Medline Industries, Inc. - SJ DOUBLE BASIN SET-LF - MEDLINE INDUSTRIES, INC.

Duns Number:025460908

Device Description: SJ DOUBLE BASIN SET-LF

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More Product Details

Catalog Number

PHS619928002C

Brand Name

Medline Industries, Inc.

Version/Model Number

PHS619928002C

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

KDD

Product Code Name

Kit, surgical instrument, disposable

Device Record Status

Public Device Record Key

ec7886bb-672c-4ef8-aac3-b209bc63c4a2

Public Version Date

September 12, 2022

Public Version Number

1

DI Record Publish Date

September 04, 2022

Additional Identifiers

Package DI Number

40195327239351

Quantity per Package

5

Contains DI Package

10195327239350

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