n.a. 031131-10

GUDID 04048438001042

Tubing Set, UNIDRIVE/UNIDRIVE SIII

Karl Storz GmbH & Co. KG

Surgical irrigation tubing set, single-use

• Primary Device ID: 04048438001042
• NIH Device Record Key: 9470567a-4069-4ffd-89f8-349d87d240ed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: n.a.
• Version Model Number: 031131-10
• Catalog Number: 031131-10
• Company DUNS: 315731430
• Company Name: Karl Storz GmbH & Co. KG
• Device Count: 10
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +14242188201
• Email: regulatory@karlstorz.com
• Phone: +14242188201
• Email: regulatory@karlstorz.com
• Phone: +14242188201
• Email: regulatory@karlstorz.com
• Phone: +14242188201
• Email: regulatory@karlstorz.com
• Phone: +14242188201
• Email: regulatory@karlstorz.com
• Phone: +14242188201
• Email: regulatory@karlstorz.com
• Phone: +14242188201
• Email: regulatory@karlstorz.com
• Phone: +14242188201
• Email: regulatory@karlstorz.com
• Phone: +14242188201
• Email: regulatory@karlstorz.com
• Phone: +14242188201
• Email: regulatory@karlstorz.com
• Phone: +14242188201
• Email: regulatory@karlstorz.com
• Phone: +14242188201
• Email: regulatory@karlstorz.com
• Phone: +14242188201
• Email: regulatory@karlstorz.com
• Phone: +14242188201
• Email: regulatory@karlstorz.com
• Phone: +14242188201
• Email: regulatory@karlstorz.com
• Phone: +14242188201
• Email: regulatory@karlstorz.com
• Phone: +14242188201
• Email: regulatory@karlstorz.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04048438001035 [Unit of Use]
GS1	04048438001042 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021811

FDA Product Code

• ERL: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-03-19
• Device Publish Date: 2016-09-23

On-Brand Devices [n.a.]

• 04048551075623: Working Element, bipolar
• 04048551405116: Articulated Arm, only
• 04048551366967: Mobile Stand for 28272 HS
• 04048551322482: Clamping Jaw, with ball joint, small
• 04048551322475: Clamping Jaw, with ball joint, large
• 04048551313114: Extension Rod, 50cm
• 04048551175811: BÜCHS Cheek Retractor, 20.5 cm
• 04048551175637: Elevator, width 8 mm, length 20 cm
• 04048551175569: Elevator, width 5 mm, length 20 cm
• 04048551078150: Pick 90°,bay., downwards, 1 mm, 18 cm
• 04048551078143: Pick 90°, bay., upwards, 1 mm, 18 cm
• 04048551078105: Pick 90°, bay., upwards, 0.5 mm, 18.5 cm
• 04048551100080: Elevator, 4mm, 19cm
• 04048551365328: Suction and Irrigation Tube
• 04048551365304: Suction and Irrigation Tube
• 04048551337691: Irrigation-Suction Sheath for 7230 AE
• 04048551313848: Irrigation Tube, 100K
• 04048551313824: Irrigation Tube for Handpiece
• 04048551313695: Irrigation Tube, 100K
• 04048551313640: Irrigation Tube, 60K
• 04048551310793: Suction and Irrigation Tube, 3 mm
• 04048551310786: Suction and Irrigation Tube, 3 mm
• 04048551310779: Suction and Irrigation Tube, 3 mm
• 04048551288825: TWINFlow Suction/Irrig. Tube, 4mm x 13cm
• 04048551288801: TWINFlow Suction/Irrig. Tube, 4mm x 9cm
• 04048551288795: TWINFlow Suction/Irrig. Tube, 2mm x 13cm
• 04048551288788: TWINFlow Suction/Irrig. Tube, 2mm x 9cm
• 04048551279526: Suction and Irrigation Tube, 13cm
• 04048551279434: WULLSTEIN Suction/Irrigation Tube, 13cm
• 04048551279427: Suction and Irrigation Tube, 15cm
• 04048551267608: Tappet, Ø 12 mm
• 04048551267462: Sleeve, Ø 12 mm
• 04048551267455: Sleeve, Ø 11 mm
• 04048551267448: Sleeve, Ø 9 mm
• 04048551267431: Sleeve, Ø 10 mm
• 04048551267424: Sleeve, Ø 8 mm
• 04048551267417: Sleeve, Ø 7 mm
• 04048551267394: Sleeve, Ø 6 mm
• 04048551267387: Tap
• 04048551267363: Sleeve, Ø 5 mm
• 04048551267332: Tappet, Ø 11 mm
• 04048551267325: Tappet, Ø 10 mm
• 04048551267318: Tappet, Ø 9 mm
• 04048551267301: Tappet, Ø 7 mm
• 04048551267295: Tappet, Ø 8 mm
• 04048551267288: Tappet, Ø 6 mm
• 04048551267271: Tappet, Ø 5 mm
• 04048551258651: Suction and Irrigation Tube
• 04048551258125: Irrigation and Suction tube, size 3 mm
• 04048551194621: Knurled ring, diameter 16 mm