Baha - Spray clip (for Osscora handpiece), 3pcs - Cochlear Bone Anchored Solutions AB

Duns Number:559784736

Device Description: Spray clip (for Osscora handpiece), 3pcs

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More Product Details

Catalog Number

91891

Brand Name

Baha

Version/Model Number

91891

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)

-

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

GEY

Product Code Name

MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Device Record Status

Public Device Record Key

04f06871-e107-4087-b2b0-397d16cc23b6

Public Version Date

August 09, 2019

Public Version Number

4

DI Record Publish Date

July 03, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"COCHLEAR BONE ANCHORED SOLUTIONS AB" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 25
2 A medical device with a moderate to high risk that requires special controls. 276