27ga Awh Brilliant Chandelier, 19ga Needle Connector - 27ga Awh Brilliant Chandelier, 19ga Needle - KATALYST SURGICAL LLC

Duns Number:007883297

Device Description: 27ga Awh Brilliant Chandelier, 19ga Needle Connector

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More Product Details

Catalog Number

-

Brand Name

27ga Awh Brilliant Chandelier, 19ga Needle Connector

Version/Model Number

V2105-27R

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

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

MPA

Product Code Name

Endoilluminator

Device Record Status

Public Device Record Key

0a3b0a71-59f7-49a8-8b20-167115f54c6e

Public Version Date

April 01, 2020

Public Version Number

1

DI Record Publish Date

March 24, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KATALYST SURGICAL LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1640
2 A medical device with a moderate to high risk that requires special controls. 288