FDA UDI
In Commercial Distribution
🇺🇸 United States
Dilator Punctal Double Ended
DI: 05060480407930
·
Model: 90-1011
·
BLINK MEDICAL LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Dilator Punctal Double Ended
- Primary DI
- 05060480407930
- Version / Model
- 90-1011
- Company Name
- BLINK MEDICAL LIMITED
- Labeler DUNS
- 738288096
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-06-30
- Public Version
- 1
- Public Version Date
- 2022-07-08
- Public Version Status
- New
- Public Device Record Key
- f9be2e8e-e77a-4bf2-bfca-46351a3810cf
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
- Yes
- 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 |
|---|---|---|---|---|
| HNW | Dilator, Lachrymal | Ophthalmic | 886.4350 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34035 | Lacrimal dilator, single-use | A sterile, hand-held, manual, ophthalmic surgical instrument used for enlarging the lacrimal canal (the lacrimal duct) during an ophthalmic procedure. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060480407930 | GS1 | ||||
| Package | 05060480402430 | GS1 | 10 | In Commercial Distribution |