Centurion - STERILE NEWS TRACH HOOK(83300) - CENTURION MEDICAL PRODUCTS CORPORATION

Duns Number:017246562

Device Description: STERILE NEWS TRACH HOOK(83300)

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More Product Details

Catalog Number

67810

Brand Name

Centurion

Version/Model Number

67810

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

GDG

Product Code Name

HOOK, SURGICAL, GENERAL & PLASTIC SURGERY

Device Record Status

Public Device Record Key

d09b7dd7-ef5f-450c-b528-f53aafb788a8

Public Version Date

January 10, 2022

Public Version Number

1

DI Record Publish Date

January 01, 2022

Additional Identifiers

Package DI Number

30653160196703

Quantity per Package

20

Contains DI Package

00653160196702

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"CENTURION MEDICAL PRODUCTS CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6043
2 A medical device with a moderate to high risk that requires special controls. 4077
U Unclassified 1