Duns Number:763408366
Device Description: An ophthalmic device, typically constructed from moulded plastic, that is intended to be i 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.
Catalog Number
-
Brand Name
SILICONE CONFORMER (FLEXIBLE)
Version/Model Number
S6.2001
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HQN
Product Code Name
Conformer, Ophthalmic
Public Device Record Key
9068b761-a168-490e-a2c9-fe8f06746d31
Public Version Date
June 07, 2021
Public Version Number
1
DI Record Publish Date
May 30, 2021
Package DI Number
13760087122586
Quantity per Package
1
Contains DI Package
03760087122589
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 82 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 291 |
| U | Unclassified | 60 |