Wexler Surgical, Inc. - WEXLER SURGICAL, INC.

Duns Number:024882552

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More Product Details

Catalog Number

-

Brand Name

Wexler Surgical, Inc.

Version/Model Number

FL6111.21

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)

-

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

HTD

Product Code Name

Forceps

Device Record Status

Public Device Record Key

892d09c1-cbbf-4149-8cd5-7782e8e7a841

Public Version Date

November 24, 2021

Public Version Number

6

DI Record Publish Date

November 22, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"WEXLER SURGICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 30
2 A medical device with a moderate to high risk that requires special controls. 22