IJS-E IJS-PUP-BPA

GUDID 00841506109107

IJS-E Base Plate Assembly, Proximal Ulna Plate

SKELETAL DYNAMICS L.L.C.

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00841506109107
• NIH Device Record Key: d1ac257b-87d0-4392-9976-00a5bb76e80e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IJS-E
• Version Model Number: IJS
• Catalog Number: IJS-PUP-BPA
• Company DUNS: 869056148
• Company Name: SKELETAL DYNAMICS L.L.C.
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(305)596-7585
• Email: feedback@skeletaldynamics.com
• Phone: +1(305)596-7585
• Email: feedback@skeletaldynamics.com
• Phone: +1(305)596-7585
• Email: feedback@skeletaldynamics.com
• Phone: +1(305)596-7585
• Email: feedback@skeletaldynamics.com
• Phone: +1(305)596-7585
• Email: feedback@skeletaldynamics.com
• Phone: +1(305)596-7585
• Email: feedback@skeletaldynamics.com
• Phone: +1(305)596-7585
• Email: feedback@skeletaldynamics.com
• Phone: +1(305)596-7585
• Email: feedback@skeletaldynamics.com
• Phone: +1(305)596-7585
• Email: feedback@skeletaldynamics.com
• Phone: +1(305)596-7585
• Email: feedback@skeletaldynamics.com
• Phone: +1(305)596-7585
• Email: feedback@skeletaldynamics.com
• Phone: +1(305)596-7585
• Email: feedback@skeletaldynamics.com
• Phone: +1(305)596-7585
• Email: feedback@skeletaldynamics.com
• Phone: +1(305)596-7585
• Email: feedback@skeletaldynamics.com
• Phone: +1(305)596-7585
• Email: feedback@skeletaldynamics.com
• Phone: +1(305)596-7585
• Email: feedback@skeletaldynamics.com
• Phone: +1(305)596-7585
• Email: feedback@skeletaldynamics.com
• Phone: +1(305)596-7585
• Email: feedback@skeletaldynamics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841506109107 [Primary]

FDA Product Code

• OZI: Internal hinged elbow fixator

Sterilization

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

[00841506109107]

Moist Heat or Steam Sterilization

[00841506109107]

Moist Heat or Steam Sterilization

[00841506109107]

Moist Heat or Steam Sterilization

[00841506109107]

Moist Heat or Steam Sterilization

[00841506109107]

Moist Heat or Steam Sterilization

[00841506109107]

Moist Heat or Steam Sterilization

[00841506109107]

Moist Heat or Steam Sterilization

[00841506109107]

Moist Heat or Steam Sterilization

[00841506109107]

Moist Heat or Steam Sterilization

[00841506109107]

Moist Heat or Steam Sterilization

[00841506109107]

Moist Heat or Steam Sterilization

[00841506109107]

Moist Heat or Steam Sterilization

[00841506109107]

Moist Heat or Steam Sterilization

[00841506109107]

Moist Heat or Steam Sterilization

[00841506109107]

Moist Heat or Steam Sterilization

[00841506109107]

Moist Heat or Steam Sterilization

[00841506109107]

Moist Heat or Steam Sterilization

[00841506109107]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-28
• Device Publish Date: 2023-06-20

On-Brand Devices [IJS-E]

• 00841506109374: IJS Sterilization Tray Implant & Screw Caddy
• 00841506109305: IJS Sterilization Tray
• 00841506109138: Twin IJS-E, Assembly
• 00841506109107: IJS-E Base Plate Assembly, Proximal Ulna Plate
• 00841506107271: Cutting Pliers
• 00841506107226: #4-40 Screws
• 00841506105734: Torque Limiting Handle, 20 in-lb