AccessGUDID - DEVICE: X-Stream (00801741010095)

GUDID

Device Identifier (DI) Information

Brand Name: X-Stream
Version or Model: 5552002
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 5552002
Company Name: Davol Inc.

Primary DI Number: 00801741010095
Issuing Agency: GS1
Commercial Distribution End Date: February 28, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 001191048 *Terms of Use

Device Description: X-Stream Laparoscopic Irrigation Tubing Set with Nezhat-Dorsey Trumpet Valve, 5mm x 33cm Probe Tip with Holes and Cojoined Suction/Irrigation Tubing

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?
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)
GCJ	Laparoscope, general & plastic surgery

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: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 33 Centimeter
Circumference: 5 Millimeter

Device Record Status

Public Device Record Key: 251c1c72-4fd6-45e2-a1ee-63f19643832d
Public Version Date: February 28, 2025
Public Version Number: 5
DI Record Publish Date: December 23, 2015