DRUJ-IS350

GUDID B013DRUJIS350

Distal Radio-Ulnar Joint Stem, 3 cm Extended, 5.0 mm Diameter

APTIS MEDICAL, LLC

Wrist ulna-head prosthesis

• Primary Device ID: B013DRUJIS350
• NIH Device Record Key: 41d13cad-bdb2-42dc-aaee-a565774c0e20
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: DRUJ-IS350
• Catalog Number: DRUJ-IS350
• Company DUNS: 780455338
• Company Name: APTIS MEDICAL, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B013DRUJIS350 [Primary]

FDA Product Code

• KXE: Prosthesis, Wrist, Hemi-, Ulnar

Sterilization

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

[B013DRUJIS350]

Ethylene Oxide

[B013DRUJIS350]

Ethylene Oxide

[B013DRUJIS350]

Ethylene Oxide

[B013DRUJIS350]

Ethylene Oxide

[B013DRUJIS350]

Ethylene Oxide

[B013DRUJIS350]

Ethylene Oxide

[B013DRUJIS350]

Ethylene Oxide

[B013DRUJIS350]

Ethylene Oxide

[B013DRUJIS350]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-06-02

Devices Manufactured by APTIS MEDICAL, LLC

• B013DRUJKW450 - Scheker DRUJ: 2023-06-16 K-Wire D. TROCAR .045"
• B013DRUJLDG250 - Scheker Prosthesis: 2023-06-09 Locking Drill Guide 2.5mm
• B013DRUJKW540 - Scheker DRUJ: 2021-12-06 K-Wire D. TROCAR 4" 1.4 MM [.054'"]
• B013DRUJKWD0 - Scheker DRUJ: 2021-12-06 K-Wire Dispenser 6 3/4"
• B013MITDRUJ1000 - Scheker DRUJ: 2021-12-06 Metal Instrument Tray, Distal Radioulnar Joint
• B013MITINT1000 - Scheker DRUJ: 2021-12-06 Metal Instrument Tray, Interchangeable
• B013DRUJB10200 - NA: 2021-09-06 Distal Radioulnar Joint Ball Size 10 or Size 20
• B013DRUJB200 - NA: 2021-09-06 UHMWP Ball, 9.5 mm, Size 20