Taylor Stitcher Punch - Surgical instrument to be used with Superelastic - NCS LAB SRL

Duns Number:429763668

Device Description: Surgical instrument to be used with Superelastic Transosseous Needle (STN).

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More Product Details

Catalog Number

-

Brand Name

Taylor Stitcher Punch

Version/Model Number

P005_AS034_03

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

LXH

Product Code Name

Orthopedic Manual Surgical Instrument

Device Record Status

Public Device Record Key

799539f4-1298-48ea-a508-1da2c9295dba

Public Version Date

June 17, 2022

Public Version Number

1

DI Record Publish Date

June 09, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NCS LAB SRL" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 22
2 A medical device with a moderate to high risk that requires special controls. 11