Duns Number:961027315
Device Description: Subclavian Drape
Catalog Number
C2309
Brand Name
CONVERTORS
Version/Model Number
C2309
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 24, 2022
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
693d6dc7-ec53-44ad-a7b5-d9f541997a6a
Public Version Date
September 26, 2022
Public Version Number
8
DI Record Publish Date
November 27, 2017
Package DI Number
50885380146044
Quantity per Package
20
Contains DI Package
10885380146046
Package Discontinue Date
September 24, 2022
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 |