Duns Number:023904428
Device Description: Surgical Gown FABRIC REINFORCED RAGLAN SLEEVES / STERILE NON-WOVEN WITH HAND TOWEL Surgical Gown FABRIC REINFORCED RAGLAN SLEEVES / STERILE NON-WOVEN WITH HAND TOWEL XXL 53"
Catalog Number
-
Brand Name
McKesson
Version/Model Number
183-i91-4340-S1
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
K102652,K102652
Product Code
FYA
Product Code Name
Gown, Surgical
Public Device Record Key
ddcd7243-714c-4e1a-b17c-2665b6e01e6d
Public Version Date
December 27, 2021
Public Version Number
4
DI Record Publish Date
July 09, 2018
Package DI Number
40612479229301
Quantity per Package
22
Contains DI Package
10612479229294
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 | 870 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 422 |
| U | Unclassified | 44 |