FDA UDI
In Commercial Distribution
🇺🇸 United States
Lacrifill Canalicular Gel
DI: 00369918645018
·
Model: V1
·
AMRING PHARMACEUTICALS INC.
Product Codes
0
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Lacrifill Canalicular Gel
- Primary DI
- 00369918645018
- Version / Model
- V1
- Company Name
- AMRING PHARMACEUTICALS INC.
- Labeler DUNS
- 079843051
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-04-15
- Public Version
- 1
- Public Version Date
- 2024-04-23
- Public Version Status
- New
- Public Device Record Key
- b39354a9-f08b-49c9-8ce5-ecc421de1dad
Device Description
Canalicular gel
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Dry Heat Sterilization
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47569 | Scalpel, single-use | A hand-held, manual surgical instrument constructed as a one-piece handle and scalpel blade (not an exchangeable component) used by the operator to manually cut or dissect tissue. The blade is typically made of high-grade stainless steel alloy or carbon steel and the handle is often made of plastic. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Direct Marking | 00369918645100 | GS1 | ||||
| Primary | 00369918645018 | GS1 |