JAWS Nitinol Staple System P71-015-1515-S

GUDID 00889795040305

Straight Staple Assembly, 15 x 15mm

PARAGON 28, INC.

Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable

• Primary Device ID: 00889795040305
• NIH Device Record Key: 74073b80-7072-4adc-ad32-28d5d7d35669
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JAWS Nitinol Staple System
• Version Model Number: P71-015-1515-S
• Catalog Number: P71-015-1515-S
• Company DUNS: 042961576
• Company Name: PARAGON 28, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: true
• 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	00889795040305 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170923

FDA Product Code

• JDR: Staple, fixation, bone

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: 2020-01-24
• Device Publish Date: 2020-01-16

On-Brand Devices [JAWS Nitinol Staple System]

• 00889795056696: Compressor
• 00889795049926: Straight Staple Assembly, 25 x 20mm
• 00889795040336: Straight Staple Assembly, 20 x 20mm
• 00889795040312: Straight Staple Assembly, 18 x 18mm
• 00889795040305: Straight Staple Assembly, 15 x 15mm
• 00889795023681: Angled Staple Assembly, 10 x 10mm
• 00889795023674: Angled Staple Assembly, 8 x 8mm
• 00889795023667: Straight Staple Assembly, 10 x 10mm
• 00889795023650: Straight Staple Assembly, 8 x 8mm