Duns Number:831375089
Device Description: OR Towel, 17" x 26" Sterile, Blue
Catalog Number
8321B
Brand Name
PremierPro
Version/Model Number
8321B
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KKX
Product Code Name
Drape, Surgical
Public Device Record Key
77fcd4a3-1ede-47db-8fb7-6a160756f74a
Public Version Date
December 22, 2021
Public Version Number
6
DI Record Publish Date
June 15, 2016
Package DI Number
10818566010732
Quantity per Package
80
Contains DI Package
00818566010735
Package Discontinue Date
-
Package Status
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 | 486 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 177 |
| U | Unclassified | 1 |