Epimed International, Inc. 233-2005

GUDID 10818788021431

RF™ Coudé® B Bevel 20g x 5cm with 10mm Active Tip

EPIMED INTERNATIONAL, INC

Radio-frequency ablation system probe cannula, single-use

• Primary Device ID: 10818788021431
• NIH Device Record Key: c07e9e72-67ec-42f5-a4c4-681dab4e5fa6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Epimed International, Inc.
• Version Model Number: 233-2005
• Catalog Number: 233-2005
• Company DUNS: 799751953
• Company Name: EPIMED INTERNATIONAL, INC
• 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

Device Dimensions

• Device Size Text, specify: 0
• Length: 15 Millimeter
• Length: 10 Centimeter
• Device Size Text, specify: 0
• Needle Gauge: 20 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Length: 10 Centimeter
• Device Size Text, specify: 0
• Needle Gauge: 20 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Length: 10 Centimeter
• Device Size Text, specify: 0
• Needle Gauge: 20 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Length: 10 Centimeter
• Device Size Text, specify: 0
• Needle Gauge: 20 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Length: 10 Centimeter
• Device Size Text, specify: 0
• Needle Gauge: 20 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Length: 10 Centimeter
• Device Size Text, specify: 0
• Needle Gauge: 20 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Length: 10 Centimeter
• Device Size Text, specify: 0
• Needle Gauge: 20 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Length: 10 Centimeter
• Device Size Text, specify: 0
• Needle Gauge: 20 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Length: 10 Centimeter
• Device Size Text, specify: 0
• Needle Gauge: 20 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Length: 10 Centimeter
• Device Size Text, specify: 0
• Needle Gauge: 20 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Length: 10 Centimeter
• Device Size Text, specify: 0
• Needle Gauge: 20 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Length: 10 Centimeter
• Device Size Text, specify: 0
• Needle Gauge: 20 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Length: 10 Centimeter
• Device Size Text, specify: 0
• Needle Gauge: 20 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Length: 10 Centimeter
• Device Size Text, specify: 0
• Needle Gauge: 20 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Length: 10 Centimeter
• Device Size Text, specify: 0
• Needle Gauge: 20 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Length: 10 Centimeter
• Device Size Text, specify: 0
• Needle Gauge: 20 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Length: 10 Centimeter
• Device Size Text, specify: 0
• Needle Gauge: 20 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Length: 10 Centimeter
• Device Size Text, specify: 0
• Needle Gauge: 20 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 15 Millimeter
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• Device Size Text, specify: 0
• Needle Gauge: 20 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Length: 10 Centimeter
• Device Size Text, specify: 0
• Needle Gauge: 20 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Length: 10 Centimeter
• Device Size Text, specify: 0
• Needle Gauge: 20 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Length: 10 Centimeter
• Device Size Text, specify: 0
• Needle Gauge: 20 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Length: 10 Centimeter
• Device Size Text, specify: 0
• Needle Gauge: 20 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Length: 10 Centimeter
• Device Size Text, specify: 0
• Needle Gauge: 20 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Length: 10 Centimeter
• Device Size Text, specify: 0
• Needle Gauge: 20 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Length: 10 Centimeter
• Device Size Text, specify: 0
• Needle Gauge: 20 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Length: 10 Centimeter
• Device Size Text, specify: 0
• Needle Gauge: 20 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Length: 10 Centimeter
• Device Size Text, specify: 0
• Needle Gauge: 20 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Length: 10 Centimeter
• Device Size Text, specify: 0
• Needle Gauge: 20 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Length: 10 Centimeter
• Device Size Text, specify: 0
• Needle Gauge: 20 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Length: 10 Centimeter
• Device Size Text, specify: 0
• Needle Gauge: 20 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Length: 10 Centimeter
• Device Size Text, specify: 0
• Needle Gauge: 20 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Length: 10 Centimeter
• Device Size Text, specify: 0
• Needle Gauge: 20 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Length: 10 Centimeter
• Device Size Text, specify: 0
• Needle Gauge: 20 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Length: 10 Centimeter
• Device Size Text, specify: 0
• Needle Gauge: 20 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Length: 10 Centimeter
• Device Size Text, specify: 0
• Needle Gauge: 20 Gauge
• Device Size Text, specify: 0

Operating and Storage Conditions

• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818788021434 [Primary]
GS1	10818788021431 [Package]; Contains: 00818788021434; Package: Case [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041021

FDA Product Code

• GXI: Probe, radiofrequency lesion

Sterilization

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

[10818788021431]

Ethylene Oxide

[10818788021431]

Ethylene Oxide

[10818788021431]

Ethylene Oxide

[10818788021431]

Ethylene Oxide

[10818788021431]

Ethylene Oxide

[10818788021431]

Ethylene Oxide

[10818788021431]

Ethylene Oxide

[10818788021431]

Ethylene Oxide

[10818788021431]

Ethylene Oxide

[10818788021431]

Ethylene Oxide

[10818788021431]

Ethylene Oxide

[10818788021431]

Ethylene Oxide

[10818788021431]

Ethylene Oxide

[10818788021431]

Ethylene Oxide

[10818788021431]

Ethylene Oxide

[10818788021431]

Ethylene Oxide

[10818788021431]

Ethylene Oxide

[10818788021431]

Ethylene Oxide

[10818788021431]

Ethylene Oxide

[10818788021431]

Ethylene Oxide

[10818788021431]

Ethylene Oxide

[10818788021431]

Ethylene Oxide

[10818788021431]

Ethylene Oxide

[10818788021431]

Ethylene Oxide

[10818788021431]

Ethylene Oxide

[10818788021431]

Ethylene Oxide

[10818788021431]

Ethylene Oxide

[10818788021431]

Ethylene Oxide

[10818788021431]

Ethylene Oxide

[10818788021431]

Ethylene Oxide

[10818788021431]

Ethylene Oxide

[10818788021431]

Ethylene Oxide

[10818788021431]

Ethylene Oxide

[10818788021431]

Ethylene Oxide

[10818788021431]

Ethylene Oxide

[10818788021431]

Ethylene Oxide

[10818788021431]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-04-20
• Device Publish Date: 2022-04-12

On-Brand Devices [Epimed International, Inc.]

• 10818788020410: RF™ Coudé® Blunt 20g TW x 10cm with 15mm Active Tip
• 10818788021431: RF™ Coudé® B Bevel 20g x 5cm with 10mm Active Tip
• 10818788020540: Plastic L.O.R./ 18g x 3.5" Tuohy
• 10818788023695: Percutaneous Introducer w/ 14g RW x 2.75" B Bevel needle with sidearm injection port and hemosta
• 10818788021509: Plastic L.O.R./ 22g x 3.5" Tuohy
• 10818788021486: Plastic L.O.R./ 20g x 3.5" Tuohy