Femoral Head

GUDID 03661489538308

FOURNITURES HOSPITALIERES INDUSTRIE

Ceramic femoral head prosthesis

• Primary Device ID: 03661489538308
• NIH Device Record Key: 4346577b-fd30-40ca-abff-944c89e4411f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Femoral Head
• Version Model Number: 253830 - 12/14 TAPER ALUMINA HEAD, Ø28/L(+3,5)
• Company DUNS: 261839898
• Company Name: FOURNITURES HOSPITALIERES INDUSTRIE
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03661489538308 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042035

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: 2020-09-09
• Device Publish Date: 2015-10-24

On-Brand Devices [Femoral Head]

• 03661489408748: 240874 - TAPER CoCr HEAD, Ø32 / L(+10)
• 03661489408731: 240873 - 12/14 TAPER CoCr HEAD, Ø32 / L(+7)
• 03661489408724: 240872 - 12/14 TAPER CoCr HEAD, Ø32 / L(+3,5)
• 03661489408717: 240871 - 12/14 TAPER CoCr HEAD, Ø32 / M(0)
• 03661489408700: 240870 - 12/14 TAPER CoCr HEAD, Ø32 / C(-3,5)
• 03661489408663: 240866 - 12/14 TAPER CoCr HEAD, Ø28 / L(+10)
• 03661489408656: 240865 - 12/14 TAPER CoCr HEAD, Ø28 / L(+7)
• 03661489408649: 240864 - 12/14 TAPER CoCr HEAD, Ø28 / L(+3,5)
• 03661489408632: 240863 - 12/14 TAPER CoCr HEAD, Ø28 / M(0)
• 03661489408625: 240862 - 12/14 TAPER CoCr HEAD, Ø28 / C(-3,5)
• 03661489408595: 240859 - 12/14 TAPER CoCr HEAD, Ø22 / L(+2)
• 03661489408588: 240858 - 12/14 TAPER CoCr HEAD, Ø22 / M(0)
• 03661489538339: 253833 - 12/14 TAPER ALUMINA HEAD, Ø32/L(+3,5)
• 03661489538322: 253832 - 12/14 TAPER ALUMINA HEAD, Ø32/M(0)
• 03661489538315: 253831 - 12/14 TAPER ALUMINA HEAD, Ø32/S(-3,5)
• 03661489538308: 253830 - 12/14 TAPER ALUMINA HEAD, Ø28/L(+3,5)
• 03661489538292: 253829 - 12/14 TAPER ALUMINA HEAD, Ø28/M(0)
• 03661489538285: 253828 - 12/14 TAPER ALUMINA HEAD, Ø28/S(-3,5), Ø4