SonoTAP® II 1285-3Y050

GUDID 04048223057964

SonoTAP® II 24G x 50mm with bevel tip and Cornerstone Reflectors

Pajunk GmbH Medizintechnologie

Peripheral nerve-block sharp needle

• Primary Device ID: 04048223057964
• NIH Device Record Key: 6b32d223-eecc-4c8d-99af-249616e41fa4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SonoTAP® II
• Version Model Number: 1285-3Y050
• Catalog Number: 1285-3Y050
• Company DUNS: 317654283
• Company Name: Pajunk GmbH Medizintechnologie
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1 770-493-6832
• Email: info@pajunk-usa.com
• Phone: +1 770-493-6832
• Email: info@pajunk-usa.com
• Phone: +1 770-493-6832
• Email: info@pajunk-usa.com
• Phone: +1 770-493-6832
• Email: info@pajunk-usa.com
• Phone: +1 770-493-6832
• Email: info@pajunk-usa.com
• Phone: +1 770-493-6832
• Email: info@pajunk-usa.com
• Phone: +1 770-493-6832
• Email: info@pajunk-usa.com
• Phone: +1 770-493-6832
• Email: info@pajunk-usa.com

Device Dimensions

• Needle Gauge: 24 Gauge
• Length: 150 Millimeter
• Needle Gauge: 24 Gauge
• Length: 150 Millimeter
• Needle Gauge: 24 Gauge
• Length: 150 Millimeter
• Needle Gauge: 24 Gauge
• Length: 150 Millimeter
• Needle Gauge: 24 Gauge
• Length: 150 Millimeter
• Needle Gauge: 24 Gauge
• Length: 150 Millimeter
• Needle Gauge: 24 Gauge
• Length: 150 Millimeter

Operating and Storage Conditions

• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04048223057964 [Package]; Contains: 04048223078549; Package: [10 Units]; In Commercial Distribution
GS1	04048223078549 [Primary]

FDA Product Code

• BSP: NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-02-07
• Device Publish Date: 2025-01-30

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• 04048223126172 - SonoMSK: 2025-06-09 SonoMSK 22G x 90mm with Cornerstone Reflectors
• 04048223128114 - SPROTTE® NRFit: 2025-06-09 SPROTTE® NRFit 24G x 3 1/2" (90mm) with magnification and IntroDucer NRFit 30mm, sterile
• 04048223118702 - FixoLong: 2025-04-14 FixoLong Fixation system for Catheter and Filter
• 04048223120323 - Filter: 2025-04-14 Filter 0,2µm, sterile
• 04048223057650 - MonoBalloon DIL-XL: 2025-04-02 MonoBalloon DIL-XL Unilateral dilatation balloon Ø11mm round, Extra Large
• 04048223057704 - MonoBalloon URO: 2025-04-02 MonoBalloon URO URO ring-anchor balloon Ø 11mm, for extraperitoneal surgery
• 04048223072622 - EPISPIN II: 2025-02-10 EpiSpin II Tuohy with backeye and wings 18G x 90cm, Sprotte Standard