FDA UDI
In Commercial Distribution
🇺🇸 United States
Forceps Capsulorhexis Utrata Round Handle, SS, ST
DI: 05060480408517
·
Model: 11-5012
·
BLINK MEDICAL LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Forceps Capsulorhexis Utrata Round Handle, SS, ST
- Primary DI
- 05060480408517
- Version / Model
- 11-5012
- 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
- 63f135d8-dd30-4877-b480-bf744268f0df
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 |
|---|---|---|---|---|
| HNR | Forceps, Ophthalmic | Ophthalmic | 886.4350 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62673 | Ophthalmic soft-tissue manipulation forceps, tweezers-like, single-use | A sterile, hand-held manual surgical instrument designed to facilitate grasping, manipulation or clamping of, and/or removal of foreign bodies from, ophthalmic soft-tissues (ocular tissues, eyelids), and may be pointed for capsulorhexis. It has a conventional (self-opening) or reverse-action (self-closing) tweezers-like design, with variously designed tips at the working end, whereby the blades are designed to be opened/closed by squeezing between the fingers (i.e., without ring handles); it is not probe-like in design (i.e., not cannulated). It is typically made of metal, available in various sizes, and may have carbide inserts at the working end. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060480408517 | GS1 | ||||
| Package | 05060480401761 | GS1 | 10 | In Commercial Distribution |