PIN DRIVER - Gebr. Brasseler GmbH & Co. KG

Duns Number:317409001

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More Product Details

Catalog Number

GS900.130.000

Brand Name

PIN DRIVER

Version/Model Number

GS900.130.000.Q5

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

-

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 Details

Product Code

GFC

Product Code Name

Driver, Surgical, Pin

Device Record Status

Public Device Record Key

b9bbe3b8-de08-474f-ac6f-a68bd741f91f

Public Version Date

July 07, 2021

Public Version Number

1

DI Record Publish Date

June 29, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GEBR. BRASSELER GMBH & CO. KG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 154
2 A medical device with a moderate to high risk that requires special controls. 70