Centurion - STERILE LABEL (WATERTOWN ORTHO) - CENTURION MEDICAL PRODUCTS CORPORATION

Duns Number:017246562

Device Description: STERILE LABEL (WATERTOWN ORTHO)

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More Product Details

Catalog Number

STL1866AB

Brand Name

Centurion

Version/Model Number

STL1866AB

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

fcade087-61f8-4b08-ba14-5b3a595d343c

Public Version Date

December 07, 2021

Public Version Number

1

DI Record Publish Date

November 29, 2021

Additional Identifiers

Package DI Number

10653160349167

Quantity per Package

100

Contains DI Package

20653160349164

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