Duns Number:079343581
Catalog Number
-
Brand Name
PACKARD HEALTHCARE ISOLATION GOWN L2 ELASTIC CUFF
Version/Model Number
6070553452
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
OEA
Product Code Name
Non-Surgical Isolation Gown
Public Device Record Key
321e9342-428e-4cc5-b552-3a1570e6d1b8
Public Version Date
September 27, 2022
Public Version Number
1
DI Record Publish Date
September 19, 2022
Package DI Number
D89260705534522
Quantity per Package
100
Contains DI Package
D89260705534521
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 | 208 |
2 | A medical device with a moderate to high risk that requires special controls. | 61 |