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

VL0712.3

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

HNR

Product Code Name

Forceps, Ophthalmic

Device Record Status

Public Device Record Key

3ab258d4-c59f-4380-a3e8-706b8ef022fb

Public Version Date

December 02, 2021

Public Version Number

2

DI Record Publish Date

September 23, 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