AccessGUDID - DEVICE: SuperFlow Tubing Set with EndoSI Suction / Irrigator (10850082007087)

GUDID

Device Identifier (DI) Information

Brand Name: SuperFlow Tubing Set with EndoSI Suction / Irrigator
Version or Model: 21432
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ARMM INC.

Primary DI Number: 10850082007087
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 797391778 *Terms of Use

Device Description: Suction / Irrigation Probe with Wye Tubing Set

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?
47342	Laparoscopic irrigation/aspiration cannula	A rigid, sterile, hand-operated, tube-like device intended to be inserted through a laparoscopic port to provide a conduit for the instillation and/or aspiration of fluid during laparoscopy. It has a single-lumen, a proximal handle, and is typically made of plastic materials. It is connected via tubing to an appropriate irrigating/aspirating device(s), the irrigation/aspiration being regulated by the operator with mechanical valve controls typically in the handle of the cannula. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
GCJ	Laparoscope, General & Plastic Surgery

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K923201	000

Device Exempt from Premarket Submission: No 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: f3528458-5c9c-4594-b64f-0e1b15876397
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 24, 2016