MEDLINE - KIDNEY RETRIEVAL - CENTURION MEDICAL PRODUCTS CORPORATION

Duns Number:017246562

Device Description: KIDNEY RETRIEVAL

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More Product Details

Catalog Number

DYNDJ1079

Brand Name

MEDLINE

Version/Model Number

DYNDJ1079

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

FMH

Product Code Name

CONTAINER, SPECIMEN, STERILE

Device Record Status

Public Device Record Key

30ac4a8d-f118-422c-8e8e-da81d24087e3

Public Version Date

June 17, 2022

Public Version Number

3

DI Record Publish Date

April 13, 2020

Additional Identifiers

Package DI Number

20193489196808

Quantity per Package

30

Contains DI Package

10193489196801

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