Femoral Head

GUDID 03661489538315

FOURNITURES HOSPITALIERES INDUSTRIE

Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis

• Primary Device ID: 03661489538315
• NIH Device Record Key: e9029908-8391-433b-8422-c5c2a87fea63
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Femoral Head
• Version Model Number: 253831 - 12/14 TAPER ALUMINA HEAD, Ø32/S(-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	03661489538315 [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