FDA UDI
In Commercial Distribution
🇺🇸 United States
Manipulator Kuglen Angled
DI: 05060745557264
·
Model: 41-4014
·
BLINK MEDICAL LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Manipulator Kuglen Angled
- Primary DI
- 05060745557264
- Version / Model
- 41-4014
- Company Name
- BLINK MEDICAL LIMITED
- Labeler DUNS
- 738288096
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-10-09
- Public Version
- 1
- Public Version Date
- 2023-10-17
- Public Version Status
- New
- Public Device Record Key
- b26da3d0-fbc2-4e73-b5c2-eeb710a50961
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 |
|---|---|---|---|---|
| HND | Spatula, Ophthalmic | Ophthalmic | 886.4350 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44359 | Ophthalmic surgical probe, single-use | A slender, rod-like, hand-held manual surgical instrument intended to be used during an ophthalmic procedure to explore, measure, and/or manipulate ocular tissues (e.g., retraction/manipulation of intraocular structures, lens nucleus splitting, removal of foreign bodies in the eye, LASIK flap lifting); it is neither intended to cut tissue nor hook muscles. It is available with a variety of tip shapes including blunt bulbous, hook and T-shape, and the shaft may be straight or bent; it is made of flexible or rigid metallic and/or synthetic polymer material. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05060745557271 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 05060745557264 | GS1 |