Hayden Medical - 5mm Laparoscopic Knot Pusher (black handle), open - Hayden Medical, Inc.

Duns Number:618214410

Device Description: 5mm Laparoscopic Knot Pusher (black handle), open end, 32cm working length

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More Product Details

Catalog Number

HE13-1616O

Brand Name

Hayden Medical

Version/Model Number

HE13-1616O

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K974382

Product Code Details

Product Code

GCJ

Product Code Name

Laparoscope, general & plastic surgery

Device Record Status

Public Device Record Key

9d49f0c2-d3f1-494d-875a-ab1fe0069f68

Public Version Date

September 20, 2022

Public Version Number

1

DI Record Publish Date

September 12, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HAYDEN MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2893
2 A medical device with a moderate to high risk that requires special controls. 195