FDA UDI
In Commercial Distribution
🇺🇸 United States
CorNeat EverPatch
DI: G16010362950
·
Model: 1007691
·
CORNEAT VISION LTD
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- CorNeat EverPatch
- Primary DI
- G16010362950
- Version / Model
- 1007691
- Catalog Number
- 1036295
- Company Name
- CORNEAT VISION LTD
- Labeler DUNS
- 531917352
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-12-05
- Public Version
- 2
- Public Version Date
- 2024-02-19
- Public Version Status
- Update
- Public Device Record Key
- de38a0ba-17a3-4d43-85aa-d63d6b562684
Device Description
Permanent Tissue-Integrating Surgical Matrix
Device Characteristics
- Single Use
- Yes
- 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
- MR Safe
- 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 |
|---|---|---|---|---|
| QWU | Prosthesis, Eyelid Spacer/Graft, Polymer | Ophthalmic | 886.3130 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60300 | Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable | An implantable material (e.g., flat sheet) made from a non-bioabsorbable synthetic polymer(s) [e.g., polyglycolic acid (PGA), polycarbonate (PC), polyglycolide or carbon fibres] intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]. Disposable devices associated with implantation may be supplied with the mesh. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | G16010362951 | HIBCC | Shipping Box | 10 | In Commercial Distribution | |
| Primary | G16010362950 | HIBCC | ||||
| Package | G16010362952 | HIBCC | Sterilization Box | 40 | In Commercial Distribution |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 5.0 mm X 6.5 mm X 100 um |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius