MUTARS® screw

GUDID 04048844115982

implantcast GmbH

Implantable orthopaedic fixation device connection screw

• Primary Device ID: 04048844115982
• NIH Device Record Key: 3fe21679-3b72-4654-9c09-156c56310b17
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MUTARS® screw
• Version Model Number: 57921005
• Company DUNS: 324369826
• Company Name: implantcast GmbH
• 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: true
• 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 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	04048844115982 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181778

FDA Product Code

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

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-15
• Device Publish Date: 2019-04-05

On-Brand Devices [MUTARS® screw]

• 04048844116026: 57921013
• 04048844116019: 57921011
• 04048844116002: 57921009
• 04048844115999: 57921007
• 04048844115982: 57921005
• 04048844050870: 57921024
• 04048844050863: 57921022
• 04048844050856: 57921020
• 04048844050849: 57921018
• 04048844050832: 57921016
• 04048844050825: 57921014
• 04048844050818: 57921012
• 04048844050801: 57921010
• 04048844050795: 57921008
• 04048844050788: 57921006
• 04048844050771: 57921004
• 04048844050764: 57921002