VCARE 60-6085-202A

GUDID 20653405003806

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

Conmed Corporation

Uterine manipulator, single-use

• Primary Device ID: 20653405003806
• NIH Device Record Key: d4ecfd7c-1460-43e0-9b5b-46b6e70e8cf2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VCARE
• Version Model Number: 60-6085-202A
• Catalog Number: 60-6085-202A
• 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: true
• 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

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
• 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	00653405003802 [Unit of Use]
GS1	10653405003809 [Primary]
GS1	20653405003806 [Package]; Contains: 10653405003809; Package: BOX [8 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142716

FDA Product Code

• LKF: Cannula, manipulator/injector, uterine

Sterilization

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

[20653405003806]

Ethylene Oxide

[20653405003806]

Ethylene Oxide

[20653405003806]

Ethylene Oxide

[20653405003806]

Ethylene Oxide

[20653405003806]

Ethylene Oxide

[20653405003806]

Ethylene Oxide

[20653405003806]

Ethylene Oxide

[20653405003806]

Ethylene Oxide

[20653405003806]

Ethylene Oxide

[20653405003806]

Ethylene Oxide

[20653405003806]

Ethylene Oxide

[20653405003806]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2024-08-02
• Device Publish Date: 2017-06-10

On-Brand Devices [VCARE]

• 20653405003813: VCARE EXTRA LARGE, UTERINE MANIPULATOR, VAGINAL-CERVICAL-AHLUWALIA'S-RETRACTOR-ELEVATOR
• 20653405003806: VCARE LARGE, UTERINE MANIPULATOR, VAGINAL-CERVICAL-AHLUWALIA'S-RETRACTOR-ELEVATOR
• 20653405003790: VCARE MEDIUM, UTERINE MANIPULATOR, VAGINAL-CERVICAL-AHLUWALIA'S-RETRACTOR-ELEVATOR
• 10653405003748: VCARE SMALL, UTERINE MANIPULATOR, VAGINAL-CERVICAL-AHLUWALIA'S-RETRACTOR-ELEVATOR