| Primary Device ID | 10886705024544 | 
| NIH Device Record Key | 90ff202e-1661-4069-b107-d7b768711368 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | RIGIDLOOP | 
| Version Model Number | 232453 | 
| Catalog Number | 232453 | 
| Company DUNS | 482661753 | 
| Company Name | Medos International Sàrl | 
| Device Count | 1 | 
| DM Exempt | false | 
| Pre-market Exempt | true | 
| 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 | 
| Phone | +1(800)255-2500 | 
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| Phone | +1(800)255-2500 | 
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| Phone | +1(800)255-2500 | 
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| Phone | +1(800)255-2500 | 
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| Phone | +1(800)255-2500 | 
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| Phone | +1(800)255-2500 | 
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| Phone | +1(800)255-2500 | 
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| Phone | +1(800)255-2500 | 
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| Phone | +1(800)255-2500 | 
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| Phone | +1(800)255-2500 | 
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| Phone | +1(800)255-2500 | 
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| Phone | +1(800)255-2500 | 
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| Phone | +1(800)255-2500 | 
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| Phone | +1(800)255-2500 | 
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| Phone | +1(800)255-2500 | 
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| Phone | +1(800)255-2500 | 
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| Phone | +1(800)255-2500 | 
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| Phone | +1(800)255-2500 | 
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| Phone | +1(800)255-2500 | 
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| Phone | +1(800)255-2500 | 
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| Phone | +1(800)255-2500 | 
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| Phone | +1(800)255-2500 | 
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| Phone | +1(800)255-2500 | 
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| Phone | +1(800)255-2500 | 
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| Phone | +1(800)255-2500 | 
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| Phone | +1(800)255-2500 | 
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| Phone | +1(800)255-2500 | 
| xx@xx.xx | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 10886705024544 [Primary] | 
| HWE | INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT | 
| Steralize Prior To Use | false | 
| Device Is Sterile | true | 
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 4 | 
| Public Version Date | 2021-12-10 | 
| Device Publish Date | 2015-09-01 | 
| 10886705022809 | RIGIDLOOP Cortical Fixation Implant Extra Large | 
| 10886705030781 | RIGIDLOOP Titanium Button | 
| 10886705022793 | RIGIDLOOP Cortical Fixation Sterilization Mat | 
| 10886705022786 | RIGIDLOOP Cortical System Instrument Tray | 
| 10886705026494 | RIGIDLOOP Combo Reamer/Passing Pin - Arrow Tip (10-160mm +/- 0.1mm) 4.5mm | 
| 10886705024544 | RIGIDLOOP Combo Reamer/Passing Pin (10-160mm Plus or Minus 0.1mm) 4.5mm | 
| 10886705022748 | RIGIDLOOP Cortical System Passing Pin 2.4mm | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  RIGIDLOOP  98775049  not registered Live/Pending | Johnson & Johnson 2024-09-27 | 
|  RIGIDLOOP  85803563  4656789 Live/Registered | Johnson & Johnson 2012-12-14 |