GFS

GUDID 00816342021746

GFS II Large 35mm Loop

PARCUS MEDICAL LLC

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 00816342021746
• NIH Device Record Key: fb6a11e7-5287-4846-8170-51f367eb3482
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GFS
• Version Model Number: 10707
• Company DUNS: 859961950
• Company Name: PARCUS MEDICAL LLC
• Device Count: 1
• DM Exempt: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816342021746 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133757

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-03
• Device Publish Date: 2023-07-26

On-Brand Devices [GFS]

• 00816342021968: GFS II XLG Naked
• 00816342021951: GFS II LG Naked
• 00816342021944: GFS II Std Naked
• 00816342021937: GFS Mini Naked
• 00816342021920: GFS Micro Naked
• 00816342021913: GFS Nano Naked
• 00816342021906: GFS Mini 60mm Loop
• 00816342021890: GFS Mini 55mm Loop
• 00816342021883: GFS Mini 50mm Loop
• 00816342021876: GFS Mini 45mm Loop
• 00816342021869: GFS Mini 40mm Loop
• 00816342021852: GFS Mini 35mm Loop
• 00816342021845: GFS Mini 30mm Loop
• 00816342021838: GFS Mini 25mm Loop
• 00816342021821: GFS Mini 20mm Loop
• 00816342021814: GFS Mini 15mm Loop
• 00816342021807: GFS Mini 12mm Loop
• 00816342021791: GFS II Large 60mm Loop
• 00816342021784: GFS II Large 55mm Loop
• 00816342021777: GFS II Large 50mm Loop
• 00816342021760: GFS II Large 45mm Loop
• 00816342021753: GFS II Large 40mm Loop
• 00816342021746: GFS II Large 35mm Loop
• 00816342021739: GFS II Large 30mm Loop
• 00816342021722: GFS II Large 25mm Loop
• 00816342021715: GFS II Large 20mm Loop
• 00816342021708: GFS II Large 15mm Loop
• 00816342025164: GFS Ultimate Micro
• 00816342024976: GFS BTB Link
• 00816342024518: GFS Ultimate Hip
• 00816342022514: GFS Ultimate Large
• 00816342022507: GFS Ultimate Mini