ENTRIPORT G3-M05SN-NB

GUDID 10653405082354

Bladeless Mini Trocar without Stopcock

Conmed Corporation

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

Primary Device ID	10653405082354
NIH Device Record Key	6628ad98-d45c-4f0f-bbee-2bfa66875686
Commercial Distribution Status	In Commercial Distribution
Brand Name	ENTRIPORT
Version Model Number	G3-M05SN-NB
Catalog Number	G3-M05SN-NB
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

Width	5 Millimeter
Length	70 Millimeter
Width	5 Millimeter
Length	70 Millimeter
Width	5 Millimeter
Length	70 Millimeter
Width	5 Millimeter
Length	70 Millimeter
Width	5 Millimeter
Length	70 Millimeter
Width	5 Millimeter
Length	70 Millimeter
Width	5 Millimeter
Length	70 Millimeter
Width	5 Millimeter
Length	70 Millimeter
Width	5 Millimeter
Length	70 Millimeter
Width	5 Millimeter
Length	70 Millimeter
Width	5 Millimeter
Length	70 Millimeter
Width	5 Millimeter
Length	70 Millimeter
Width	5 Millimeter
Length	70 Millimeter
Width	5 Millimeter
Length	70 Millimeter
Width	5 Millimeter
Length	70 Millimeter
Width	5 Millimeter
Length	70 Millimeter
Width	5 Millimeter
Length	70 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	00653405082357 [Unit of Use]
GS1	10653405082354 [Package] Contains: 20653405082351 Package: BOX [10 Units] In Commercial Distribution
GS1	20653405082351 [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

[10653405082354]

Ethylene Oxide

[10653405082354]

Ethylene Oxide

[10653405082354]

Ethylene Oxide

[10653405082354]

Ethylene Oxide

[10653405082354]

Ethylene Oxide

[10653405082354]

Ethylene Oxide

[10653405082354]

Ethylene Oxide

[10653405082354]

Ethylene Oxide

[10653405082354]

Ethylene Oxide

[10653405082354]

Ethylene Oxide

[10653405082354]

Ethylene Oxide

[10653405082354]

Ethylene Oxide

[10653405082354]

Ethylene Oxide

[10653405082354]

Ethylene Oxide

[10653405082354]

Ethylene Oxide

[10653405082354]

Ethylene Oxide

[10653405082354]

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

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30653405082471	Reusable Open Entry (Hassan) Obturator
30653405082464	Fascia Anchor Adapter Seal Replacement
30653405082457	Reusable Fascia Anchor Adapter
30653405082440	Reusable Cannula
30653405082433	Reusable Cannula
30653405082426	Reusable Cannula
30653405082419	Reusable Mini cannula
30653405082402	Reusable Mini cannula
30653405082396	Reusable Mini Cannula without Stopcock
10653405082385	Mini seal Cap, Stopcock
10653405082378	Reposable Bladeless Mini Trocar
10653405082361	Reposable Bladeless Mini Trocar
10653405082354	Bladeless Mini Trocar without Stopcock
10653405082347	Bladed Mini Trocar without Stopcock
10653405082330	Mini Cannula Sleeve
10653405082323	Bladed Mini Trocar
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10653405082309	Reposable Bladed Mini Trocar
10653405082293	Bladeless Mini Trocar
10653405082286	Mini Cannula Sleeve
10653405082057	Bladed Mini Trocar
10653405082040	Seal Body, Stopcock
20653405005213	Bladeless Mini Trocar
20653405081897	Bladeless Mini Trocar
00653405082463	Fascia Anchor Adapter Seal Replacement