Epimed 296-DPA06X

GUDID 05060224334478

Adapter Assembly Disposable R-F™ Probe, Stryker Universal

MINTA MEDICAL LIMITED

Percutaneous electrosurgical probe, denervation, monopolar, single-use Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use

• Primary Device ID: 05060224334478
• NIH Device Record Key: 98f21826-b66d-43a0-bdc0-79b4c680b8b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Epimed
• Version Model Number: 296-DPA06X
• Catalog Number: 296-DPA06X
• Company DUNS: 232644059
• Company Name: MINTA MEDICAL LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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)866-3342
• Email: customerservice@epimed.com
• Phone: +1(800)866-3342
• Email: customerservice@epimed.com
• Phone: +1(800)866-3342
• Email: customerservice@epimed.com
• Phone: +1(800)866-3342
• Email: customerservice@epimed.com
• Phone: +1(800)866-3342
• Email: customerservice@epimed.com
• Phone: +1(800)866-3342
• Email: customerservice@epimed.com
• Phone: +1(800)866-3342
• Email: customerservice@epimed.com
• Phone: +1(800)866-3342
• Email: customerservice@epimed.com
• Phone: +1(800)866-3342
• Email: customerservice@epimed.com
• Phone: +1(800)866-3342
• Email: customerservice@epimed.com
• Phone: +1(800)866-3342
• Email: customerservice@epimed.com
• Phone: +1(800)866-3342
• Email: customerservice@epimed.com
• Phone: +1(800)866-3342
• Email: customerservice@epimed.com
• Phone: +1(800)866-3342
• Email: customerservice@epimed.com
• Phone: +1(800)866-3342
• Email: customerservice@epimed.com
• Phone: +1(800)866-3342
• Email: customerservice@epimed.com
• Phone: +1(800)866-3342
• Email: customerservice@epimed.com
• Phone: +1(800)866-3342
• Email: customerservice@epimed.com
• Phone: +1(800)866-3342
• Email: customerservice@epimed.com
• Phone: +1(800)866-3342
• Email: customerservice@epimed.com
• Phone: +1(800)866-3342
• Email: customerservice@epimed.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060224334478 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090608

FDA Product Code

• GXI: PROBE, RADIOFREQUENCY LESION

Sterilization

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

[05060224334478]

Ethylene Oxide

[05060224334478]

Ethylene Oxide

[05060224334478]

Ethylene Oxide

[05060224334478]

Ethylene Oxide

[05060224334478]

Ethylene Oxide

[05060224334478]

Ethylene Oxide

[05060224334478]

Ethylene Oxide

[05060224334478]

Ethylene Oxide

[05060224334478]

Ethylene Oxide

[05060224334478]

Ethylene Oxide

[05060224334478]

Ethylene Oxide

[05060224334478]

Ethylene Oxide

[05060224334478]

Ethylene Oxide

[05060224334478]

Ethylene Oxide

[05060224334478]

Ethylene Oxide

[05060224334478]

Ethylene Oxide

[05060224334478]

Ethylene Oxide

[05060224334478]

Ethylene Oxide

[05060224334478]

Ethylene Oxide

[05060224334478]

Ethylene Oxide

[05060224334478]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-08
• Device Publish Date: 2017-10-30

On-Brand Devices [Epimed]

• 05060224334584: Adapter Assembly Disposable R-F™ Probe, Baylis Ground
• 05060224334577: Adapter Assembly Disposable R-F™ Probe, Diros
• 05060224334560: Adapter Assembly Disposable R-F™ Probe, Baylis Intermediate
• 05060224334553: Adapter Assembly Disposable R-F™ Probe, Smith & Nephew
• 05060224334546: Adapter Assembly Disposable R-F™ Probe, Baylis
• 05060224334539: Adapter Assembly Disposable R-F™ Probe, Cosman
• 05060224334522: Adapter Assembly Disposable R-F™ Probe, Radionics
• 05060224334515: Adapter Assembly Disposable R-F™ Probe, Stryker, (150)
• 05060224334508: Adapter Assembly Disposable R-F™ Probe, Stryker, (100)
• 05060224334492: Adapter Assembly Disposable R-F™ Probe, Stryker, (50)
• 05060224334485: Adapter Assembly Disposable R-F™ Probe, Neurotherm
• 05060224334478: Adapter Assembly Disposable R-F™ Probe, Stryker Universal
• 05060224334461: Adapter Assembly R-F™ Probe, Stryker Universal
• 05060224333334: Adapter Assembly R-F™ Probe, Baylis as Ground
• 05060224333327: Adapter Assembly R-F™ Probe, Diros
• 05060224333310: Adapter Assembly R-F™ Probe, Stryker, 15cm
• 05060224333303: Adapter Assembly R-F™ Probe, Stryker, 10cm
• 05060224333297: Adapter Assembly R-F™ Probe, Stryker, 5cm
• 05060224333280: Adapter Assembly R-F™ Probe, Baylis Intermmediate
• 05060224333273: Adapter Assembly R-F™ Probe, Baylis
• 05060224333266: Adapter Assembly R-F™ Probe, Cosman
• 05060224333259: Adapter Assembly R-F™ Probe, Radionics
• 05060224333242: Adapter Assembly R-F™ Probe, Smith & Nephew
• 05060224333228: RF Probe Injection Port Disposable, 15cm
• 05060224333211: RF Probe Injection Port Disposable, 10cm
• 05060224333204: RF Probe Injection Port Disposable, 5cm
• 05060224333174: R-F™ Probe Disposable, 15cm
• 05060224333167: R-F™ Probe Disposable, 10cm
• 05060224333150: R-F™ Probe Disposable, 5cm
• 05060224333129: R-F™ Probe Assembly Minta, 15cm (Nitinol)
• 05060224333112: R-F™ Probe Assembly Minta, 10cm (Nitinol)
• 05060224333105: R-F™ Probe Assembly Minta, 5cm (Nitinol)
• 05060224333075: R-F™ Probe Assembly Minta, 15cm (Stainless Steel)
• 05060224333068: R-F™ Probe Assembly Minta, 10cm (Stainless Steel)
• 05060224333051: R-F™ Probe Assembly Minta, 5cm (Stainless Steel)