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

DL0300-W

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 15, 2022

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

Yes

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

MDM

Product Code Name

Instrument, Manual, Surgical, General Use

Device Record Status

Public Device Record Key

8f0f54b5-bd7c-4ebd-91da-a27cffdcc0a5

Public Version Date

March 21, 2022

Public Version Number

3

DI Record Publish Date

February 27, 2018

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