Medline - PACK,UNIVERSAL,STERILE - MEDLINE INDUSTRIES, INC.

Duns Number:025460908

Device Description: PACK,UNIVERSAL,STERILE

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More Product Details

Catalog Number

44741

Brand Name

Medline

Version/Model Number

44741

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

GCJ

Product Code Name

Laparoscope, general & plastic surgery

Device Record Status

Public Device Record Key

b71209f0-3416-42d7-9847-a1be1d40d4c8

Public Version Date

June 17, 2022

Public Version Number

5

DI Record Publish Date

October 14, 2016

Additional Identifiers

Package DI Number

40080196000747

Quantity per Package

10

Contains DI Package

10080196000746

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