joimax® FS6342181C-4K

GUDID 04250337118473

4K UHD Foraminoscope

Joimax GmbH

Spinal endoscopic-access system

• Primary Device ID: 04250337118473
• NIH Device Record Key: 6fedb224-7877-4099-ab67-b09e9abd9069
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: joimax®
• Version Model Number: FS6342181C-4K
• Catalog Number: FS6342181C-4K
• Company DUNS: 344267187
• Company Name: Joimax GmbH
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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: +49721255140
• Email: customercare@joimax.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250337118473 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051827

FDA Product Code

• HRX: Arthroscope

Sterilization

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

[04250337118473]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-21
• Device Publish Date: 2019-10-11

On-Brand Devices [joimax®]

• 04250337114321: FHD Hybrid Scope, combo
• 04250337111252: HD Laminoscope [3.7 mm WCh] with ocular
• 04250337111245: HD Laminoscope [3.7 mm WCh]
• 04250337111238: Full HD Foramino- / Laminoscope with ocular
• 04250337111221: Full HD Foramino- / Laminoscope
• 04250337109679: HD Nucleoscope [1.9 mm OD] Ocular
• 04250337109662: HD Nucleoscope [1.9 mm OD], Combo
• 04250337107606: Working Tube Adapter L 40 mm / OD 19 mm / ID 6.5 mm
• 04250337107590: Working Tube Adapter L 40 mm / OD 16 mm / ID 6.5 mm
• 04250337107583: joimax® Guide Wire, super elastic, unsterile
• 04250337107576: joimax® Cage Pusher
• 04250337107569: Cage Inserter
• 04250337105923: joimax® Guide Wire, super elastic, unsterile
• 04250337105800: HD Nucleoscope [2.7 mm OD] Ocular
• 04250337105794: HD Nucleoscope [2.7 mm OD] Combo
• 04250337105787: HD Multiscope [3.1 mm WCh] with Ocular
• 04250337105770: HD Multiscope [3.1 mm WCh], combo
• 04250337102052: joimax® Irrigation Spine Pump
• 04250337100751: joimax® Multi-Range Irrigation Pump
• 04250337100430: HD Foramino-/ Laminoscope (2.7 mm WCh) with ocular
• 04250337100423: HD Foramino-/ Laminoscope (2.7 mm WCh), combo
• 04250337100041: joimax® Arthroscope Combo WL 175 mm / OD 4.0 mm / 70°
• 04250337100034: joimax® Arthroscope Combo WL 175 mm / OD 4.0 mm / 45°
• 04250337100027: joimax® Arthroscope Combo WL 175 mm / OD 4.0 mm / 30°
• 04250337100010: joimax® Arthroscope Combo
• 04250337100003: joimax® Arthroscope Combo
• 04250337118480: 4K UHD Foraminoscope
• 04250337118473: 4K UHD Foraminoscope