FDA UDI
In Commercial Distribution
🇺🇸 United States
Lacrimal Plug
DI: 00812444028775
·
Model: ESK-1004
·
RIVERPOINT MEDICAL, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Lacrimal Plug
- Primary DI
- 00812444028775
- Version / Model
- ESK-1004
- Company Name
- RIVERPOINT MEDICAL, LLC
- Labeler DUNS
- 964053560
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-10-01
- Public Version
- 2
- Public Version Date
- 2019-04-12
- Public Version Status
- Update
- Public Device Record Key
- 9bbb5275-0217-4ce0-b95c-328cc304ac2b
Device Description
Canalicular Plug
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LZU | Plug, Punctum | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36237 | Lacrimal punctum plug | A sterile device inserted into a punctal opening to prevent tear outflow in dry eye patients. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00812444028775 | GS1 | ||||
| Package | 10812444028772 | GS1 | 10 | In Commercial Distribution |