MEDLINE - M04272B STERILE CLAMSHELL SMALL - MEDLINE INDUSTRIES, INC.

Duns Number:025460908

Device Description: M04272B STERILE CLAMSHELL SMALL

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More Product Details

Catalog Number

DYNDA2905

Brand Name

MEDLINE

Version/Model Number

DYNDA2905

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

LRO

Product Code Name

General surgery tray

Device Record Status

Public Device Record Key

e6e7fc85-3398-4b14-bd89-333d2fa7832f

Public Version Date

May 03, 2022

Public Version Number

1

DI Record Publish Date

April 25, 2022

Additional Identifiers

Package DI Number

00653160352702

Quantity per Package

30

Contains DI Package

10653160352709

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