| Primary Device ID | 00887868269943 | 
| NIH Device Record Key | 9f7995d4-b201-479f-a151-b1ac6027e8d6 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | AperFix® | 
| Version Model Number | CM-7300 | 
| Catalog Number | CM-7300 | 
| Company DUNS | 606719685 | 
| Company Name | CAYENNE MEDICAL, INC. | 
| 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 | false | 
| Lot Batch | true | 
| Serial Number | false | 
| Manufacturing Date | false | 
| Expiration Date | false | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | false | 
| RX Perscription | true | 
| OTC Over-The-Counter | false | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00887868269943 [Primary] | 
| HIBCC | M543CM7300 [Previous] | 
| LXH | Orthopedic Manual Surgical Instrument | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[00887868269943]
Moist Heat or Steam Sterilization
[00887868269943]
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[00887868269943]
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[00887868269943]
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[00887868269943]
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[00887868269943]
Moist Heat or Steam Sterilization
[00887868269943]
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[00887868269943]
Moist Heat or Steam Sterilization
[00887868269943]
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[00887868269943]
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[00887868269943]
Moist Heat or Steam Sterilization
[00887868269943]
Moist Heat or Steam Sterilization
[00887868269943]
Moist Heat or Steam Sterilization
[00887868269943]
Moist Heat or Steam Sterilization
[00887868269943]
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[00887868269943]
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[00887868269943]
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[00887868269943]
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[00887868269943]
Moist Heat or Steam Sterilization
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2020-09-29 | 
| Device Publish Date | 2020-09-21 | 
| M543CM7611 | CM-7611 | 
| M543CM7610 | CM-7610 | 
| M543CM7609 | CM-7609 | 
| M543CM7311 | CM-7311 | 
| M543CM7310 | CM-7310 | 
| M543CM7309 | CM-7309 | 
| M543CM7308 | CM-7308 | 
| M543CM7307 | CM-7307 | 
| M543CM7300 | CM-7300 | 
| M543CM7270 | CM-7270 | 
| M543CM7260 | CM-7260 | 
| M543CM7255 | CM-7255 | 
| M543CM7250 | CM-7250 | 
| M543CM7211 | CM-7211 | 
| M543CM7210 | CM-7210 | 
| M543CM7209 | CM-7209 | 
| M543CM7208 | CM-7208 | 
| M543CM7207 | CM-7207 | 
| M543CM7201 | CM-7201 | 
| M543CM7200 | CM-7200 | 
| M543CM7014 | CM-7014 | 
| M543CM7013 | CM-7013 | 
| M543CM7011 | CM-7011 | 
| M543CM7010 | CM-7010 | 
| M543CM7001 | CM-7001 | 
| M543CM7000 | CM-7000 | 
| M543CM1501 | CM-1501 | 
| M543CM7111ST1 | CM-7111ST | 
| M543CM7110ST1 | CM-7110ST | 
| M543CM7109ST1 | CM-7109ST | 
| 00887868270024 | CM-7611 | 
| 00887868270017 | CM-7610 | 
| 00887868270000 | CM-7609 | 
| 00887868269943 | CM-7300 | 
| 00887868269875 | CM-7200 | 
| 00887868269868 | CM-7111ST | 
| 00887868269851 | CM-7110ST | 
| 00887868269844 | CM-7109ST | 
| 00887868269837 | CM-7014 | 
| 00887868269820 | CM-7013 | 
| 00887868269714 | AperFix® II Cannulated Tibial Implant 11mmx30mm | 
| 00887868269707 | AperFix® II Cannulated Tibial Implant 10mmx30mm | 
| 00887868269691 | AperFix® II Cannulated Tibial Implant 9mmx30mm | 
| 00887868269684 | AperFix® Tibial Implant 8mmx30mm | 
| 00887868269677 | AperFix® Femoral Implant 11mmx29mm | 
| 00887868269660 | AperFix® Femoral Implant 10mmx29mm | 
| 00887868269653 | AperFix® Femoral Implant 9mmx29mm | 
| 00887868269639 | AperFix® II AM Femoral Implant 10mmx24mm | 
| 00887868269615 | AperFix® II AM Femoral Implant 9mmx24mm | 
| 00887868269523 | CM-1501 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  APERFIX  78780474  3442545 Live/Registered | Cayenne Medical, Inc. 2005-12-23 |