AccessGUDID - DEVICE: HK Tumescent Infiltration Cannula, (27cm) 11"-12 gauge, Single Use, Box of 10 (00816989020898)

GUDID

Device Identifier (DI) Information

Brand Name: HK Tumescent Infiltration Cannula, (27cm) 11"-12 gauge, Single Use, Box of 10
Version or Model: SU-IC12x27
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SU-IC12x27
Company Name: HK SURGICAL INC.

Primary DI Number: 00816989020898
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 106885259 *Terms of Use

Device Description: HK Tumescent Infiltration Cannula, (27cm) 11"-12 gauge, Single Use, Box of 10

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
45414	Liposuction system cannula, reusable	A rigid tube that functions as a component of a lipectomy suction system and designed specifically for percutaneous insertion into body fat deposits for the aspiration of fat during liposuction/lipoplasty. The device may also be used to infiltrate the operative site with a solution during the procedure, which is then aspirated. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEA	Cannula, Surgical, General & Plastic Surgery

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ee0994f4-e935-498e-b00a-76c99d2c0449
Public Version Date: November 30, 2020
Public Version Number: 1
DI Record Publish Date: November 20, 2020