ESOP®

GUDID 03661489450785

FOURNITURES HOSPITALIERES INDUSTRIE

Acetabular shell

• Primary Device ID: 03661489450785
• NIH Device Record Key: 67b8bbaa-60f7-46ed-b93b-126187cc9702
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ESOP®
• Version Model Number: 245078 - ACETABULAR LINER/PE, Ø28 / Ø58
• 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	03661489450785 [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