FDA UDI
In Commercial Distribution
🇺🇸 United States
EaglePlug TearFlow
DI: 00841668114698
·
Model: 3009
·
KATENA PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- EaglePlug TearFlow
- Primary DI
- 00841668114698
- Version / Model
- 3009
- Catalog Number
- 3009
- Company Name
- KATENA PRODUCTS, INC.
- Labeler DUNS
- 085668598
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-03-31
- Public Version
- 4
- Public Version Date
- 2022-02-21
- Public Version Status
- Update
- Public Device Record Key
- 43bba12a-df9a-401f-8cd1-3c43ece721d7
Device Description
EaglePlug TearFlow, Plug 0.9mm D, Lumen 0.4mm D - 2 per box
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
- Yes
- 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 | 00841668114698 | GS1 |
Customer Contacts
- Phone
- (973) 989-1600
- [email protected]