137407
- Company Name
- Gc America Inc.
- Labeler DUNS
- 005473608
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-07-07
- Public Version
- 1
- Public Version Date
- 2022-07-15
- Public Version Status
- New
- Public Device Record Key
- 2e49cf56-81fc-479f-af0c-f99e91b071f4
Device Description
EXAFAST™ NDS Monophase (purple) Two Packs (2 x 48mL cartridges, 6 x mixing tips)
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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Package | 20386040000670 | GS1 | Carton | 16 | In Commercial Distribution | |
| Primary | 10386040000673 | GS1 |
Customer Contacts
- Phone
- +1(708)597-0900
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K955932 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- Low: 23 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- Low: 73 Degrees Fahrenheit