RIGIDLOOP 232034

GUDID 10886705022809

RIGIDLOOP Cortical Fixation Implant Extra Large

Medos International Sàrl

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 10886705022809
• NIH Device Record Key: fe6b6702-8727-4e71-bdc1-e965972eba26
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RIGIDLOOP
• Version Model Number: 232034
• Catalog Number: 232034
• Company DUNS: 482661753
• Company Name: Medos International Sàrl
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886705022809 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130814

FDA Product Code

• MBI: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-10-04
• Device Publish Date: 2015-09-01

On-Brand Devices [RIGIDLOOP]

• 10886705022809: RIGIDLOOP Cortical Fixation Implant Extra Large
• 10886705030781: RIGIDLOOP Titanium Button
• 10886705022793: RIGIDLOOP Cortical Fixation Sterilization Mat
• 10886705022786: RIGIDLOOP Cortical System Instrument Tray
• 10886705026494: RIGIDLOOP Combo Reamer/Passing Pin - Arrow Tip (10-160mm +/- 0.1mm) 4.5mm
• 10886705024544: RIGIDLOOP Combo Reamer/Passing Pin (10-160mm Plus or Minus 0.1mm) 4.5mm
• 10886705022748: RIGIDLOOP Cortical System Passing Pin 2.4mm