AccessGUDID - DEVICE: BEAMER (20653405064197)

GUDID

Device Identifier (DI) Information

Brand Name: BEAMER
Version or Model: BEAMSNARE-4
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BEAMSNARE-4
Company Name: Conmed Corporation

Primary DI Number: 20653405064197
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: BEAMER ARGON SNARE PROBE Dual mode probe for flexible endoscopy, 15 mm Oval, Monofilament Firm Wire Loop, 2.5 mm x 230cm

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":	Yes
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?
61878	Inert gas-enhanced endoscopic electrosurgical electrode, single-use	An invasive, distal component of an inert gas-enhanced electrosurgical system intended to deliver electrosurgical current within a stream of inert gas [e.g., argon (Ar), helium (He)] directly to tissues for cutting/coagulation/ablation during an endoscopic (including laparoscopic, arthroscopic) surgical procedure. It is a long thin device with no controls, typically designed as a coaxial arrangement of a monopolar electrode within a gas delivery tube/sleeve, which requires a patient contact return electrode to complete the circuit. It is available in a variety of forms (e.g., rigid laparoscopic electrode, flexible endoscopic probe). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEI	ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K081580	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
Special Storage Condition, Specify: KEEP AWAY FROM SUNLIGHT
Storage Environment Temperature: between 4.4 and 49 Degrees Celsius
Storage Environment Humidity: between 10 and 70 Percent (%) Relative Humidity
Special Storage Condition, Specify: KEEP DRY
Storage Environment Temperature: between 40 and 120 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Width: 2.5 Millimeter
Length: 230 Centimeter

Device Record Status

Public Device Record Key: 454d25d6-e652-48ec-87e9-6ad90ccbc857
Public Version Date: April 10, 2024
Public Version Number: 6
DI Record Publish Date: September 24, 2016