SONOTAP II 1285-3Y040

GUDID 04048223078532

CornerStonesProximal End: ISO 80369-7

Pajunk GmbH Medizintechnologie

Peripheral nerve-block sharp needle

• Primary Device ID: 04048223078532
• NIH Device Record Key: cef1626d-5e97-4010-b43f-7fa60cfc1ef5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SONOTAP II
• Version Model Number: 1285-3Y040
• Catalog Number: 1285-3Y040
• Company DUNS: 317654283
• Company Name: Pajunk GmbH Medizintechnologie
• Device Count: 10
• 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: 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
• 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
• 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

• Outer Diameter: 0.55 Millimeter
• Length: 71 Millimeter
• Outer Diameter: 0.55 Millimeter
• Length: 71 Millimeter
• Outer Diameter: 0.55 Millimeter
• Length: 71 Millimeter
• Outer Diameter: 0.55 Millimeter
• Length: 71 Millimeter
• Outer Diameter: 0.55 Millimeter
• Length: 71 Millimeter
• Outer Diameter: 0.55 Millimeter
• Length: 71 Millimeter
• Outer Diameter: 0.55 Millimeter
• Length: 71 Millimeter
• Outer Diameter: 0.55 Millimeter
• Length: 71 Millimeter
• Outer Diameter: 0.55 Millimeter
• Length: 71 Millimeter
• Outer Diameter: 0.55 Millimeter
• Length: 71 Millimeter
• Outer Diameter: 0.55 Millimeter
• Length: 71 Millimeter
• Outer Diameter: 0.55 Millimeter
• Length: 71 Millimeter
• Outer Diameter: 0.55 Millimeter
• Length: 71 Millimeter
• Outer Diameter: 0.55 Millimeter
• Length: 71 Millimeter
• Outer Diameter: 0.55 Millimeter
• Length: 71 Millimeter
• Outer Diameter: 0.55 Millimeter
• Length: 71 Millimeter
• Outer Diameter: 0.55 Millimeter
• Length: 71 Millimeter
• Outer Diameter: 0.55 Millimeter
• Length: 71 Millimeter
• Outer Diameter: 0.55 Millimeter
• Length: 71 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04048223057957 [Primary]
GS1	04048223078532 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113207

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: 2021-07-27
• Device Publish Date: 2021-07-19

On-Brand Devices [SONOTAP II]

• 14048223033286: SonoTAP II 21G x 150mm wit bevel tip and Cornerstone Re
• 14048223033224: SonoTAP II 21G x 110mm with bevel tip and Cornerstone Re
• 14048223033217: SonoTAP II 22G x 80mm with bevel tip and Cornerstone Re
• 14048223033200: SonoTAP II 22G x 50mm with bevel tip and Cornerstone Re
• 04048223033289: 1285-3F150
• 04048223033227: 1285-3F110
• 04048223033210: 1285-3E080
• 04048223033203: 1285-3E050
• 04048223033838: 1265-3F110
• 04048223033821: 1265-3E080
• 04048223033814: 1265-3E050
• 04048223113486: 1285-3F150
• 04048223113479: 1285-3F110
• 04048223113462: 1285-3E080
• 04048223113455: 1285-3E050
• 04048223113448: 1265-3F110
• 04048223113431: 1265-3E080
• 04048223113424: 1265-3E050
• 04048223078532: CornerStonesProximal End: ISO 80369-7