Duns Number:257382580
Device Description: Conformers (made of acrylic or PMMA) are single use devices. They are used to keep the for
Catalog Number
-
Brand Name
Bilateral Conformer 18/20 Small, In Bulk
Version/Model Number
19-102V
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 21, 2019
Issuing Agency
In HIBCC
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
37000e53-deb6-4b9f-b0a0-c5b6e0d0110b
Public Version Date
October 22, 2019
Public Version Number
3
DI Record Publish Date
October 16, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 192 |
2 | A medical device with a moderate to high risk that requires special controls. | 88 |