Aquaplast RT™ - Aquaplast RT Slim Org U-Frame, Std, 4.8mm - Qfix

Duns Number:808875397

Device Description: Aquaplast RT Slim Org U-Frame, Std, 4.8mm

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More Product Details

Catalog Number

RT-1989SO

Brand Name

Aquaplast RT™

Version/Model Number

RT-1989SO

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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

Yes

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

K935067

Product Code Details

Product Code

IYE

Product Code Name

Accelerator, linear, medical

Device Record Status

Public Device Record Key

6a39a84f-cb41-4b71-b761-4611c47a485a

Public Version Date

December 28, 2021

Public Version Number

1

DI Record Publish Date

December 20, 2021

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