Duns Number:961027315
Device Description: Ophthalmic Aperture Drape
Catalog Number
C2350A
Brand Name
CONVERTORS
Version/Model Number
C2350A
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 06, 2021
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
PUI
Product Code Name
Drape, surgical, exempt
Public Device Record Key
97070c43-19d6-49d5-879e-91961a15a7a7
Public Version Date
December 22, 2021
Public Version Number
8
DI Record Publish Date
September 28, 2017
Package DI Number
50885380142213
Quantity per Package
10
Contains DI Package
10885380142215
Package Discontinue Date
August 06, 2021
Package Status
Not in Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |