trial head taper 12/14mm

GUDID 04048844293543

implantcast GmbH

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 04048844293543
• NIH Device Record Key: 3d169bd5-ab45-48d6-961b-8fc60cacacdc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: trial head taper 12/14mm
• Version Model Number: 79653605
• Company DUNS: 324369826
• Company Name: implantcast GmbH
• Device Count: 1
• DM Exempt: true
• 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: 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: false
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04048844293543 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163577

FDA Product Code

• LZO: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Sterilization

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

[04048844293543]

Moist Heat or Steam Sterilization

[04048844293543]

Moist Heat or Steam Sterilization

[04048844293543]

Moist Heat or Steam Sterilization

[04048844293543]

Moist Heat or Steam Sterilization

[04048844293543]

Moist Heat or Steam Sterilization

[04048844293543]

Moist Heat or Steam Sterilization

[04048844293543]

Moist Heat or Steam Sterilization

[04048844293543]

Moist Heat or Steam Sterilization

[04048844293543]

Moist Heat or Steam Sterilization

[04048844293543]

Moist Heat or Steam Sterilization

[04048844293543]

Moist Heat or Steam Sterilization

[04048844293543]

Moist Heat or Steam Sterilization

[04048844293543]

Moist Heat or Steam Sterilization

[04048844293543]

Moist Heat or Steam Sterilization

[04048844293543]

Moist Heat or Steam Sterilization

[04048844293543]

Moist Heat or Steam Sterilization

[04048844293543]

Moist Heat or Steam Sterilization

[04048844293543]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-04
• Device Publish Date: 2019-03-27

On-Brand Devices [trial head taper 12/14mm]

• 04048844293567: 79653615
• 04048844293550: 79653610
• 04048844293543: 79653605
• 04048844293536: 79653600
• 04048844293505: 79653215
• 04048844293499: 79653210
• 04048844293482: 79653205
• 04048844293475: 79653200
• 04048844293444: 79652815
• 04048844293437: 79652810
• 04048844293420: 79652805
• 04048844293413: 79652800