AccessGUDID - DEVICE: Speedboat RS2 8 Fr Instrument (05060359560575)

GUDID

Device Identifier (DI) Information

Brand Name: Speedboat RS2 8 Fr Instrument
Version or Model: 7-RS2-003
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7-RS2-003
Company Name: CREO MEDICAL LIMITED

Primary DI Number: 05060359560575
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 733853373 *Terms of Use

Device Description: A sterile, flexible, invasive, endoscopic device assembly intended to deliver: 1) a submucosal lifting solution; 2) an electrosurgical current in a bipolar configuration to tissues for cutting; and 3) microwave energy to tissues for coagulation. It is typically intended to treat gastrointestinal mucosal polyps/lesions through lifting of the diseased mucosa over a bubble of fluid, and subsequent electrosurgical excision of the diseased area. It includes a submucosal injection needle, an electrosurgical electrode, and a microwave tip, connected by a flexible sheath to a handpiece which includes controls (e.g., needle deployment control)/solution injection port. This is a single-use device.

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?
63397	Endoscopic electrosurgical/microwave submucosal lift/resection instrument	A flexible, invasive, endoscopic device assembly intended to deliver: 1) a submucosal lifting solution; 2) an electrosurgical current in a bipolar configuration to tissues for cutting; and 3) microwave energy to tissues for coagulation. It is typically intended to treat gastrointestinal mucosal polyps/lesions through lifting of the diseased mucosa over a bubble of fluid, and subsequent electrosurgical excision of the diseased area. It includes a lift solution delivery needle or lumen, an electrosurgical electrode, and a microwave tip, connected by a flexible sheath to a handpiece which includes controls (e.g., needle deployment control)/solution injection port. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K171983	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
Handling Environment Temperature: between 10 and 30 Degrees Celsius
Handling Environment Humidity: between 20 and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 69 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 2.65 Millimeter
Catheter Length: 2.3 Meter

Device Record Status

Public Device Record Key: 6c6b920e-4b09-4ad5-bd78-c7d78f0d5441
Public Version Date: December 18, 2023
Public Version Number: 2
DI Record Publish Date: November 08, 2023