VacQfix™ - Vac-Q-Fix Cushion, 120xm x 70cm, 40L Fill Gen.II - Qfix

Duns Number:808875397

Device Description: Vac-Q-Fix Cushion, 120xm x 70cm, 40L Fill Gen.II (Economy valve)

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More Product Details

Catalog Number

RT-4517-70120F40M

Brand Name

VacQfix™

Version/Model Number

RT-4517-70120F40M

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K060671

Product Code Details

Product Code

JAI

Product Code Name

Couch, radiation therapy, powered

Device Record Status

Public Device Record Key

457b5ab9-3c82-46f6-831b-3b8fe8272a96

Public Version Date

February 11, 2022

Public Version Number

1

DI Record Publish Date

February 03, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"QFIX" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 84
2 A medical device with a moderate to high risk that requires special controls. 998