Spinal Manometer 001151-38G

GUDID 04048223048986

Spinal Manometer with three-way cock

Pajunk GmbH Medizintechnologie

Cerebrospinal fluid manometer, mechanical

• Primary Device ID: 04048223048986
• NIH Device Record Key: 5fb660cd-7bbd-44d7-9677-93eebeb8ffab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spinal Manometer
• Version Model Number: 001151-38G
• Catalog Number: 001151-38G
• 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

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	04048223048986 [Package]; Contains: 04048223069578; Package: [10 Units]; In Commercial Distribution
GS1	04048223069578 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170305

FDA Product Code

• FMJ: MANOMETER, SPINAL-FLUID

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

Devices Manufactured by Pajunk GmbH Medizintechnologie

• 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
• 04048223129999 - Standard Sprotte Needle: 2025-09-25 Standard Sprotte Needle 25G x 3 1/2" (90mm), sterile with Introducer and wings