Shukla Shoulder S9SHLDR - Shoulder Stem Extractor Jaw, Cylinder - Shukla Medical

Duns Number:159009294

Device Description: Shoulder Stem Extractor Jaw, Cylinder

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More Product Details

Catalog Number

-

Brand Name

Shukla Shoulder S9SHLDR

Version/Model Number

STP036

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

LXH

Product Code Name

Orthopedic Manual Surgical Instrument

Device Record Status

Public Device Record Key

73706b55-12f8-4a75-aa11-d477ce7c37c8

Public Version Date

August 09, 2022

Public Version Number

1

DI Record Publish Date

August 01, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SHUKLA MEDICAL" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 706