LINK Instrument - Trial Neck Segment - WALDEMAR LINK GmbH & Co. KG

Duns Number:315675488

Device Description: Trial Neck Segment

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More Product Details

Catalog Number

175-196/35

Brand Name

LINK Instrument

Version/Model Number

175-196/35

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

HWT

Product Code Name

Template

Device Record Status

Public Device Record Key

fc76a226-0bda-4218-a27b-a00468043a15

Public Version Date

August 23, 2019

Public Version Number

3

DI Record Publish Date

November 23, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"WALDEMAR LINK 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. 3922
U Unclassified 42