VersaWrap Tendon Protector - VersaWrap Tendon Protector (K200311) is indicated - ALAFAIR BIOSCIENCES, INC

Duns Number:968882709

Device Description: VersaWrap Tendon Protector (K200311) is indicated for the management and protection of ten

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More Product Details

Catalog Number

VTP1201

Brand Name

VersaWrap Tendon Protector

Version/Model Number

VTP1201

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

MR Safe

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

Yes

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

FTM

Product Code Name

Mesh, Surgical

Device Record Status

Public Device Record Key

a43be059-2d1d-4c8c-a6c0-990fce574921

Public Version Date

October 22, 2020

Public Version Number

1

DI Record Publish Date

October 14, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ALAFAIR BIOSCIENCES, INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 4