FDA UDI
In Commercial Distribution
🇺🇸 United States
SYMBLEPHARON RING 22 MM
DI: 13700773724922
·
Model: S6.2422
·
FCI S A S FCI 20 22
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SYMBLEPHARON RING 22 MM
- Primary DI
- 13700773724922
- Version / Model
- S6.2422
- Company Name
- FCI S A S FCI 20 22
- Labeler DUNS
- 763408366
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-05-30
- Public Version
- 1
- Public Version Date
- 2021-06-07
- Public Version Status
- New
- Public Device Record Key
- 99c974f1-edb5-4a60-a156-e0c9809b2e34
Device Description
SYMBLEPHARON RING 22 MM
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
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HQN | Conformer, Ophthalmic | Ophthalmic | 886.3130 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16073 | Symblepharon ring, synthetic | An implantable device formed as a circular band used to help prevent the eyelid from adhering to the eyeball. It is used occasionally in the case of, e.g., glaucoma, to keep raw surfaces separated. The device is made of synthetic material, e.g., polytetrafluoroethylene (PTFE), commonly known as Teflon, a polymer, or copolymer material. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 13700773724922 | GS1 |