ENTRIPORT G3-R12GK

GUDID 30653405082464

Fascia Anchor Adapter Seal Replacement

Conmed Corporation

Laparoscopic access cannula anchor, reusable

• Primary Device ID: 30653405082464
• NIH Device Record Key: a7cd9fc5-d3c1-4ec0-bc5f-8c327f188a45
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENTRIPORT
• Version Model Number: G3-R12GK
• Catalog Number: G3-R12GK
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• 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	00653405082463 [Unit of Use]
GS1	10653405082460 [Package]; Contains: 20653405082467; Package: POUCH [10 Units]; In Commercial Distribution
GS1	20653405082467 [Primary]
GS1	30653405082464 [Direct Marking]

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: false

[30653405082464]

Moist Heat or Steam Sterilization

[30653405082464]

Moist Heat or Steam Sterilization

[30653405082464]

Moist Heat or Steam Sterilization

[30653405082464]

Moist Heat or Steam Sterilization

[30653405082464]

Moist Heat or Steam Sterilization

[30653405082464]

Moist Heat or Steam Sterilization

[30653405082464]

Moist Heat or Steam Sterilization

[30653405082464]

Moist Heat or Steam Sterilization

[30653405082464]

Moist Heat or Steam Sterilization

[30653405082464]

Moist Heat or Steam Sterilization

[30653405082464]

Moist Heat or Steam Sterilization

[30653405082464]

Moist Heat or Steam Sterilization

[30653405082464]

Moist Heat or Steam Sterilization

[30653405082464]

Moist Heat or Steam Sterilization

[30653405082464]

Moist Heat or Steam Sterilization

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

On-Brand Devices [ENTRIPORT]

• 40653405081907: BLADELESS OPTICAL TROCAR
• 40653405081891: Bladeless Mini Trocar
• 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
• 10653405082316: Reposable Bladeless Mini Trocar
• 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