HK Tumescent Infiltration Cannula, (10cm) 4"-16 gauge, Single Use, Box of 10 - HK Tumescent Infiltration Cannula, (10cm) 4"-16 - HK SURGICAL INC.

Duns Number:106885259

Device Description: HK Tumescent Infiltration Cannula, (10cm) 4"-16 gauge, Single Use, Box of 10

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More Product Details

Catalog Number

SU-IC16x10

Brand Name

HK Tumescent Infiltration Cannula, (10cm) 4"-16 gauge, Single Use, Box of 10

Version/Model Number

SU-IC16x10

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

Yes

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

2a817a73-80e3-4e6d-890c-5186e8fd4008

Public Version Date

November 30, 2020

Public Version Number

1

DI Record Publish Date

November 20, 2020

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