JAWS Staple System P71-012-1212-S

GUDID 00889795114082

JAWS Staple, 12mm, 12 x 12 Straight

PARAGON 28, INC.

Orthopaedic bone staple, non-adjustable

• Primary Device ID: 00889795114082
• NIH Device Record Key: 62c13f8a-1f85-44dd-9c4c-5b934282e192
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JAWS Staple System
• Version Model Number: P71-012-1212-S
• Catalog Number: P71-012-1212-S
• Company DUNS: 042961576
• Company Name: PARAGON 28, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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	00889795114082 [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: 2022-10-24
• Device Publish Date: 2022-10-14

On-Brand Devices [JAWS Staple System]

• 00889795049834: JAWS Trial Sizer 20mm and 25mm
• 00889795049827: JAWS Trial Sizer 15mm and 18mm
• 00889795049810: JAWS Trial Sizer 8mm and 10mm
• 00889795049803: JAWS Staple Instrument Caddy, Lid
• 00889795049797: JAWS Staple Intrument Caddy, Base
• 00889795114143: JAW STAPLE SYS, SMOOTH LOC PIN
• 00889795114082: JAWS Staple, 12mm, 12 x 12 Straight