TESSYS® FS6342181-15C

GUDID 04250337116028

TESSYS® FHD Foraminoscope (3.7 WCh), combo

Joimax GmbH

Spinal endoscopic-access system

• Primary Device ID: 04250337116028
• NIH Device Record Key: a382fbee-6a21-4ebb-b0c5-78a46a452c9d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TESSYS®
• Version Model Number: FS6342181-15C
• Catalog Number: FS6342181-15C
• 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: quality@joimax.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250337116028 [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

[04250337116028]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-02-19

On-Brand Devices [TESSYS®]

• 04250337117643: TESSYS® FHD Foraminoscope thoracic (3.1 WCh), Combo
• 04250337116325: TESSYS® FHD Foraminoscope (3.7 WCh), ocular
• 04250337116028: TESSYS® FHD Foraminoscope (3.7 WCh), combo
• 04250337110583: TESSYS® FHD Foraminoscope (4.7 WCh), combo
• 04250337110576: TESSYS® FHD Foraminoscope (4.7 WCh), ocular
• 04250337100492: TESSYS® HD Foraminoscope XT, (3.7 mm WCh), ocular
• 04250337100485: TESSYS® HD Foraminoscope XT, (3.7 mm WCh), combo
• 04250337100454: TESSYS® HD Foraminoscope (3.7 mm WCh), ocular
• 04250337100447: TESSYS® HD Foraminoscope (3.7 mm WCh), combo
• 04250337118411: TESSYS® FHD Foraminoscope (4.7 WCh), ocular
• 04250337118404: TESSYS® FHD Foraminoscope (4.7 WCh), combo
• 04250337117650: TESSYS® FHD Foraminoscope thoracic (3.1 WCh), ocular
• 04250337113041: TESSYS® Norm-Container H 200 mm, blue
• 04250337103448: TESSYS® Crown Reamer, yellow, fine
• 04250337103516: TESSYS® Crown Reamer, violet, coarse
• 04250337100225: TESSYS® Crown Reamer, green, coarse
• 04250337105138: TESSYS® Endoscopic Reamer
• 04250337103462: TESSYS® Crown Reamer, violet, fine
• 04250337103455: TESSYS® Crown Reamer, red, fine
• 04250337103431: TESSYS® Crown Reamer, green, fine
• 04250337103424: TESSYS® Crown Reamer, blue, fine
• 04250337103509: TESSYS® Crown Reamer, red, coarse
• 04250337103493: TESSYS® Crown Reamer, yellow, coarse