Medline - TUBE, GUIDEWIRE, 1.1MM X 150MM - MEDLINE INDUSTRIES, INC.

Duns Number:025460908

Device Description: TUBE, GUIDEWIRE, 1.1MM X 150MM

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More Product Details

Catalog Number

MSGWTUBE2

Brand Name

Medline

Version/Model Number

MSGWTUBE2

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

-

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

2778dff1-4d4d-499f-9867-01912560af4f

Public Version Date

September 17, 2020

Public Version Number

1

DI Record Publish Date

September 09, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

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