StrongArm Surgical Holders and Positioners - Elliquence Scope Positioning Device - FLEXBAR MACHINE CORPORATION

Duns Number:047644935

Device Description: Elliquence Scope Positioning Device

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More Product Details

Catalog Number

-

Brand Name

StrongArm Surgical Holders and Positioners

Version/Model Number

10-8000

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

65678fdb-16fc-441f-a3ca-ff44e3df69e4

Public Version Date

September 21, 2020

Public Version Number

1

DI Record Publish Date

September 11, 2020

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