AccessGUDID - DEVICE: UNIVERSAL PLUS (30653405010832)

GUDID

Device Identifier (DI) Information

Brand Name: UNIVERSAL PLUS
Version or Model: 60-5274-944
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 60-5274-944
Company Name: Conmed Corporation

Primary DI Number: 30653405010832
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: UNIVERSAL PLUS LAPAROSCOPIC ELECTRODE WITH ESCHAR-RESISTANT COATING - SUCTION/IRRIGATION, NEEDLE 5 MM X 44 CM

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?
61875	Endoscopic electrosurgical electrode, monopolar, single-use	A sterile, invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a monopolar configuration (i.e., used with a patient contact return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It is available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece or housing and has no electrical or mechanical controls (e.g., does not include ring-handles); it is not intended for gas-enhanced electrosurgery. 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 [?]
K952204	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
Handling Environment Humidity: less than 85 Percent (%) Relative Humidity
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between -20 and 140 Degrees Fahrenheit
Handling Environment Temperature: between 16 and 27 Degrees Celsius
Handling Environment Temperature: between 60 and 80 Degrees Fahrenheit
Storage Environment Temperature: between 10 and 32 Degrees Celsius
Handling Environment Temperature: between -29 and 60 Degrees Celsius
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Storage Environment Temperature: between 50 and 90 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 5 Millimeter
Length: 44 Centimeter

Device Record Status

Public Device Record Key: 43c67e20-3deb-4b22-ab93-6688438e196c
Public Version Date: August 02, 2024
Public Version Number: 6
DI Record Publish Date: September 24, 2016