Guide Pin 10 mm - Laboratory component for prior generation Vistafix - Cochlear Bone Anchored Solutions AB

Duns Number:559784736

Device Description: Laboratory component for prior generation Vistafix

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More Product Details

Catalog Number

90794

Brand Name

Guide Pin 10 mm

Version/Model Number

90794

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

FZE

Product Code Name

PROSTHESIS, NOSE, INTERNAL

Device Record Status

Public Device Record Key

dd2d0544-479a-40f3-bda5-2964758dbc90

Public Version Date

December 21, 2020

Public Version Number

5

DI Record Publish Date

June 07, 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