Actiflip

GUDID 00816342023962

AcTiFlip Cinch #2 w/ Needles

PARCUS MEDICAL LLC

Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 00816342023962
• NIH Device Record Key: b043f2cd-2daa-45cc-bb28-83aa3725966a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Actiflip
• Version Model Number: 11183
• 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	00816342023962 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192750

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: 2023-08-07
• Device Publish Date: 2023-07-29

On-Brand Devices [Actiflip]

• 00816342024952: Actiflip Cinch #2 w/ Needles
• M68511185SB0: Actiflip w/ #2 Infinity Loop
• 00816342024969: Actiflip w/ #2 Infinity Loop
• 00816342023979: 3.9 x 12mm AcTiFlip, w/1 infinity loop (wht/blu), w/needle, w/suture threader
• 00816342023962: AcTiFlip Cinch #2 w/ Needles