ESOP®

GUDID 03661489452703

FOURNITURES HOSPITALIERES INDUSTRIE

Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell

• Primary Device ID: 03661489452703
• NIH Device Record Key: e6384bfa-025c-43d9-8825-e5bdede440c9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ESOP®
• Version Model Number: 245270 - PE/LINER ANTI-DISLOCATION, Ø28/Ø68
• 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	03661489452703 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K961388

FDA Product Code

• MEH: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate

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 [ESOP®]

• 03661489452710: 245271 - PE/LINER ANTI-DISLOCATION, Ø32/Ø68
• 03661489452703: 245270 - PE/LINER ANTI-DISLOCATION, Ø28/Ø68
• 03661489452697: 245269 - PE/LINER ANTI-DISLOCATION, Ø22,22/Ø68
• 03661489452680: 245268 - PE/LINER ANTI-DISLOCATION, Ø28/Ø66
• 03661489452673: 245267 - PE/LINER ANTI-DISLOCATION, Ø32/Ø66
• 03661489452666: 245266 - PE/LINER ANTI-DISLOCATION, Ø22,22/Ø66
• 03661489452659: 245265 - PE/LINER ANTI-DISLOCATION Ø28/Ø64
• 03661489452642: 245264 - PE/LINER ANTI-DISLOCATION, Ø32/Ø64
• 03661489452635: 245263 - PE/LINER ANTI-DISLOCATION, Ø22,22/Ø64
• 03661489452628: 245262 - PE/LINER ANTI-DISLOCATION, Ø28/Ø62
• 03661489452611: 245261 - PE/LINER ANTI-DISLOCATION, Ø32/Ø62
• 03661489452604: 245260 - PE/LINER ANTI-DISLOCATION, Ø22,22/Ø62
• 03661489452598: 245259 - PE/LINER ANTI-DISLOCATION Ø28/Ø60
• 03661489452581: 245258 - PE/LINER ANTI-DISLOCATION Ø32/Ø60
• 03661489452574: 245257 - PE/LINER ANTI-DISLOCATION Ø22,22/Ø60
• 03661489452567: 245256 - PE/LINER ANTI-DISLOCATION Ø28/Ø58
• 03661489452550: 245255 - PE/LINER ANTI-DISLOCATION Ø32/Ø58
• 03661489452543: 245254 - PE/LINER ANTI-DISLOCATION Ø22,22/Ø58
• 03661489452536: 245253 - PE/LINER ANTI-DISLOCATION, Ø28/Ø56
• 03661489452529: 245252 - PE/LINER ANTI-DISLOCATION Ø32/Ø56
• 03661489452512: 245251 - PE/LINER ANTI-DISLOCATION Ø22,22/Ø56
• 03661489452505: 245250 -PE/LINER ANTI-DISLOCATION Ø28/Ø54
• 03661489452499: 245249 - PE/LINER ANTI-DISLOCATION Ø32/Ø54
• 03661489452482: 245248 - PE/LINER ANTI-DISLOCATION Ø22,22/Ø54
• 03661489452475: 245247 - PE/LINER ANTI-DISLOCATION Ø28/Ø52
• 03661489452468: 245246 - PE/LINER ANTI-DISLOCATION Ø32/Ø52
• 03661489452451: 245245 - PE/LINER ANTI-DISLOCATION Ø22,22/Ø52
• 03661489452444: 245244 - PE/LINER ANTI-DISLOCATION , Ø28/Ø50
• 03661489452437: 245243 - PE/LINER ANTI-DISLOCATION Ø32/Ø50
• 03661489452420: 245242 - PE/LINER ANTI-DISLOCATION Ø22,22/Ø50
• 03661489452413: 245241 - PE/LINER ANTI-DISLOCATION Ø28/Ø48
• 03661489452406: 245240 -PE/LINER ANTI-DISLOCATION Ø22,22/Ø48
• 03661489452390: 245239 - PE/LINER ANTI-DISLOCATION Ø28/Ø46
• 03661489452383: 245238 - PE/LINER ANTI-DISLOCATION Ø22,22/Ø46
• 03661489452246: 245224 - SCREW FOR IMPACTED SHELL, Ø6,5 / L70
• 03661489452239: 245223 - SCREW FOR IMPACTED SHELL, Ø6,5 / L60
• 03661489452222: 245222 - SCREW FOR IMPACTED SHELL, Ø6,5 / L50
• 03661489452215: 245221 - SCREW FOR IMPACTED SHELL, Ø6,5 / L45
• 03661489452208: 245220 - SCREW FOR IMPACTED SHELL, Ø6,5 / L40
• 03661489452192: 245219 - SCREW FOR IMPACTED SHELL, Ø6,5 / L35
• 03661489452185: 245218 - SCREW FOR IMPACTED SHELL, Ø6,5 / L30
• 03661489452178: 245217 - SCREW FOR IMPACTED SHELL, Ø6,5 / L25
• 03661489452161: 245216 - SCREW FOR IMPACTED SHELL, Ø6,5 / L20
• 03661489452154: 245215 - SCREW FOR IMPACTED SHELL, Ø6,5 / L15
• 03661489450945: 245094 - ACETABULAR LINER/PE, Ø32 / Ø68
• 03661489450938: 245093 - ACETABULAR LINER/PE, Ø28 / Ø68
• 03661489450914: 245091 - ACETABULAR LINER/PE, Ø32 / Ø66
• 03661489450907: 245090 - ACETABULAR LINER/PE, Ø28 / Ø66
• 03661489450884: 245088 - ACETABULAR LINER/PE, Ø32 / Ø64
• 03661489450877: 245087 - ACETABULAR LINER/PE, Ø28 / Ø64