5 Piece ClikRay (TM) Dexis PEDO/Anterior Holder - 5 Piece ClikRay (TM) Dexis PEDO/Anterior Holder - CLIKTECH LLC

Duns Number:044516217

Device Description: 5 Piece ClikRay (TM) Dexis PEDO/Anterior Holder

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More Product Details

Catalog Number

001-503

Brand Name

5 Piece ClikRay (TM) Dexis PEDO/Anterior Holder

Version/Model Number

001-503

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"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

EGZ

Product Code Name

Holder, Film, X-Ray

Device Record Status

Public Device Record Key

c4260c0b-4440-4991-b284-7c7968bf6d47

Public Version Date

January 08, 2021

Public Version Number

1

DI Record Publish Date

December 31, 2020

Additional Identifiers

Package DI Number

10856200001500

Quantity per Package

16

Contains DI Package

00856200001503

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX

"CLIKTECH LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 84