FDA UDI
In Commercial Distribution
🇺🇸 United States
Conjunctival Probe
DI: 05060480408647
·
Model: CP01
·
BLINK MEDICAL LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Conjunctival Probe
- Primary DI
- 05060480408647
- Version / Model
- CP01
- 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
- 0693bae3-3159-4227-ae56-ee534d9b459b
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 |
|---|---|---|---|---|
| 64435 | Conjunctival trocar blade | A rigid, hand-held, manual ophthalmic surgical instrument with a sharp tip intended to puncture and create an opening in the conjunctiva, typically to facilitate a sub-Tenon’s block with a local anaesthetic agent. It is typically used as an alternative to conjunctival scissors. It is not intended to fill the lumen of an ophthalmic cannula and is not designed for transscleral access. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060480408647 | GS1 | ||||
| Package | 05060480402898 | GS1 | 10 | In Commercial Distribution |