FDA UDI
In Commercial Distribution
🇺🇸 United States
EXAlence™
DI: 10386040006125
·
Model: 150300
·
Gc America Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
Basic Information
- Brand Name
- EXAlence™
- Primary DI
- 10386040006125
- Version / Model
- 150300
- Catalog Number
- 150300
- Company Name
- Gc America Inc.
- Labeler DUNS
- 005473608
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- 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
- beca7372-e445-473e-adf0-a2abe37bd6bd
Device Description
EXA’lence™ Accessories GC Intra-Oral Tips, 100pcs
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
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- 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 |
|---|---|---|---|---|
| 16807 | Pharmaceutical fluid-dispensing system | A assembly of devices used in a hospital and/or other healthcare facility to dispense fluids by combining in a given ratio several liquid components from a set of source containers into a container with the final product (i.e., it compounds drugs according to a specified medical prescription). It is typically a mains electricity (AC-powered) automated or semi-automated device that includes a set of standardized source liquid containers each attached with tubes to a compounding device which output is in turn attached to the final liquid container. It may also include a control panel to facilitate the introduction of manual or bar-coded mixing and/or checking instructions. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00386040006128 | GS1 | ||||
| Primary | 10386040006125 | GS1 |
Customer Contacts
- Phone
- +1(708)597-0900
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K955932 | 000 |