Primary Device ID | B565FO20131160 |
NIH Device Record Key | 49c4f612-1e83-4fcf-b2ee-8957c504885d |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Orbitum Staple System |
Version Model Number | Rev A |
Catalog Number | FO-2013-116 |
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 | true |
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 |
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 |
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 |
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 | B565FO20131160 [Primary] |
JDR | Staple, Fixation, Bone |
Steralize Prior To Use | true |
Device Is Sterile | false |
[B565FO20131160]
Moist Heat or Steam Sterilization
[B565FO20131160]
Moist Heat or Steam Sterilization
[B565FO20131160]
Moist Heat or Steam Sterilization
[B565FO20131160]
Moist Heat or Steam Sterilization
[B565FO20131160]
Moist Heat or Steam Sterilization
[B565FO20131160]
Moist Heat or Steam Sterilization
[B565FO20131160]
Moist Heat or Steam Sterilization
[B565FO20131160]
Moist Heat or Steam Sterilization
[B565FO20131160]
Moist Heat or Steam Sterilization
[B565FO20131160]
Moist Heat or Steam Sterilization
[B565FO20131160]
Moist Heat or Steam Sterilization
[B565FO20131160]
Moist Heat or Steam Sterilization
[B565FO20131160]
Moist Heat or Steam Sterilization
[B565FO20131160]
Moist Heat or Steam Sterilization
[B565FO20131160]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-04-27 |
Device Publish Date | 2021-04-19 |
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 |