Mediflex Medi-Clip - Medium Large Clips - 1 Cartridge/1 Pouch - FLEXBAR MACHINE CORPORATION

Duns Number:047644935

Device Description: Medium Large Clips - 1 Cartridge/1 Pouch

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More Product Details

Catalog Number

50120-ML

Brand Name

Mediflex Medi-Clip

Version/Model Number

50120-ML

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K091060,K091060,K091060

Product Code Details

Product Code

FZP

Product Code Name

Clip, Implantable

Device Record Status

Public Device Record Key

b197d6af-7220-4dd5-a574-6f3241593612

Public Version Date

February 05, 2021

Public Version Number

4

DI Record Publish Date

May 12, 2017

Additional Identifiers

Package DI Number

30842102105013

Quantity per Package

20

Contains DI Package

20842102105016

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"FLEXBAR MACHINE CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 882
2 A medical device with a moderate to high risk that requires special controls. 595