SPROTTE® NRFit 331163-31B

GUDID 04048223066546

SPROTTE® NRFit 20G x 3 1/2" (90mm), with IntroDucer NRFit 30mm and wing

Pajunk GmbH Medizintechnologie

Spinal needle, single-use

• Primary Device ID: 04048223066546
• NIH Device Record Key: f8ffe3a8-6993-426c-9e61-2de03aeb01ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPROTTE® NRFit
• Version Model Number: 331163-31B
• Catalog Number: 331163-31B
• 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: 20 Gauge
• Length: 90 Millimeter
• Needle Gauge: 20 Gauge
• Length: 90 Millimeter
• Needle Gauge: 20 Gauge
• Length: 90 Millimeter
• Needle Gauge: 20 Gauge
• Length: 90 Millimeter
• Needle Gauge: 20 Gauge
• Length: 90 Millimeter
• Needle Gauge: 20 Gauge
• Length: 90 Millimeter
• Needle Gauge: 20 Gauge
• Length: 90 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	04048223066546 [Package]; Contains: 04048223087121; Package: [25 Units]; In Commercial Distribution
GS1	04048223087121 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160294

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

On-Brand Devices [SPROTTE® NRFit]

• 14048223031657: SPROTTE® NRFit 24G x 1 3/8" (35mm) sterile
• 14048223030353: SPROTTE® NRFit 27G x 4 ¾" (120mm) with IntroDu
• 14048223030346: SPROTTE® NRFit 27G x 3 ½" (90mm), with IntroDu
• 14048223030339: SPROTTE® NRFit 25G x 6" (150mm)
• 14048223030315: SPROTTE® NRFit 25G x 3 ½" (90mm), with IntroDu
• 14048223030308: SPROTTE® NRFit 24G x 8" (200mm) with IntroDuc
• 14048223030292: SPROTTE® NRFit 24G x 1" (25mm)
• 14048223030261: SPROTTE® NRFit 22G x 4" (103mm) with IntroDuc
• 14048223030254: SPROTTE® NRFit 22G x 3½" (90mm)
• 14048223029913: SPROTTE® NRFit 27G x 3 ½" (90mm) with IntroDu
• 14048223029821: SPROTTE® NRFit 24G x 3½" (90mm)
• 14048223027025: SPROTTE® NRFit 27G x 4 ¾" (120mm)
• 14048223027018: SPROTTE® NRFit 27G x 4" (103mm) with IntroDuc
• 14048223027001: SPROTTE® NRFit 25G x 6" (150mm) with IntroDuc
• 14048223026998: SPROTTE® NRFit 25G x 4 ¾" (120mm)
• 14048223026981: SPROTTE® NRFit 25G x 4 ¾" (120mm) with IntroDu
• 14048223026974: SPROTTE® NRFit 25G x 4" (103mm) with IntroDuc
• 14048223026967: SPROTTE® NRFit 25G x 3 ½" (90mm)
• 14048223026950: SPROTTE® NRFit 25G x 3 ½" (90mm) with IntroDu
• 14048223026943: SPROTTE® NRFit 25G x 1 3/8" (35mm)
• 14048223026936: SPROTTE® NRFit 24G x 6" (150mm) with IntroDuc
• 14048223026929: SPROTTE® NRFit 24G x 4 ¾" (120mm) with IntroDu
• 14048223026912: SPROTTE® NRFit 24G x 4" (103mm) with IntroDuc
• 14048223026905: SPROTTE® NRFit 24G x 3 ½" (90mm) with IntroDu
• 14048223026899: SPROTTE® NRFit 22G x 6" (150mm) with IntroDuc
• 14048223026882: SPROTTE® NRFit 22G x 4 ¾" (120mm) with IntroDu
• 14048223026875: SPROTTE® NRFit 22G x 3 ½" (90mm) with IntroDu
• 04048223066546: SPROTTE® NRFit 20G x 3 1/2" (90mm), with IntroDucer NRFit 30mm and wing