Duns Number:544515279
Device Description: ULTRA Reinforced Surgical gown, Size LARGE, SINGLE USE ONLY, LEVEL 4 AAMI PB70,Meets req ULTRA Reinforced Surgical gown, Size LARGE, SINGLE USE ONLY, LEVEL 4 AAMI PB70,Meets requirement of ASTM F2407
Catalog Number
-
Brand Name
3A MEDICAL
Version/Model Number
3AJS0001
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 18, 2021
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
-
Product Code
FYA
Product Code Name
Gown, Surgical
Public Device Record Key
9cbfea37-a1b9-4a95-a390-db46ea6b7ecc
Public Version Date
April 07, 2021
Public Version Number
2
DI Record Publish Date
March 18, 2021
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 22 |