Ultraphonic, 5 Liter w/ bottle - Ultrasonic Gel - ACCELERATED CARE PLUS CORP

Duns Number:828331616

Device Description: Ultrasonic Gel

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More Product Details

Catalog Number

-

Brand Name

Ultraphonic, 5 Liter w/ bottle

Version/Model Number

32060

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 22, 2022

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

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Device Record Status

Public Device Record Key

fe108ddb-7c38-4eed-910e-58c69009a1a8

Public Version Date

July 25, 2022

Public Version Number

5

DI Record Publish Date

September 06, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ACCELERATED CARE PLUS CORP" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 9