Tensor Surgical VersaTip Suture Shuttle - Device used for capturing suture and making - TENSOR SURGICAL, INC.

Duns Number:051885419

Device Description: Device used for capturing suture and making repairs

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More Product Details

Catalog Number

4010

Brand Name

Tensor Surgical VersaTip Suture Shuttle

Version/Model Number

4010

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"

Yes

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

7151e909-2b12-4eab-8c95-71309006533a

Public Version Date

June 17, 2022

Public Version Number

2

DI Record Publish Date

June 15, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TENSOR SURGICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1