Duns Number:314482980
Catalog Number
18910-01A
Brand Name
Disposable Radiolucent Skull Pins (3 Pcs)
Version/Model Number
18910-01A
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
Yes
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
K122225,K122225
Product Code
HBL
Product Code Name
Holder, Head, Neurosurgical (Skull Clamp)
Public Device Record Key
1ce84d1c-f407-4436-82cc-94581b9bb80d
Public Version Date
July 08, 2021
Public Version Number
4
DI Record Publish Date
September 15, 2016
Package DI Number
04056481132217
Quantity per Package
10
Contains DI Package
04056481004767
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 48 |
2 | A medical device with a moderate to high risk that requires special controls. | 685 |