G3-12-RCB

GUDID 10653405082255

Reposable Bladeless Trocar

Conmed Corporation

Laparoscopic surgical procedure kit, non-medicated, single-use

Primary Device ID	10653405082255
NIH Device Record Key	e4092e68-bdb3-424d-b544-ed89f6ade22f
Commercial Distribution Status	In Commercial Distribution
Version Model Number	G3-12-RCB
Catalog Number	G3-12-RCB
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
Phone	+1(800)237-0169
Email	CUSTOMER_SERVICE@CONMED.COM
Phone	+1(800)237-0169
Email	CUSTOMER_SERVICE@CONMED.COM
Phone	+1(800)237-0169
Email	CUSTOMER_SERVICE@CONMED.COM
Phone	+1(800)237-0169
Email	CUSTOMER_SERVICE@CONMED.COM
Phone	+1(800)237-0169
Email	CUSTOMER_SERVICE@CONMED.COM
Phone	+1(800)237-0169
Email	CUSTOMER_SERVICE@CONMED.COM
Phone	+1(800)237-0169
Email	CUSTOMER_SERVICE@CONMED.COM
Phone	+1(800)237-0169
Email	CUSTOMER_SERVICE@CONMED.COM
Phone	+1(800)237-0169
Email	CUSTOMER_SERVICE@CONMED.COM
Phone	+1(800)237-0169
Email	CUSTOMER_SERVICE@CONMED.COM
Phone	+1(800)237-0169
Email	CUSTOMER_SERVICE@CONMED.COM
Phone	+1(800)237-0169
Email	CUSTOMER_SERVICE@CONMED.COM
Phone	+1(800)237-0169
Email	CUSTOMER_SERVICE@CONMED.COM
Phone	+1(800)237-0169
Email	CUSTOMER_SERVICE@CONMED.COM
Phone	+1(800)237-0169
Email	CUSTOMER_SERVICE@CONMED.COM

Device Dimensions

Length	100 Millimeter
Width	12 Millimeter
Length	100 Millimeter
Width	12 Millimeter
Length	100 Millimeter
Width	12 Millimeter
Length	100 Millimeter
Width	12 Millimeter
Length	100 Millimeter
Width	12 Millimeter
Length	100 Millimeter
Width	12 Millimeter
Length	100 Millimeter
Width	12 Millimeter
Length	100 Millimeter
Width	12 Millimeter
Length	100 Millimeter
Width	12 Millimeter
Length	100 Millimeter
Width	12 Millimeter
Length	100 Millimeter
Width	12 Millimeter
Length	100 Millimeter
Width	12 Millimeter
Length	100 Millimeter
Width	12 Millimeter
Length	100 Millimeter
Width	12 Millimeter
Length	100 Millimeter
Width	12 Millimeter
Length	100 Millimeter
Width	12 Millimeter
Length	100 Millimeter
Width	12 Millimeter

Operating and Storage Conditions

Storage Environment Temperature	Between 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Temperature	Between 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Temperature	Between 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Temperature	Between 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Temperature	Between 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Temperature	Between 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Temperature	Between 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Temperature	Between 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Temperature	Between 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Temperature	Between 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Temperature	Between 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Temperature	Between 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Temperature	Between 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Temperature	Between 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Temperature	Between 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Temperature	Between 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Temperature	Between 10 Degrees Celsius and 32 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00653405082258 [Unit of Use]
GS1	10653405082255 [Package] Contains: 20653405082252 Package: BOX [10 Units] In Commercial Distribution
GS1	20653405082252 [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

[10653405082255]

Ethylene Oxide

[10653405082255]

Ethylene Oxide

[10653405082255]

Ethylene Oxide

[10653405082255]

Ethylene Oxide

[10653405082255]

Ethylene Oxide

[10653405082255]

Ethylene Oxide

[10653405082255]

Ethylene Oxide

[10653405082255]

Ethylene Oxide

[10653405082255]

Ethylene Oxide

[10653405082255]

Ethylene Oxide

[10653405082255]

Ethylene Oxide

[10653405082255]

Ethylene Oxide

[10653405082255]

Ethylene Oxide

[10653405082255]

Ethylene Oxide

[10653405082255]

Ethylene Oxide

[10653405082255]

Ethylene Oxide

[10653405082255]

Ethylene Oxide

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2016-09-24

Devices Manufactured by Conmed Corporation

10653405986362 - CONMED	2026-01-26 Universal Modular Base Cart
30653405986373 - CONMED	2026-01-26 Universal Modular Cart, Cord Wraps
20653405990182 - CONMED	2026-01-26 Universal Cart Strap
10653405990734 - Hall® Titan™	2026-01-06 Hall® Titan™ XE Single Trigger Battery Handpiece
10653405990741 - Hall® Titan™	2026-01-06 Hall® Titan™ XE Dual Trigger Battery Handpiece
30653405990714 - Infinity	2025-12-09 Infinity Retro-Reamer, 10.5 mm
30653405990707 - BioBrace	2025-11-25 BioBrace Extra-Articular Ligament Augmentation Kit
00810021867373 - CoLink®	2025-07-11 CoLink® Afx, Locking Screw, 2.7X14.0MM, 2-Pack