FaceGuard™ - FaceGuard Flat Frame - FaceGuard Universal Frame, - Dan Allen Surgical LLC

Duns Number:040876183

Device Description: FaceGuard Flat Frame - FaceGuard Universal Frame, width-adjustable. For use with FaceGuard FaceGuard Flat Frame - FaceGuard Universal Frame, width-adjustable. For use with FaceGuard Flat Tray (00811836030518) or Dual-Angle Tray (00811836030501).

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More Product Details

Catalog Number

-

Brand Name

FaceGuard™

Version/Model Number

69200

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

BWN

Product Code Name

Table And Attachments, Operating-Room

Device Record Status

Public Device Record Key

612b472e-b9a9-445a-be13-db9630a873c2

Public Version Date

October 24, 2022

Public Version Number

4

DI Record Publish Date

May 17, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DAN ALLEN SURGICAL LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 28