HammerTube System P40-XRY-TPLT

GUDID 00889795057686

HammerToe Implant X-ray Overlay (HammerGraft & Hammertube)

PARAGON 28, INC.

Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable

• Primary Device ID: 00889795057686
• NIH Device Record Key: 6e62fbf9-2a1a-40c5-adb6-803e466f7394
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HammerTube System
• Version Model Number: P40-XRY-TPLT
• Catalog Number: P40-XRY-TPLT
• Company DUNS: 042961576
• Company Name: PARAGON 28, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 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	00889795057686 [Primary]

FDA Product Code

• HWT: TEMPLATE

Sterilization

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

[00889795057686]

Moist Heat or Steam Sterilization

[00889795057686]

Moist Heat or Steam Sterilization

[00889795057686]

Moist Heat or Steam Sterilization

[00889795057686]

Moist Heat or Steam Sterilization

[00889795057686]

Moist Heat or Steam Sterilization

[00889795057686]

Moist Heat or Steam Sterilization

[00889795057686]

Moist Heat or Steam Sterilization

[00889795057686]

Moist Heat or Steam Sterilization

[00889795057686]

Moist Heat or Steam Sterilization

[00889795057686]

Moist Heat or Steam Sterilization

[00889795057686]

Moist Heat or Steam Sterilization

[00889795057686]

Moist Heat or Steam Sterilization

[00889795057686]

Moist Heat or Steam Sterilization

[00889795057686]

Moist Heat or Steam Sterilization

[00889795057686]

Moist Heat or Steam Sterilization

[00889795057686]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-22
• Device Publish Date: 2022-09-14

On-Brand Devices [HammerTube System]

• 00889795057679: HammerTube Implant, 3.50mm, 10° Cannulated
• 00889795057662: HammerTube Implant, 2.75mm, 10° Cannulated
• 00889795057655: HammerTube Implant, 3.50mm, 0° Cannulated
• 00889795057648: HammerTube Implant, 2.75mm, 0° Cannulated
• 00889795041616: K-Wire, Double Ended Trocar Tip, 1.6mm x 150mm
• 00889795041609: K-Wire, Double Ended Trocar Tip, 1.4mm x 150mm
• 00889795041517: Drill Insert Trocar Tip, 1.6mm x 70mm (Patent Pending)
• 00889795041500: Drill Insert Trocar Tip, 1.4mm x 70mm (Patent Pending)
• 00889795041494: Drill Insert Trocar Tip, 1.1mm x 70mm (Patent Pending)
• 00889795039392: Hammertoe, Implant Puller
• 00889795039385: HammerTube Extractor Tool
• 00889795039378: Implant Inserter, 3.5mm
• 00889795039361: Implant Inserter, 2.8mm
• 00889795039354: Implant Inserter, 2.75mm
• 00889795039347: Implant Inserter, 2.3mm
• 00889795039323: K-Wire, Double Ended Trocar Tip, 1.6mm x 30mm, Blunt
• 00889795039316: K-Wire, Double Ended Trocar Tip, 1.4mm x 30mm, Blunt
• 00889795039309: K-Wire, Double Ended Trocar Tip, 1.1mm x 30mm, Blunt
• 00889795039446: Drill, 2.75mm, Cannulated (Patent Pending)
• 00889795039439: Drill, 2.65mm, Cannulated (Patent Pending)
• 00889795039422: Drill, 2.15mm, Cannulated (Patent Pending)
• 00889795097415: HammerToe, Caddy, Lid
• 00889795097408: HammerToe, Caddy, Insert
• 00889795097392: HammerToe, Caddy, Base
• 00889795039453: Drill, 3.5mm, Cannulated (Patent Pending)
• 00889795039330: Bone Planer, 8mm (Patent Pending)
• 00889795057686: HammerToe Implant X-ray Overlay (HammerGraft & Hammertube)
• 00889795039415: Trephine Ø3.50mm
• 00889795039408: Trephine Ø2.75mm