Degania - Identi Loops Maxi white 18" sterile - DEGANIA SILICONE LTD

Duns Number:600007082

Device Description: Identi Loops Maxi white 18" sterile

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More Product Details

Catalog Number

-

Brand Name

Degania

Version/Model Number

231141280DS

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"

Yes

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

-

Product Code Details

Product Code

DXC

Product Code Name

Clamp, Vascular

Device Record Status

Public Device Record Key

392b78af-4814-4de3-852d-8869d09d1af3

Public Version Date

May 06, 2020

Public Version Number

2

DI Record Publish Date

January 09, 2019

Additional Identifiers

Package DI Number

47290001603220

Quantity per Package

10

Contains DI Package

27290001603226

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton

"DEGANIA SILICONE LTD" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 20