FDA UDI
In Commercial Distribution
🇺🇸 United States
Small Conformer (non-sterile)
DI: B091141641
·
Model: 14164
·
Gulden Ophthalmics Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
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Basic Information
- Brand Name
- Small Conformer (non-sterile)
- Primary DI
- B091141641
- Version / Model
- 14164
- Catalog Number
- 14164
- Company Name
- Gulden Ophthalmics Inc.
- Labeler DUNS
- 002373249
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 14f9763c-51de-48cf-89ed-7febceabeb52
Device Description
Conformer is temporarily implanted between the eye ball and the eye lid to protect sutures and to prevent adhesion of the eye lid onto the eye sac. The Conformer also prevents the orbital socket from closing in on itself during the healing process and forces the muscles to conform around it.
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 |
|---|---|---|---|---|
| 16065 | Ophthalmic conformer | An ophthalmic device, typically constructed from moulded plastic, that is intended to be inserted temporarily between the eyeball and eyelid to maintain space in the orbital cavity and prevent closure or adhesions during the healing process following eye surgery. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B091141641 | HIBCC | ||||
| Unit of Use | B091141640 | HIBCC |
Customer Contacts
- Phone
- 1-800-659-2250
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 0.87 | Inch | |
| Length | 0.75 | Inch |