OPTABLATE 9700-000-000

GUDID 07613327547610

RF GENERATOR

STRYKER CORPORATION

Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator

• Primary Device ID: 07613327547610
• NIH Device Record Key: 2ce4403e-b6f8-461c-bcbe-6bf69e04b3cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OPTABLATE
• Version Model Number: 9700000000
• Catalog Number: 9700-000-000
• Company DUNS: 196548481
• Company Name: STRYKER CORPORATION
• Device Count: 1
• 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: false
• Serial Number: true
• 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)253-3210
• Email: INST.STRYKER.CS@STRYKER.COM
• Phone: +1(800)253-3210
• Email: INST.STRYKER.CS@STRYKER.COM
• Phone: +1(800)253-3210
• Email: INST.STRYKER.CS@STRYKER.COM
• Phone: +1(800)253-3210
• Email: INST.STRYKER.CS@STRYKER.COM
• Phone: +1(800)253-3210
• Email: INST.STRYKER.CS@STRYKER.COM
• Phone: +1(800)253-3210
• Email: INST.STRYKER.CS@STRYKER.COM
• Phone: +1(800)253-3210
• Email: INST.STRYKER.CS@STRYKER.COM
• Phone: +1(800)253-3210
• Email: INST.STRYKER.CS@STRYKER.COM
• Phone: +1(800)253-3210
• Email: INST.STRYKER.CS@STRYKER.COM
• Phone: +1(800)253-3210
• Email: INST.STRYKER.CS@STRYKER.COM
• Phone: +1(800)253-3210
• Email: INST.STRYKER.CS@STRYKER.COM
• Phone: +1(800)253-3210
• Email: INST.STRYKER.CS@STRYKER.COM
• Phone: +1(800)253-3210
• Email: INST.STRYKER.CS@STRYKER.COM
• Phone: +1(800)253-3210
• Email: INST.STRYKER.CS@STRYKER.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327547610 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221074

FDA Product Code

• GEI: Electrosurgical, cutting & coagulation & accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-03
• Device Publish Date: 2022-09-23

On-Brand Devices [OPTABLATE]

• 07613327547610: RF GENERATOR
• 07613327524505: 150MM Temperature Sensor
• 07613327524482: 20 mm Probe Single Kit
• 07613327524475: 15MM Probe Single Kit
• 07613327524512: 15 mm Probe Dual Kit
• 07613327524499: 20 mm Probe Dual Kit
• 37613327591553: 11G HAND DRILL PACK