JAWS Staple System P70-921-1518

GUDID 00889795049827

JAWS Trial Sizer 15mm and 18mm

PARAGON 28, INC.

Surgical implant template, reusable

• Primary Device ID: 00889795049827
• NIH Device Record Key: 0f94905d-7cf0-436f-baa0-e985f53c22d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JAWS Staple System
• Version Model Number: P70-921-1518
• Catalog Number: P70-921-1518
• Company DUNS: 042961576
• Company Name: PARAGON 28, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	00889795049827 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170923

FDA Product Code

• JDR: Staple, fixation, bone

Sterilization

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

[00889795049827]

Moist Heat or Steam Sterilization

[00889795049827]

Moist Heat or Steam Sterilization

[00889795049827]

Moist Heat or Steam Sterilization

[00889795049827]

Moist Heat or Steam Sterilization

[00889795049827]

Moist Heat or Steam Sterilization

[00889795049827]

Moist Heat or Steam Sterilization

[00889795049827]

Moist Heat or Steam Sterilization

[00889795049827]

Moist Heat or Steam Sterilization

[00889795049827]

Moist Heat or Steam Sterilization

[00889795049827]

Moist Heat or Steam Sterilization

[00889795049827]

Moist Heat or Steam Sterilization

[00889795049827]

Moist Heat or Steam Sterilization

[00889795049827]

Moist Heat or Steam Sterilization

[00889795049827]

Moist Heat or Steam Sterilization

[00889795049827]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-23
• Device Publish Date: 2020-12-15

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