FDA UDI
In Commercial Distribution
🇺🇸 United States
andorate® Eye Cornea Protectors
DI: 04897106952335
·
Model: GAR001
·
GA Health Company Limited
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- andorate® Eye Cornea Protectors
- Primary DI
- 04897106952335
- Version / Model
- GAR001
- Company Name
- GA Health Company Limited
- Labeler DUNS
- 686908512
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-17
- Public Version
- 2
- Public Version Date
- 2022-03-02
- Public Version Status
- Update
- Public Device Record Key
- 70860f9a-aec3-4883-bb8b-2c756ad31de7
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
- Yes
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HMP | Pad, Eye | General, Plastic Surgery | 878.4440 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61490 | Eye patch | A device intended to be used to close/cover one or both eyes, for the purpose of protecting the eye after a procedure or as part of an ophthalmic therapeutic intervention. It is made of a synthetic or biological 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 | 14897106952332 | GS1 | Box | 100 | In Commercial Distribution | |
| Primary | 04897106952335 | GS1 | ||||
| Package | 24897106952339 | GS1 | Carton | 50 | In Commercial Distribution |