Duns Number:030124221
Device Description: Handpiece Tray for GYN Lower Genital Handpiece Set (GYN-HS-LGT)
Catalog Number
GYN-TRAY-LGT
Brand Name
GYN-LGT Handpiece Tray
Version/Model Number
GYN-TRAY-LGT
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K081939
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
43d26f23-f3e9-4c15-b1a9-382502ad73b0
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 22, 2016
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 60 |