Duns Number:107105876
Device Description: CAGE WEASEL INSTRUMENTS TREPHINE 18mm
Catalog Number
273802180
Brand Name
CAGE WEASEL
Version/Model Number
273802180
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2019
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
-
Product Code
HWK
Product Code Name
TREPHINE
Public Device Record Key
80306400-89c5-4896-a68a-a318a9d9edbd
Public Version Date
December 31, 2019
Public Version Number
4
DI Record Publish Date
December 31, 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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 5839 |
2 | A medical device with a moderate to high risk that requires special controls. | 2784 |
U | Unclassified | 20 |