EXPOSE IU0010

GUDID 20653405037320

U-SHAPED 10MM X 41CM INFLATABLE RETRACTOR

Conmed Corporation

Laparoscopic blunt dissector

• Primary Device ID: 20653405037320
• NIH Device Record Key: b3778c02-7adf-47fd-a8a3-220a411cfe8c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXPOSE
• Version Model Number: IU0010
• Catalog Number: IU0010
• Company DUNS: 071595540
• Company Name: Conmed Corporation
• Device Count: 5
• 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

Device Dimensions

• Length: 41 Centimeter
• Outer Diameter: 10 Millimeter
• Length: 41 Centimeter
• Outer Diameter: 10 Millimeter
• Length: 41 Centimeter
• Outer Diameter: 10 Millimeter
• Length: 41 Centimeter
• Outer Diameter: 10 Millimeter
• Length: 41 Centimeter
• Outer Diameter: 10 Millimeter
• Length: 41 Centimeter
• Outer Diameter: 10 Millimeter
• Length: 41 Centimeter
• Outer Diameter: 10 Millimeter
• Length: 41 Centimeter
• Outer Diameter: 10 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00653405037326 [Unit of Use]
GS1	20653405037320 [Package]; Contains: 30653405037327; Package: BOX [5 Units]; In Commercial Distribution
GS1	30653405037327 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K933497

FDA Product Code

• GCJ: Laparoscope, general & plastic surgery

Sterilization

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

[20653405037320]

Ethylene Oxide

[20653405037320]

Ethylene Oxide

[20653405037320]

Ethylene Oxide

[20653405037320]

Ethylene Oxide

[20653405037320]

Ethylene Oxide

[20653405037320]

Ethylene Oxide

[20653405037320]

Ethylene Oxide

[20653405037320]

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

On-Brand Devices [EXPOSE]

• 30653405037488: Laparoscopic Retractor, flat kite
• 40653405037355: Laparoscopic Retractor, curved kite
• 40653405037331: Laparo,copic Retractor, angled flat kite
• 20653405037320: U-SHAPED 10MM X 41CM INFLATABLE RETRACTOR
• 20653405037313: TRIANGLE SHAPED 10MM X 41CM INFLATABLE RETRACTOR
• 30845854040373: AUTOCLAVABLE LIGHT GUIDE 5MM X 3M