MEDLINE - STERILE FCP ROCH PEAN CVD 8' - MEDLINE INDUSTRIES, INC.

Duns Number:025460908

Device Description: STERILE FCP ROCH PEAN CVD 8'

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More Product Details

Catalog Number

DYND04181

Brand Name

MEDLINE

Version/Model Number

DYND04181

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

GEN

Product Code Name

FORCEPS, GENERAL & PLASTIC SURGERY

Device Record Status

Public Device Record Key

3b4095e4-77b3-4824-ab7e-285372aa8c86

Public Version Date

January 10, 2022

Public Version Number

1

DI Record Publish Date

January 01, 2022

Additional Identifiers

Package DI Number

40889942325901

Quantity per Package

50

Contains DI Package

10889942325900

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