IntroDucer NRFit 061163-30L

GUDID 04048223053867

IntroDucer NRFit 1,2 x 30mm for the Standard SPROTTE® NRFit 20G/21G

Pajunk GmbH Medizintechnologie

Needle guide, single-use

• Primary Device ID: 04048223053867
• NIH Device Record Key: fb6e87a9-e054-4934-8c38-f8bbba896cf5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IntroDucer NRFit
• Version Model Number: 061163-30L
• Catalog Number: 061163-30L
• Company DUNS: 317654283
• Company Name: Pajunk GmbH Medizintechnologie
• Device Count: 1
• 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: 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

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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04048223053867 [Package]; Contains: 04048223074442; Package: [25 Units]; In Commercial Distribution
GS1	04048223074442 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241953

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: 2025-07-07
• Device Publish Date: 2025-06-27

On-Brand Devices [IntroDucer NRFit]

• 14048223033897: IntroDucer NRFit 1,0 x 40mm for the Standard SPROT
• 14048223028800: IntroDucer NRFit 1,0 x 30mm for the Standard SPROT
• 14048223028794: IntroDucer NRFit 0,8 x 30mm for the Standard SPROT
• 04048223132173: IntroDucer NRFit 1,0 x 40mm for the Standard SPROTTE® cannula 22G
• 04048223132166: IntroDucer NRFit 1,0 x 30mm for the Standard SPROTTE® NRFit 22G
• 04048223129784: IntroDucer NRFit 0,8 x 30mm for the Standard Sprotte Kanüle 24G/25G/26G/27G
• 04048223053867: IntroDucer NRFit 1,2 x 30mm for the Standard SPROTTE® NRFit 20G/21G