Duns Number:089569581
Device Description: PrimaPro GentleWare Polyethylene Isolation Gown with Thumbholes 3XL, 15 Gowns/Box, 5 Box/C PrimaPro GentleWare Polyethylene Isolation Gown with Thumbholes 3XL, 15 Gowns/Box, 5 Box/Case, 75 Gowns/Case, Single Use
Catalog Number
3XL-PE-GOWN
Brand Name
PrimaPro
Version/Model Number
3XL-PE-GOWN
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
-
Product Code
FME
Product Code Name
Gown, Examination
Public Device Record Key
1bd650ba-56e3-43d0-8f1d-6589bd1e9c49
Public Version Date
September 01, 2021
Public Version Number
1
DI Record Publish Date
August 24, 2021
Package DI Number
10850022371599
Quantity per Package
5
Contains DI Package
00850022371592
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE