Medline Industries, Inc. - RFT BREAST BIOPSY PACK - MEDLINE INDUSTRIES, INC.

Duns Number:025460908

Device Description: RFT BREAST BIOPSY PACK

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More Product Details

Catalog Number

DYNJ50677A

Brand Name

Medline Industries, Inc.

Version/Model Number

DYNJ50677A

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

FCG

Product Code Name

Biopsy needle

Device Record Status

Public Device Record Key

21a9dcc2-4b10-4690-a0e9-e1f5cac2d530

Public Version Date

June 17, 2022

Public Version Number

4

DI Record Publish Date

August 28, 2018

Additional Identifiers

Package DI Number

40889942743439

Quantity per Package

4

Contains DI Package

10889942743438

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