AccessGUDID - DEVICE: NA (30653405059473)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 2-4317
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 2-4317
Company Name: Conmed Corporation

Primary DI Number: 30653405059473
Issuing Agency: GS1
Commercial Distribution End Date: November 27, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: 5MM X 43CM MULTIPLE USE DISSECTOR, RIGHT ANGLE MEEKER

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 [?]
K924283	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

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

Device Record Status

Public Device Record Key: f1c902c7-8422-47a0-8797-edb0cfbdb1a6
Public Version Date: July 06, 2018
Public Version Number: 4
DI Record Publish Date: September 24, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: Yes
DM DI Number: 40653405059470
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)237-0169
Email: CUSTOMER_SERVICE@CONMED.COM

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES