Duns Number:279456896
Device Description: US SURGICAL GOWN L(20)
Catalog Number
HY-5011
Brand Name
HYGITECH
Version/Model Number
HY-5011
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
K121152,K121152,K121152
Product Code
FYA
Product Code Name
Gown, Surgical
Public Device Record Key
22a83904-f848-4568-84ca-6398243cfbdd
Public Version Date
April 07, 2021
Public Version Number
2
DI Record Publish Date
December 16, 2020
Package DI Number
03615140005067
Quantity per Package
20
Contains DI Package
03615140005050
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 87 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |