Mediflex Laparoscopic Instruments - Suture Grasper Guides - Suture Passer Guide, 10mm x 11.2cm - FLEXBAR MACHINE CORPORATION

Duns Number:047644935

Device Description: Suture Passer Guide, 10mm x 11.2cm

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Mediflex Laparoscopic Instruments - Suture Grasper Guides

Version/Model Number

94415

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

-

Prescription Use (Rx)

-

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

FZX

Product Code Name

Guide, Surgical, Instrument

Device Record Status

Public Device Record Key

a68d8efe-0a82-49be-b100-432381c277a1

Public Version Date

March 04, 2019

Public Version Number

1

DI Record Publish Date

January 31, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"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