FDA UDI
In Commercial Distribution
🇺🇸 United States
Diamatrix
DI: 00813059017604
·
Model: DPXT05
·
Diamatrix
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Diamatrix
- Primary DI
- 00813059017604
- Version / Model
- DPXT05
- Catalog Number
- DPXT05
- Company Name
- Diamatrix
- Labeler DUNS
- 809555139
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-07-12
- Public Version
- 1
- Public Version Date
- 2021-07-20
- Public Version Status
- New
- Public Device Record Key
- 37ea6a87-e411-43aa-b214-0332468883c6
Device Description
DACRIOS 0.5mm X 2mm PCL (Extended Wear) Punctal Plug, Box of 10
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
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 | 00813059017604 | GS1 |
Customer Contacts
- Phone
- 2813678081
- [email protected]