ic-head CoCrMo taper 12/14

GUDID 04048844017132

implantcast GmbH

Metallic femoral head prosthesis

• Primary Device ID: 04048844017132
• NIH Device Record Key: 291c7c80-1aba-461a-985a-2bd5652445fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ic-head CoCrMo taper 12/14
• Version Model Number: 23873215
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	04048844017132 [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: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-04-06
• Device Publish Date: 2017-10-31

On-Brand Devices [ic-head CoCrMo taper 12/14]

• 04048844255596: 23873610
• 04048844255589: 23873600
• 04048844245290: 23873615
• 04048844245276: 23873605
• 04048844017132: 23873215
• 04048844017125: 23873210
• 04048844017118: 23873205
• 04048844017101: 23873200
• 04048844017071: 23872815
• 04048844017064: 23872810
• 04048844017057: 23872805
• 04048844017040: 23872800