LinkBio Instrument - LinkBio Instrument Tray (Mega C): Mega C SL Tibia - Link Bio Corp

Duns Number:827608774

Device Description: LinkBio Instrument Tray (Mega C): Mega C SL Tibia Prep Instruments

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More Product Details

Catalog Number

-

Brand Name

LinkBio Instrument

Version/Model Number

MCSLTP

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

FSM

Product Code Name

Tray, Surgical, Instrument

Device Record Status

Public Device Record Key

df5a8fa0-597c-4c5a-9386-f68e8fce3da3

Public Version Date

September 16, 2022

Public Version Number

4

DI Record Publish Date

May 13, 2021

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