Centurion - BIOPSY RADIOLOGY STERILE PACK - CENTURION MEDICAL PRODUCTS CORPORATION

Duns Number:017246562

Device Description: BIOPSY RADIOLOGY STERILE PACK

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More Product Details

Catalog Number

STL2938

Brand Name

Centurion

Version/Model Number

STL2938

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

LYV

Product Code Name

LABEL OR TAG, STERILE

Device Record Status

Public Device Record Key

05cd244b-fa71-4e20-bbd0-8bfe224e618b

Public Version Date

January 10, 2022

Public Version Number

1

DI Record Publish Date

January 02, 2022

Additional Identifiers

Package DI Number

10653160232018

Quantity per Package

100

Contains DI Package

00653160232011

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