Bilateral Conformer 22 Regular
- Primary DI
- M872190940
- Brand
- Bilateral Conformer 22 Regular
- Company
- Oculo-Plastik Inc
- Model
- 19-094
- Device description
- Conformers (made of acrylic or PMMA) are single use devices. They are used to keep the form of the orbital cavity after enucleation or evisceration. In fact, a well chosen conformer enhances healing and prevents retraction of the cul-de-sac. It facilitates the fabrication and the retention of the ocular prosthesis. The conformer temporarily takes the place of the volume lost after enucleation or evisceration and keeps the lids in their natural position. It can be inserted in both eyes (left eye or right eye). The conformer is inserted behind the lids at the end of the surgery and stays in place until the next appointment with the ophthalmologist and/or the ocularist before an ocular prosthesis is made. This period of time varies for each patient and can range between one (1) to four (4) weeks. The conformer is never worn for more than 30 days continuously.
- Published
- 2019-10-18
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Safe
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Related Records
Contact Domains
Product Codes
| Code | Name |
|---|---|
| HQN | Conformer, Ophthalmic |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| HQN | Conformer, Ophthalmic | Ophthalmic | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| M872190940 | Previous | HIBCC | 0 | |
| 10697660001057 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 10697660001057 | 10697660001057 |
GMDN Terms
| Term | Definition |
|---|---|
| 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. |
Device Sizes
| Type | Value | Unit |
|---|---|---|
| Depth | 1.8 | Millimeter |
| Length | 28 | Millimeter |
| Width | 23 | Nanometer |
Sterilization Methods
| Method |
|---|
| Ethylene Oxide;Hydrogen Peroxide |
| Hydrogen Peroxide;Ethylene Oxide |
Contacts
| Phone | |
|---|---|
| 514-381-3292 | sales@oculoplastik.com |
Regulatory Flags
- DUNS number
- 257382580
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
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