Duns Number:081057389
Device Description: Non-Reinforced Surgical Gown with Set-In Sleeves, XXL - Handi-Bin
Catalog Number
45182NS
Brand Name
Halyard
Version/Model Number
45182
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
K842115,K842115,K842115
Product Code
KKX
Product Code Name
Drape, surgical
Public Device Record Key
9b91e599-964e-4193-aa89-769a2a80e8a2
Public Version Date
November 01, 2021
Public Version Number
5
DI Record Publish Date
July 24, 2019
Package DI Number
30680651451829
Quantity per Package
12
Contains DI Package
20680651451822
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CS
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1044 |