FDA UDI
In Commercial Distribution
🇺🇸 United States
iPRO
DI: 05060654200114
·
Model: FHCEP3
·
FANNIN (UK) LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
Basic Information
- Brand Name
- iPRO
- Primary DI
- 05060654200114
- Version / Model
- FHCEP3
- Company Name
- FANNIN (UK) LIMITED
- Labeler DUNS
- 770174886
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2023-02-23
- Public Version
- 1
- Public Version Date
- 2023-03-03
- Public Version Status
- New
- Public Device Record Key
- 7ba3d8a1-daf1-4aa8-b771-99e6649de69a
Device Description
iPRO ELITE - SKINTACT Eye Protector
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
- Yes
- 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 |
|---|---|---|---|---|
| KGX | Tape And Bandage, Adhesive | General Hospital | 880.5240 | 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 |
|---|---|---|---|---|---|---|
| Primary | 05060654200114 | GS1 | ||||
| Unit of Use | 05060654200671 | GS1 |