Duns Number:005085972
Device Description: Giles De Quincey Tunneling Instrument 2
Catalog Number
FQUINCEY2
Brand Name
Hu-Friedy
Version/Model Number
FQUINCEY2
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EMF
Product Code Name
Knife, Surgical
Public Device Record Key
8bb56b32-b2a3-4177-8d2a-911d1436193e
Public Version Date
September 29, 2021
Public Version Number
1
DI Record Publish Date
September 21, 2021
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 | 7436 |
2 | A medical device with a moderate to high risk that requires special controls. | 238 |