AccessGUDID - DEVICE: Arthrex® (00888867100817)

GUDID

Device Identifier (DI) Information

Brand Name: Arthrex®
Version or Model: AR-3290-0001
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: AR-3290-0001
Company Name: ARTHREX, INC.

Primary DI Number: 00888867100817
Issuing Agency: GS1
Commercial Distribution End Date: June 25, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 131747628 *Terms of Use

Device Description: SYNERGY INSUF(ENGL ,GERM,FRENCH,SPANISH)

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?
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 [?]
K030837	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: 70c28119-dbd1-4363-a6f3-9fb1d5cf87c4
Public Version Date: August 29, 2024
Public Version Number: 8
DI Record Publish Date: February 15, 2017