| Primary Device ID | B565FO20150 |
| NIH Device Record Key | 979365e3-2580-4197-b419-83e5efcca2a1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Orbitum Staple System |
| Version Model Number | Rev A |
| Catalog Number | FO-2015 |
| Company DUNS | 017138000 |
| Company Name | CPM MEDICAL CONSULTANTS, LLC |
| 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 | 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 |
| Phone | 972-331-5860 |
| xx@xx.xx | |
| Phone | 972-331-5860 |
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| Phone | 972-331-5860 |
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| Phone | 972-331-5860 |
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| Phone | 972-331-5860 |
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| Phone | 972-331-5860 |
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| Phone | 972-331-5860 |
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| Phone | 972-331-5860 |
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| Phone | 972-331-5860 |
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| Phone | 972-331-5860 |
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| Phone | 972-331-5860 |
| xx@xx.xx | |
| Phone | 972-331-5860 |
| xx@xx.xx | |
| Phone | 972-331-5860 |
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| Phone | 972-331-5860 |
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| Phone | 972-331-5860 |
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| Phone | 972-331-5860 |
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| Phone | 972-331-5860 |
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| Phone | 972-331-5860 |
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| Phone | 972-331-5860 |
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| Phone | 972-331-5860 |
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| Phone | 972-331-5860 |
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| Phone | 972-331-5860 |
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| Phone | 972-331-5860 |
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| Phone | 972-331-5860 |
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| Phone | 972-331-5860 |
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| Phone | 972-331-5860 |
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| Phone | 972-331-5860 |
| xx@xx.xx | |
| Phone | 972-331-5860 |
| xx@xx.xx | |
| Phone | 972-331-5860 |
| xx@xx.xx | |
| Phone | 972-331-5860 |
| xx@xx.xx | |
| Phone | 972-331-5860 |
| xx@xx.xx | |
| Phone | 972-331-5860 |
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| Phone | 972-331-5860 |
| xx@xx.xx | |
| Phone | 972-331-5860 |
| xx@xx.xx | |
| Phone | 972-331-5860 |
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| Phone | 972-331-5860 |
| xx@xx.xx | |
| Phone | 972-331-5860 |
| xx@xx.xx | |
| Phone | 972-331-5860 |
| xx@xx.xx | |
| Phone | 972-331-5860 |
| xx@xx.xx |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B565FO20150 [Primary] |
| JDR | Staple, Fixation, Bone |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B565FO20150]
Moist Heat or Steam Sterilization
[B565FO20150]
Moist Heat or Steam Sterilization
[B565FO20150]
Moist Heat or Steam Sterilization
[B565FO20150]
Moist Heat or Steam Sterilization
[B565FO20150]
Moist Heat or Steam Sterilization
[B565FO20150]
Moist Heat or Steam Sterilization
[B565FO20150]
Moist Heat or Steam Sterilization
[B565FO20150]
Moist Heat or Steam Sterilization
[B565FO20150]
Moist Heat or Steam Sterilization
[B565FO20150]
Moist Heat or Steam Sterilization
[B565FO20150]
Moist Heat or Steam Sterilization
[B565FO20150]
Moist Heat or Steam Sterilization
[B565FO20150]
Moist Heat or Steam Sterilization
[B565FO20150]
Moist Heat or Steam Sterilization
[B565FO20150]
Moist Heat or Steam Sterilization
[B565FO20150]
Moist Heat or Steam Sterilization
[B565FO20150]
Moist Heat or Steam Sterilization
[B565FO20150]
Moist Heat or Steam Sterilization
[B565FO20150]
Moist Heat or Steam Sterilization
[B565FO20150]
Moist Heat or Steam Sterilization
[B565FO20150]
Moist Heat or Steam Sterilization
[B565FO20150]
Moist Heat or Steam Sterilization
[B565FO20150]
Moist Heat or Steam Sterilization
[B565FO20150]
Moist Heat or Steam Sterilization
[B565FO20150]
Moist Heat or Steam Sterilization
[B565FO20150]
Moist Heat or Steam Sterilization
[B565FO20150]
Moist Heat or Steam Sterilization
[B565FO20150]
Moist Heat or Steam Sterilization
[B565FO20150]
Moist Heat or Steam Sterilization
[B565FO20150]
Moist Heat or Steam Sterilization
[B565FO20150]
Moist Heat or Steam Sterilization
[B565FO20150]
Moist Heat or Steam Sterilization
[B565FO20150]
Moist Heat or Steam Sterilization
[B565FO20150]
Moist Heat or Steam Sterilization
[B565FO20150]
Moist Heat or Steam Sterilization
[B565FO20150]
Moist Heat or Steam Sterilization
[B565FO20150]
Moist Heat or Steam Sterilization
[B565FO20150]
Moist Heat or Steam Sterilization
[B565FO20150]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-04-26 |
| Device Publish Date | 2021-04-16 |
| B565FO20150 | Clinical Sizer |
| B565FO20060 | Drill Template |
| B565FO2004200 | 20mm Punch |
| B565FO2004160 | 16mm Punch |
| B565FO2004120 | 12mm Punch |
| B565FO20030 | Tamp |
| B565FO2002200 | 20mm Inserter |
| B565FO2002160 | 16mm Inserter |
| B565FO2002120 | 12mm Inserter |
| B565FO20010 | 1.5mm Drill |
| B565FO20162060 | 2.0 MM K-WIRE, 6 INCH LENGTH, TROCAR-TROCAR |
| B565FO20161660 | 1.6 MM K-WIRE, 6 INCH LENGTH, TROCAR-TROCAR |
| B565FO20161160 | 1.1 MM K-WIRE, 6 INCH LENGTH, TROCAR-TROCAR |
| B565FO20160960 | 0.90 MM K-WIRE, 6 INCH LENGTH, TROCAR-TROCAR |
| B565FO20132060 | 2.0 MM K-WIRE, 6 INCH LENGTH, TROCAR-BLUNT |
| B565FO20131660 | 1.6 MM K-WIRE, 6 INCH LENGTH, TROCAR-BLUNT |
| B565FO20131160 | 1.1 MM K-WIRE, 6 INCH LENGTH, TROCAR-BLUNT |
| B565FO20130960 | 0.90 MM K-WIRE, 6 INCH LENGTH, TROCAR-BLUNT |
| B565FO20142091 | 2.0 mm K-Wire, 9 Inch Length, Trocar-Blunt-Olive |
| B565FO20142061 | 2.0 mm K-Wire, 6 Inch Length, Trocar-Blunt-Olive |
| B565FO20141661 | 1.6 mm K-Wire, 6 Inch Length, Trocar-Blunt-Olive |
| B565FO20141161 | 1.1 mm K-Wire, 6 Inch Length, Trocar-Blunt-Olive |
| B565FO20140961 | 0.9 mm K-Wire, 6 Inch Length, Trocar-Blunt-Olive |
| B565FO2007201 | Punch VI 20mm |
| B565FO2007161 | Punch VI 16mm |
| B565FO2007121 | Punch VI 12mm |
| B565FO2020201 | 20MM STAPLE DRILL W/ STOPS |
| B565FO2020161 | 16MM STAPLE DRILL W/ STOPS |
| B565FO2020121 | 12mm STAPLE DRILL W/ STOPS |
| B565FO20212001 | 20MM Planer |
| B565FO20211601 | 16MM Planer |
| B565FO20211201 | 12MM Planer |