Duns Number:006999858
Device Description: Promax Backless Pathology Gown, 1-Ply Front Aqua ProMax, 2-Ply Aqua ProMax Sleeves, 1-Ply Promax Backless Pathology Gown, 1-Ply Front Aqua ProMax, 2-Ply Aqua ProMax Sleeves, 1-Ply Aqua MLR Panel with Negastat Backs, Color Coded Tie Closures at Neck & Waist, Poly Cuffs, Size Medium
Catalog Number
75674166
Brand Name
Promax Backless Pathology Gown
Version/Model Number
75674166
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"
-
For Single-Use
-
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
K041540,K041540
Product Code
FYA
Product Code Name
Gown, Surgical
Public Device Record Key
3d3e01f1-b47b-4903-bfee-759751aca511
Public Version Date
April 07, 2021
Public Version Number
2
DI Record Publish Date
April 03, 2020
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 | 26 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |