Flexarm Surgical Holders and Positioners - CystoAssist System - FlexArm Mini, Cysto Sheath - FLEXBAR MACHINE CORPORATION

Duns Number:047644935

Device Description: CystoAssist System - FlexArm Mini, Cysto Sheath Holding Tip (Storz compat), Mount Post, R CystoAssist System - FlexArm Mini, Cysto Sheath Holding Tip (Storz compat), Mount Post, Rail Clamp

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More Product Details

Catalog Number

-

Brand Name

Flexarm Surgical Holders and Positioners

Version/Model Number

87000-S

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

dbc51387-1357-44e6-96e0-d57e10446d48

Public Version Date

August 19, 2022

Public Version Number

1

DI Record Publish Date

August 11, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FLEXBAR MACHINE CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 882
2 A medical device with a moderate to high risk that requires special controls. 595