Medline Industries, Inc. - GUIDEWIRE .038X145 3MMJ FC - MEDLINE INDUSTRIES, INC.

Duns Number:025460908

Device Description: GUIDEWIRE .038X145 3MMJ FC

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More Product Details

Catalog Number

DYNJGWIRE36

Brand Name

Medline Industries, Inc.

Version/Model Number

DYNJGWIRE36

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"

-

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

DQX

Product Code Name

Wire, guide, catheter

Device Record Status

Public Device Record Key

882e2b1e-334e-4afd-88f9-7c154e27efa2

Public Version Date

August 12, 2022

Public Version Number

1

DI Record Publish Date

August 04, 2022

Additional Identifiers

Package DI Number

40889942860778

Quantity per Package

10

Contains DI Package

10889942860777

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