Duns Number:080361159
Device Description: GOWN, HACKENSACK ISOLATION AAMI LV2, UNIVERSAL, HANDS LOGO, OVER THE HEAD, THUMBLOOP W/ELA GOWN, HACKENSACK ISOLATION AAMI LV2, UNIVERSAL, HANDS LOGO, OVER THE HEAD, THUMBLOOP W/ELASTIC
Catalog Number
-
Brand Name
HACKENSACK
Version/Model Number
HKGNA450L2
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)
Yes
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
LYU
Product Code Name
Accessory, Surgical Apparel
Public Device Record Key
fea8ff56-ad2a-4b44-af57-6bab59bb0ec7
Public Version Date
July 25, 2022
Public Version Number
1
DI Record Publish Date
July 15, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1046 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |
| U | Unclassified | 2 |