AccessGUDID - DEVICE: MICTEC INJECTION CANNULA (B09920941010)

GUDID

Device Identifier (DI) Information

Brand Name: MICTEC INJECTION CANNULA
Version or Model: 20941-01
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: SONTEC INSTRUMENTS, INC.

Primary DI Number: B09920941010
Issuing Agency: HIBCC
Commercial Distribution End Date: September 23, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 040729840 *Terms of Use

Device Description: MICTEC INJECTION CANNULA CURVED SMALL LUER LOCK G22

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:	No
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?
37148	Laparoscopic access cannula, reusable	A single-lumen surgical device intended to be percutaneously inserted through the abdominal wall to create an access port for a laparoscope/laparoscopic instrument during laparoscopy. The cannula is often provided with a shut-off valve for gas/fluid supply, and other sealing devices (e.g., dedicated seals/rings, caps, valves), to prevent insufflation gas leakage whilst allowing entry of instruments. It may include a sharp or blunt trocar blade to assist introduction and/or puncture the abdominal wall; if the trocar is included it may be referred to as a trocar or trocar assembly. It is available in a variety of dimensions and/or designs. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HET	Laparoscope, Gynecologic (And Accessories)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K002877	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Dry Heat Sterilization
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 5mm Diameter
Device Size Text, specify: 30° Jaw
Length: 300 Millimeter

Device Record Status

Public Device Record Key: 7175d022-94f0-4cf2-9ce9-2862dc0bbda9
Public Version Date: September 24, 2018
Public Version Number: 7
DI Record Publish Date: September 30, 2016