Intussusception Air Reduction kit, no tip - Intussusception Air Reduction kit, no tip - GRI MEDICAL PRODUCTS INC

Duns Number:005875146

Device Description: Intussusception Air Reduction kit, no tip

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More Product Details

Catalog Number

IARK-1

Brand Name

Intussusception Air Reduction kit, no tip

Version/Model Number

IARK-1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

Yes

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

KQT

Product Code Name

Evacuator, Gastro-Urology

Device Record Status

Public Device Record Key

398457b4-88d8-440d-ba9d-6b030e524b34

Public Version Date

December 26, 2019

Public Version Number

1

DI Record Publish Date

December 18, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GRI MEDICAL PRODUCTS INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 7