Duns Number:110555005
Device Description: 100% POLYPROPYLENE NON-SURGICAL PROTECTIOVE GOWN, OVER THE HEAD, AAMI LEVEL 2 MEDICAL, NON 100% POLYPROPYLENE NON-SURGICAL PROTECTIOVE GOWN, OVER THE HEAD, AAMI LEVEL 2 MEDICAL, NON-SURGICAL, DISPOSABLE, CLOSED BACK, SINGLE USE
Catalog Number
-
Brand Name
FRUIT HEALTH
Version/Model Number
PI.421EGHT.O6J.XL.0.0
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)
Yes
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
b41d2a0f-ddb9-4abc-85df-47bcdbd53cd4
Public Version Date
April 27, 2022
Public Version Number
1
DI Record Publish Date
April 19, 2022
Package DI Number
10194422108264
Quantity per Package
10
Contains DI Package
00194422108267
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
POLY BAG