EpiSpin Lock 0021351-18

GUDID 04048223133385

EpiSpin Lock Tuohy with back eye and wings 18G x 90mm, Sprotte Standard with

Pajunk GmbH Medizintechnologie

Epidural/intrathecal anaesthesia set, non-medicated

• Primary Device ID: 04048223133385
• NIH Device Record Key: b0b5e2b6-4165-44b2-909c-ec8168878807
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EpiSpin Lock
• Version Model Number: 0021351-18
• Catalog Number: 0021351-18
• 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
• 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 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
• 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	04048223133125 [Primary]
GS1	04048223133385 [Package]; Contains: 04048223133125; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060563

FDA Product Code

• CAZ: Anesthesia conduction kit

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: 2025-08-07
• Device Publish Date: 2025-07-30

On-Brand Devices [EpiSpin Lock]

• 14048223009458: EpiSpin Lock Tuohy with back eye and wings 18G x 135mm, S
• 14048223009410: EpiSpin Lock Tuohy with backeye and wings 18G x 90mm, Sp
• 14048223009403: EpiSpin Lock Tuohy with back eye and wings 16G x 90mm, Sp
• 14048223009397: EpiSpin Lock Tuohy with back eye and wings 18G x 90mm, Sp
• 14048223009380: EpiSpin Lock Tuohy with back eye and wings 16G x 90mm, Sp
• 14048223009342: EpiSpin Lock Tuohy with backeye and wings 18G x 90mm, Sp
• 14048223009335: EpiSpin Lock Tuohy with backeye and wings 17G x 90mm Sprotte Standa
• 14048223009311: EpiSpin Lock Tuohy with back eye and wings 18G x 90mm, Sp
• 14048223009151: EpiSpin Lock Tuohy with backeye and wings 18G x 90mm, Sp
• 14048223009106: EpiSpin Lock Tuohy with backeye and wings 18G x 90mm Sprotte Standa
• 04048223132579: EpiSpin Lock Tuohy with backeye and wings 17G x 90mm Sprotte Standard with
• 04048223132029: EpiSpin Lock Tuohy with back eye and wings 16G x 90mm, Sprotte Standard with
• 04048223131930: EpiSpin Lock Tuohy with back eye and wings 18G x 135mm, Sprotte Standard with
• 04048223133392: EpiSpin Lock Tuohy with backeye and wings 18G x 90mm, Sprotte Standard with
• 04048223133385: EpiSpin Lock Tuohy with back eye and wings 18G x 90mm, Sprotte Standard with