Duns Number:961027315
Device Description: BACK TABLE COVER 44X75 LL 22/CS
Catalog Number
8145W
Brand Name
CONVERTORS
Version/Model Number
8145W
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 01, 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
c353e7de-6151-4bf7-8fad-e5c9ebae63af
Public Version Date
September 01, 2022
Public Version Number
4
DI Record Publish Date
May 09, 2018
Package DI Number
50885380034334
Quantity per Package
22
Contains DI Package
00885380034339
Package Discontinue Date
September 01, 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 |