Centurion Medical Products Corp - EP INSTRUMENT SET - MEDLINE INDUSTRIES, INC.

Duns Number:025460908

Device Description: EP INSTRUMENT SET

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

MNS13885

Brand Name

Centurion Medical Products Corp

Version/Model Number

MNS13885

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

FSM

Product Code Name

TRAY, SURGICAL, INSTRUMENT

Device Record Status

Public Device Record Key

43ef2c6d-8e8c-4b7f-abbf-99caea6e03aa

Public Version Date

August 01, 2022

Public Version Number

1

DI Record Publish Date

July 24, 2022

Additional Identifiers

Package DI Number

40653160993460

Quantity per Package

12

Contains DI Package

10653160993469

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"MEDLINE INDUSTRIES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 38540
2 A medical device with a moderate to high risk that requires special controls. 85094
3 A medical device with high risk that requires premarket approval 2
U Unclassified 7