Duns Number:279456896
Device Description: The HYGITECH transparent bag with sliding bootlace allows to protect the control unit wit
Catalog Number
HY-63117
Brand Name
HYGITECH
Version/Model Number
HY-63117
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
-
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
GFJ
Product Code Name
Mallet, Surgical, General & Plastic Surgery
Public Device Record Key
58903f01-b7e2-4d88-8d1c-a81bae5673ed
Public Version Date
December 15, 2020
Public Version Number
2
DI Record Publish Date
November 25, 2020
Package DI Number
03615140003070
Quantity per Package
25
Contains DI Package
03615140003063
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 |