RSG-14F-4 - Suture Grasper Closure Device - FLEXBAR MACHINE CORPORATION

Duns Number:047644935

Device Description: Suture Grasper Closure Device

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More Product Details

Catalog Number

76021-01M

Brand Name

RSG-14F-4

Version/Model Number

D1001

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)

-

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

HCF

Product Code Name

Instrument, Ligature Passing And Knot Tying

Device Record Status

Public Device Record Key

31adbe7a-5598-4cfe-acdc-a0d7fd4775c6

Public Version Date

December 04, 2020

Public Version Number

5

DI Record Publish Date

November 11, 2016

Additional Identifiers

Package DI Number

10842102105040

Quantity per Package

10

Contains DI Package

00842102105043

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"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