AccessGUDID - DEVICE: DETACHATIP (20653405061684)

GUDID

Device Identifier (DI) Information

Brand Name: DETACHATIP
Version or Model: 3-4304
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 3-4304
Company Name: Conmed Corporation

Primary DI Number: 20653405061684
Issuing Agency: GS1
Commercial Distribution End Date: February 26, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: DETACHATIP III SHAFT, MULTIPLE USE SCISSORS, CURVED MINI-METZENBAUM

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:	No
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?
61876	Open-surgery electrosurgical electrode, monopolar, reusable	An invasive, monopolar, electrical conductor intended to be attached to an electrosurgical 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 reusable 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 [?]
K123260	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
Storage Environment Temperature: between 10 and 32 Degrees Celsius
Handling Environment Temperature: between 60 and 80 Degrees Fahrenheit
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Storage Environment Temperature: between 50 and 90 Degrees Fahrenheit
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between 16 and 27 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 5 MM X 43 CM

Device Record Status

Public Device Record Key: 7dcc1918-731a-4e56-9d09-986af43088ef
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: January 03, 2017