Duns Number:690677802
Device Description: Table Attachment for 3080, Outside
Catalog Number
07-952-06A
Brand Name
Table Attachment for 3080, Outside
Version/Model Number
07-952-06A
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
-
Product Code
HBL
Product Code Name
Holder, Head, Neurosurgical (Skull Clamp)
Public Device Record Key
dce92002-a1bf-40d8-8732-383daeca30a3
Public Version Date
August 09, 2021
Public Version Number
1
DI Record Publish Date
July 30, 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 | 696 |
2 | A medical device with a moderate to high risk that requires special controls. | 566 |