trial insert 0°

GUDID 04048844005870

implantcast GmbH

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 04048844005870
• NIH Device Record Key: f7a992cd-c1a0-436c-88d7-01bde3e1a341
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: trial insert 0°
• Version Model Number: 02253252
• 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	04048844005870 [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

[04048844005870]

Moist Heat or Steam Sterilization

[04048844005870]

Moist Heat or Steam Sterilization

[04048844005870]

Moist Heat or Steam Sterilization

[04048844005870]

Moist Heat or Steam Sterilization

[04048844005870]

Moist Heat or Steam Sterilization

[04048844005870]

Moist Heat or Steam Sterilization

[04048844005870]

Moist Heat or Steam Sterilization

[04048844005870]

Moist Heat or Steam Sterilization

[04048844005870]

Moist Heat or Steam Sterilization

[04048844005870]

Moist Heat or Steam Sterilization

[04048844005870]

Moist Heat or Steam Sterilization

[04048844005870]

Moist Heat or Steam Sterilization

[04048844005870]

Moist Heat or Steam Sterilization

[04048844005870]

Moist Heat or Steam Sterilization

[04048844005870]

Moist Heat or Steam Sterilization

[04048844005870]

Moist Heat or Steam Sterilization

[04048844005870]

Moist Heat or Steam Sterilization

[04048844005870]

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 insert 0°]

• 04048844146665: 02253239
• 04048844005900: 02253652
• 04048844005894: 02253648
• 04048844005887: 02253644
• 04048844005870: 02253252
• 04048844005863: 02253248
• 04048844005856: 02253244