AccessGUDID - DEVICE: TROGARD FINESSE (30653405012034)

GUDID

Device Identifier (DI) Information

Brand Name: TROGARD FINESSE
Version or Model: 60-6050-206
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 60-6050-206
Company Name: Conmed Corporation

Primary DI Number: 30653405012034
Issuing Agency: GS1
Commercial Distribution End Date: June 07, 2022
Device Count: 6
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: TROGARD FINESSE DILATING CONICAL BLUNT TIP LAPAROSCOPIC ACCESS SYESTEM, 5MM

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?
38559	Insufflation gas conditioning tubing set	A collection of sterile and non-sterile devices intended to be used with an insufflation gas conditioning system and/or a laparoscopic gas distention system, or other gas source, to condition the insufflation gas stream [typically carbon dioxide (CO2)] by heating and humidifying it before introduction into the peritoneal cavity or a wound during laparoscopic or open surgery. It is available in various configurations but typically includes a connection tube for connection to the gas source, an electrically-heated tube for transport of the conditioned gas to the operative site, a humidification chamber, a gas filter, and connectors. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HIF	INSUFFLATOR, LAPAROSCOPIC

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 50 and 90 Degrees Fahrenheit
Storage Environment Temperature: between 10 and 32 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Dilating Conical Blunt Tip

Device Record Status

Public Device Record Key: 0c0b130f-95db-480d-ab17-898ccd250549
Public Version Date: June 08, 2022
Public Version Number: 3
DI Record Publish Date: September 24, 2016