AccessGUDID - DEVICE: ULTRACLEAN (20653405034770)

GUDID

Device Identifier (DI) Information

Brand Name: ULTRACLEAN
Version or Model: 139112EXT
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 139112EXT
Company Name: Conmed Corporation

Primary DI Number: 20653405034770
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: UltraClean Accessory Electrode 4" (10.16 cm) Coated Blade with Extended Insulation

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?
61874	Open-surgery electrosurgical electrode, monopolar, single-use	An invasive, monopolar, electrical conductor intended to be attached to an appropriate handle/handpiece (not included) to deliver electrosurgical current directly to tissues for cutting/coagulation during an open surgical procedure. It may be available in a variety of forms (e.g., blade, ball, loop, needle, spatula) and requires a patient contact return electrode to complete the circuit. This is a single-use device intended to be used in a sterile condition.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEI	ELECTROSURGICAL, CUTTING & COAGULATION & 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: 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: 4 Inch

Device Record Status

Public Device Record Key: 85e908df-f485-486f-bc22-d56eb5c3409f
Public Version Date: August 02, 2024
Public Version Number: 4
DI Record Publish Date: September 24, 2016