VCARE EXTRA LARGE 60-6085-203

GUDID 20653405061820

VCARE EXTRA LARGE VAGINAL-CERVICAL-AHLUWALIA'S-RETRACTOR-ELEVATOR, UTERINE MANIPULATOR

Conmed Corporation

Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use

• Primary Device ID: 20653405061820
• NIH Device Record Key: e8a14aff-b342-490c-928a-723a7c070340
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VCARE EXTRA LARGE
• Version Model Number: 60-6085-203
• Catalog Number: 60-6085-203
• Company DUNS: 071595540
• Company Name: Conmed Corporation
• Device Count: 8
• 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

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 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00653405061826 [Unit of Use]
GS1	20653405061820 [Package]; Contains: 30653405061827; Package: BOX [8 Units]; In Commercial Distribution
GS1	30653405061827 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071907

FDA Product Code

• LKF: CANNULA, MANIPULATOR/INJECTOR, UTERINE

Sterilization

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

[20653405061820]

Ethylene Oxide

[20653405061820]

Ethylene Oxide

[20653405061820]

Ethylene Oxide

[20653405061820]

Ethylene Oxide

[20653405061820]

Ethylene Oxide

[20653405061820]

Ethylene Oxide

[20653405061820]

Ethylene Oxide

[20653405061820]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-12-07
• Device Publish Date: 2016-09-24

On-Brand Devices [VCARE EXTRA LARGE]

• 20653405082092: VCARE EXTRA LARGE VAGINAL-CERVICAL-AHLUWALIA'S-RETRACTOR-ELEVATOR, UTERINE MANIPULATOR
• 20653405061820: VCARE EXTRA LARGE VAGINAL-CERVICAL-AHLUWALIA'S-RETRACTOR-ELEVATOR, UTERINE MANIPULATOR