NerveStim Pure 1151-94-90

GUDID 04048223126103

NerveStim Pure in transport case, incl. batteries

Pajunk GmbH Medizintechnologie

Nerve-locating system

• Primary Device ID: 04048223126103
• NIH Device Record Key: 940864f1-5948-4b71-a26e-ac4611767cd4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NerveStim Pure
• Version Model Number: 1151-94-90
• Catalog Number: 1151-94-90
• 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: false
• Lot Batch: true
• 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: 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

Operating and Storage Conditions

• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04048223126103 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162086

FDA Product Code

• BXN: STIMULATOR, NERVE, BATTERY-POWERED

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: 2026-02-16
• Device Publish Date: 2026-02-06

Devices Manufactured by Pajunk GmbH Medizintechnologie

• 04048223126103 - NerveStim Pure: 2026-02-16NerveStim Pure in transport case, incl. batteries
• 04048223126103 - NerveStim Pure: 2026-02-16 NerveStim Pure in transport case, incl. batteries
• 04048223128817 - SPROTTE®: 2025-09-25 SPROTTE® 25G x 3 1/2" (90mm) with magnification and Introducer, sterile
• 04048223129111 - SPROTTE® NRFit: 2025-09-25 SPROTTE® NRFit 25G x 4 3/4" (120mm) with magnification and IntroDucer NRFit 40mm, sterile
• 04048223129517 - SPROTTE® NRFit: 2025-09-25 SPROTTE® NRFit 25G x 4" (103mm) with magnification and IntroDucer NRFit 40mm, sterile
• 04048223129647 - SPROTTE®: 2025-09-25 SPROTTE® 22G x 2" (50mm), sterile
• 04048223129678 - SPROTTE® NRFit: 2025-09-25 SPROTTE® NRFit 22G x 3 1/2" (90mm) with magnification and IntroDucer NRFit 30mm, sterile
• 04048223129692 - SPROTTE® NRFit: 2025-09-25 SPROTTE® NRFit 27G x 4 3/4" (120mm) with magnification and IntroDucer NRFit 40mm, sterile
• 04048223129838 - SPROTTE® NRFit: 2025-09-25 SPROTTE® NRFit 25G x 6" (150mm) with magnification and IntroDucer NRFit 40mm, sterile