Medline - TOTAL 1-LAYER TRAY, LATEX FOLEY, 18FR 10 - MEDLINE INDUSTRIES, INC.

Duns Number:025460908

Device Description: TOTAL 1-LAYER TRAY, LATEX FOLEY, 18FR 10

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More Product Details

Catalog Number

URO170118

Brand Name

Medline

Version/Model Number

URO170118

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

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

OHR

Product Code Name

Catheter care tray

Device Record Status

Public Device Record Key

52209f76-6b9d-4f5e-84c1-6eb3efd94f56

Public Version Date

December 04, 2020

Public Version Number

8

DI Record Publish Date

October 14, 2016

Additional Identifiers

Package DI Number

40889942125730

Quantity per Package

10

Contains DI Package

10889942125739

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"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