Duns Number:831375089
Device Description: OR Towels Non-Sterile, 100 Bulk, White, 400/cs
Catalog Number
B8320W
Brand Name
PremierPro
Version/Model Number
B8320W
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"
-
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
e17a4b0e-2039-44cc-9635-beec2a7d9e5c
Public Version Date
September 07, 2020
Public Version Number
4
DI Record Publish Date
June 15, 2016
Package DI Number
10818566016611
Quantity per Package
400
Contains DI Package
00818566016614
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 |