Duns Number:421272799
Device Description: Surgical Gown With Reinforcement, M, AAMI PB70 Level 3, 1 piece/bag, 28 pieces/carton
Catalog Number
-
Brand Name
Zhende SG-WR
Version/Model Number
ZD23101K
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
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
FYA
Product Code Name
Gown, Surgical
Public Device Record Key
5010fb84-3d17-4d6c-9564-c3a8dfe422ee
Public Version Date
April 07, 2021
Public Version Number
2
DI Record Publish Date
August 31, 2020
Package DI Number
06971004783272
Quantity per Package
28
Contains DI Package
06971004783265
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |