Wings 0001151-19

GUDID 14048223002831

Wings single packed, sterile

Pajunk GmbH Medizintechnologie

Epidural needle, non-threaded

• Primary Device ID: 14048223002831
• NIH Device Record Key: 3fd43e2b-5cd3-438e-982e-7e0ea0e739ad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Wings
• Version Model Number: 0001151-19
• Catalog Number: 0001151-19
• Company DUNS: 317654283
• Company Name: Pajunk GmbH Medizintechnologie
• Device Count: 25
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(888)972-5865
• Email: info@pajunk-usa.com
• Phone: +1(888)972-5865
• Email: info@pajunk-usa.com
• Phone: +1(888)972-5865
• Email: info@pajunk-usa.com
• Phone: +1(888)972-5865
• Email: info@pajunk-usa.com
• Phone: +1(888)972-5865
• Email: info@pajunk-usa.com
• Phone: +1(888)972-5865
• Email: info@pajunk-usa.com
• Phone: +1(888)972-5865
• Email: info@pajunk-usa.com
• Phone: +1(888)972-5865
• Email: info@pajunk-usa.com
• Phone: +1(888)972-5865
• Email: info@pajunk-usa.com
• Phone: +1(888)972-5865
• Email: info@pajunk-usa.com
• Phone: +1(888)972-5865
• Email: info@pajunk-usa.com
• Phone: +1(888)972-5865
• Email: info@pajunk-usa.com
• Phone: +1(888)972-5865
• Email: info@pajunk-usa.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04048223002834 [Unit of Use]
GS1	14048223002831 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160297

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: 2019-04-16
• Device Publish Date: 2019-04-08

Devices Manufactured by Pajunk GmbH Medizintechnologie

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• 04048223075524 - TUOHY: 2025-02-10 TUOHY NANOLINE 22GX100
• 04048223043486 - UniPlex® NanoLine®: 2025-02-07 UniPlex® NanoLine® UP 3/50, 22G (0,70) x 50mm, with injection tube and connecting cable
• 04048223045930 - Tuohy: 2025-02-07 Tuohy with spec. Point 18G x 3 1/2", metal stylet
• 04048223048870 - Flat filter 0,2µm round: 2025-02-07 Flat filter 0,2µm round sterile
• 04048223048887 - Injection Tube, LL male/LL female: 2025-02-07 Injection Tube, LL male/LL female plastic, total length 600mm, sterile
• 04048223048955 - ClampingAdapter - white -: 2025-02-07 ClampingAdapter - white - steril
• 04048223048986 - Spinal Manometer: 2025-02-07 Spinal Manometer with three-way cock