AccessGUDID - DEVICE: Ultimate Laparoscopic Suction Irrigation probe, reusable (05051223006046)

GUDID

Device Identifier (DI) Information

Brand Name: Ultimate Laparoscopic Suction Irrigation probe, reusable
Version or Model: PS3852ULT
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PS3852ULT
Company Name: PURPLE SURGICAL INTERNATIONAL LIMITED

Primary DI Number: 05051223006046
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 239403863 *Terms of Use

Device Description: The probe attached to the Laparoscopic Suction / Irrigation Set can be used during a variety of laparoscopic procedures to irrigate and remove fluid from the operating site, in the function of one instrument. The 10mm diameter probe is designed for use with the PS3850ULT & PS3851ULT suction irrigation sets. It is to be used in place of the standard 5mm diameter detachable probe which is originally supplied with the suction irrigation set, in instances where a 10mm probe provides surgical advantages.

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?
47625	Surgical irrigation/aspiration tubing set	A collection of flexible, noninvasive, double-lumen tubing and associated items intended to provide twin conduits in a surgical irrigation/aspiration system to deliver irrigation solution (e.g., saline) from its source (e.g., gravity feed bag) to a surgical cannula (not included) through one lumen, and provide aspiration (suction) through the other lumen (i.e., enables both irrigation and aspiration), during a surgical procedure (e.g., dental, laparoscopy). The tubing set includes devices such as clamps, filters, spikes, and Y-piece connectors, and may in addition include an integrated manual pump (e.g., a squeeze bulb) or handpiece. This is a single-use 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 [?]
Premarket Submission Number Not Available/Not Released

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
Ethylene Oxide
Radiation Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 333 Millimeter

Device Record Status

Public Device Record Key: 6c4e3321-c2c0-4ee9-afe4-e57dee9ceafb
Public Version Date: April 23, 2019
Public Version Number: 4
DI Record Publish Date: September 17, 2016