Disposable Radiolucent Skull Pins (3 Pcs) - Brainlab AG

Duns Number:314482980

Want to know more about this Product? Request more information now!


More Product Details

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

Product Characteristics

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 Details

Product Code

HBL

Product Code Name

Holder, Head, Neurosurgical (Skull Clamp)

Device Record Status

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

Additional Identifiers

Package DI Number

04056481132217

Quantity per Package

10

Contains DI Package

04056481004767

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"BRAINLAB AG" Characteristics
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