G3-12-CB

GUDID 10653405082019

Bladed Trocar

Conmed Corporation

Laparoscopic access cannula, single-use

• Primary Device ID: 10653405082019
• NIH Device Record Key: 231c8c1a-cd5c-4115-9850-010f1e2c2a2c
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: G3-12-CB
• Catalog Number: G3-12-CB
• Company DUNS: 071595540
• Company Name: Conmed Corporation
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Dimensions

• Width: 12 Millimeter
• Width: 12 Millimeter
• Width: 12 Millimeter
• Width: 12 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00653405082012 [Unit of Use]
GS1	10653405082019 [Package]; Contains: 20653405082016; Package: BOX [10 Units]; In Commercial Distribution
GS1	20653405082016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142464

FDA Product Code

• GCJ: Laparoscope, general & plastic surgery

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[10653405082019]

Ethylene Oxide

[10653405082019]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-09
• Device Publish Date: 2016-09-24

Devices Manufactured by Conmed Corporation

• 30845854045224 - CONMED: 2024-08-16 GAS WARMER
• 20845854650179 - Argo Knotless: 2024-08-16 4.75/5.5 mm Argo Knotless Disposable Smooth Punch
• 20845854650186 - Argo Knotless: 2024-08-16 4.75/5.5 mm Argo Knotless Disposable Tapered Broaching Punch
• 20845854650193 - Argo Knotless: 2024-08-16 4.75 mm Argo Knotless Disposable Tap
• 20845854650209 - Argo Knotless: 2024-08-16 5.5 mm Argo Knotless Disposable Tap
• 10653405988342 - Argo Knotless: 2024-08-16 5.5 mm Argo Knotless Reusable Tap
• 10653405988359 - Argo Knotless: 2024-08-16 4.75/5.5 mm Argo Knotless Reusable Smooth Punch
• 10653405988366 - Argo Knotless: 2024-08-16 4.75 mm Argo Knotless Reusable Tap