Tensor Surgical - Reusable devices used as a kit to shuttle suture - TENSOR SURGICAL, INC.

Duns Number:051885419

Device Description: Reusable devices used as a kit to shuttle suture through bone

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More Product Details

Catalog Number

3000

Brand Name

Tensor Surgical

Version/Model Number

3000

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

64af0ca7-c171-4b20-abf4-4322983ee917

Public Version Date

June 17, 2022

Public Version Number

2

DI Record Publish Date

June 09, 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