HK Finesse Microcannula, 3"-16 gauge - HK Finesse Microcannula, 3"-16 gauge - HK SURGICAL INC.

Duns Number:106885259

Device Description: HK Finesse Microcannula, 3"-16 gauge

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More Product Details

Catalog Number

HK16F8

Brand Name

HK Finesse Microcannula, 3"-16 gauge

Version/Model Number

HK16F8

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

-

Product Code Details

Product Code

GEA

Product Code Name

Cannula, Surgical, General & Plastic Surgery

Device Record Status

Public Device Record Key

efe5e211-192f-4030-b52e-33c852274aa1

Public Version Date

February 21, 2019

Public Version Number

3

DI Record Publish Date

June 25, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HK SURGICAL INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 77
2 A medical device with a moderate to high risk that requires special controls. 12