FDA UDI
In Commercial Distribution
🇺🇸 United States
Quintess Tear Pool
DI: 00850048647114
·
Model: 20-5405
·
El Paso Medical, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Quintess Tear Pool
- Primary DI
- 00850048647114
- Version / Model
- 20-5405
- Company Name
- El Paso Medical, LLC
- Labeler DUNS
- 131183053
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-01-10
- Public Version
- 1
- Public Version Date
- 2024-01-18
- Public Version Status
- New
- Public Device Record Key
- 9a56053f-817d-4ac3-8889-beb54780aeae
Device Description
Tear Pool Dissolvable Punctum Plugs, Tear Pool Pack, 0.5mm, sterile.
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
- 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 | 00850048647114 | GS1 | ||||
| Package | 10850048647111 | GS1 | 2 | In Commercial Distribution |