FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Symblepharon Ring - 22mm
DI: B091143460
·
Model: 14346
·
Gulden Ophthalmics Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Symblepharon Ring - 22mm
- Primary DI
- B091143460
- Version / Model
- 14346
- Catalog Number
- 14346
- Company Name
- Gulden Ophthalmics Inc.
- Labeler DUNS
- 002373249
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 3
- Public Version Date
- 2023-07-03
- Public Version Status
- Update
- Public Device Record Key
- aa9d553d-1309-450a-8811-b847785a4b3a
- Distribution End Date
- 2023-06-29
Device Description
Symblepharon rings are effective in keeping ocular fornices formed after surgery, in situations where conjunctival cicatricial disease is present, or after ocular trauma such as chemical burns or avulsion of the conjunctiva. The ring prevent adhesions and shortening or retraction of the fornices and cul-de-sacs without touching the cornea.
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
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Hydrogen Peroxide, Ethylene Oxide
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 | B091143460 | HIBCC |
Customer Contacts
- Phone
- 1-800-659-2200
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 22 | Millimeter |