LinkBio Instrument - Broach, Tibial Cone XS Half - Link Bio Corp

Duns Number:827608774

Device Description: Broach, Tibial Cone XS Half

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More Product Details

Catalog Number

-

Brand Name

LinkBio Instrument

Version/Model Number

87-1903/01

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

HTQ

Product Code Name

Broach

Device Record Status

Public Device Record Key

fcecdbca-ea8c-44d0-a09f-4994e79ada8c

Public Version Date

June 21, 2022

Public Version Number

1

DI Record Publish Date

June 10, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LINK BIO CORP" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 92