Primary Device ID | 00193082107924 |
NIH Device Record Key | aaef6d02-e194-4746-b612-6613b6c17986 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ASTRA-OCT Spine System |
Version Model Number | A3P-4524R |
Catalog Number | A3P-4524R |
Company DUNS | 783908713 |
Company Name | SPINECRAFT, 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 | true |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +1(630)920-7300 |
info@spinecraft.com | |
Phone | +1(630)920-7300 |
info@spinecraft.com | |
Phone | +1(630)920-7300 |
info@spinecraft.com | |
Phone | +1(630)920-7300 |
info@spinecraft.com | |
Phone | +1(630)920-7300 |
info@spinecraft.com | |
Phone | +1(630)920-7300 |
info@spinecraft.com | |
Phone | +1(630)920-7300 |
info@spinecraft.com | |
Phone | +1(630)920-7300 |
info@spinecraft.com | |
Phone | +1(630)920-7300 |
info@spinecraft.com | |
Phone | +1(630)920-7300 |
info@spinecraft.com | |
Phone | +1(630)920-7300 |
info@spinecraft.com | |
Phone | +1(630)920-7300 |
info@spinecraft.com | |
Phone | +1(630)920-7300 |
info@spinecraft.com | |
Phone | +1(630)920-7300 |
info@spinecraft.com | |
Phone | +1(630)920-7300 |
info@spinecraft.com | |
Phone | +1(630)920-7300 |
info@spinecraft.com | |
Phone | +1(630)920-7300 |
info@spinecraft.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00193082107924 [Primary] |
KWP | APPLIANCE, FIXATION, SPINAL INTERLAMINAL |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00193082107924]
Moist Heat or Steam Sterilization
[00193082107924]
Moist Heat or Steam Sterilization
[00193082107924]
Moist Heat or Steam Sterilization
[00193082107924]
Moist Heat or Steam Sterilization
[00193082107924]
Moist Heat or Steam Sterilization
[00193082107924]
Moist Heat or Steam Sterilization
[00193082107924]
Moist Heat or Steam Sterilization
[00193082107924]
Moist Heat or Steam Sterilization
[00193082107924]
Moist Heat or Steam Sterilization
[00193082107924]
Moist Heat or Steam Sterilization
[00193082107924]
Moist Heat or Steam Sterilization
[00193082107924]
Moist Heat or Steam Sterilization
[00193082107924]
Moist Heat or Steam Sterilization
[00193082107924]
Moist Heat or Steam Sterilization
[00193082107924]
Moist Heat or Steam Sterilization
[00193082107924]
Moist Heat or Steam Sterilization
[00193082107924]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-04-01 |
Device Publish Date | 2019-03-22 |
00193082111013 | ASTRA-OCT Dia.5.0mm Occipital Bone Screw, 18mm |
00193082111006 | ASTRA-OCT Dia.5.0mm Occipital Bone Screw, 16mm |
00193082110993 | ASTRA-OCT Dia.5.0mm Occipital Bone Screw, 14mm |
00193082110986 | ASTRA-OCT Dia.5.0mm Occipital Bone Screw, 12mm |
00193082110979 | ASTRA-OCT Dia.5.0mm Occipital Bone Screw, 10mm |
00193082110962 | ASTRA-OCT Dia.5.0mm Occipital Bone Screw, 8mm |
00193082110955 | ASTRA-OCT Dia.5.0mm Occipital Bone Screw, 6mm |
00193082110948 | ASTRA-OCT Dia.4.5mm Occipital Bone Screw, 18mm |
00193082110931 | ASTRA-OCT Dia.4.5mm Occipital Bone Screw, 16mm |
00193082110924 | ASTRA-OCT Dia.4.5mm Occipital Bone Screw, 14mm |
00193082110917 | ASTRA-OCT Dia.4.5mm Occipital Bone Screw, 12mm |
00193082110900 | ASTRA-OCT Dia.4.5mm Occipital Bone Screw, 10mm |
00193082110894 | ASTRA-OCT Dia.4.5mm Occipital Bone Screw, 8mm |
00193082110887 | ASTRA-OCT Dia.4.5mm Occipital Bone Screw, 6mm |
00193082110870 | ASTRA-OCT Adjustable Occipital Plate, 48mm |
00193082110863 | ASTRA-OCT Adjustable Occipital Plate, 42mm |
00193082110856 | ASTRA-OCT Adjustable Occipital Plate, 36mm |
00193082110849 | ASTRA-OCT Adjustable Occipital Plate, 32mm |
00193082110832 | ASTRA-OCT Dia.4mm CoCr Z-Rod, 9mm Offset, 325mm |
00193082110825 | ASTRA-OCT Dia.4mm CoCr Z-Rod, 9mm Offset, 200mm |
00193082110818 | ASTRA-OCT Dia.4mm CoCr Z-Rod, 9mm Offset, 100mm |
00193082110801 | ASTRA-OCT Dia.4mm CoCr Z-Rod, 7mm Offset, 325mm |
00193082110795 | ASTRA-OCT Dia.4mm CoCr Z-Rod, 7mm Offset, 200mm |
00193082110788 | ASTRA-OCT Dia.4mm CoCr Z-Rod, 7mm Offset, 100mm |
00193082110771 | ASTRA-OCT Dia.3.5mm CoCr Z-Rod, 9mm Offset, 325mm |
00193082110764 | ASTRA-OCT Dia.3.5mm CoCr Z-Rod, 9mm Offset, 200mm |
00193082110757 | ASTRA-OCT Dia.3.5mm CoCr Z-Rod, 9mm Offset, 100mm |
00193082110740 | ASTRA-OCT Dia.3.5mm CoCr Z-Rod, 7mm Offset, 325mm |
00193082110733 | ASTRA-OCT Dia.3.5mm CoCr Z-Rod, 7mm Offset, 200mm |
00193082110726 | ASTRA-OCT Dia.3.5mm CoCr Z-Rod, 7mm Offset, 100mm |
00193082110719 | ASTRA-OCT Dia.4mm Ti Z-Rod, 9mm Offset, 325mm |
00193082110702 | ASTRA-OCT Dia.4mm Ti Z-Rod, 9mm Offset, 200mm |
00193082110696 | ASTRA-OCT Dia.4mm Ti Z-Rod, 9mm Offset, 100mm |
00193082110689 | ASTRA-OCT Dia.4mm Ti Z-Rod, 7mm Offset, 325mm |
00193082110672 | ASTRA-OCT Dia.4mm Ti Z-Rod, 7mm Offset, 200mm |
00193082110665 | ASTRA-OCT Dia.4mm Ti Z-Rod, 7mm Offset, 100mm |
00193082110658 | ASTRA-OCT Dia.3.5mm Ti Z-Rod, 9mm Offset, 325mm |
00193082110641 | ASTRA-OCT Dia.3.5mm Ti Z-Rod, 9mm Offset, 200mm |
00193082110634 | ASTRA-OCT Dia.3.5mm Ti Z-Rod, 9mm Offset, 100mm |
00193082110627 | ASTRA-OCT Dia.3.5mm Ti Z-Rod, 7mm Offset, 325mm |
00193082110610 | ASTRA-OCT Dia.3.5mm Ti Z-Rod, 7mm Offset, 200mm |
00193082110603 | ASTRA-OCT Dia.3.5mm Ti Z-Rod, 7mm Offset, 100mm |
00193082110597 | ASTRA-OCT Cable Connector |
00193082110580 | ASTRA-OCT Open Side-loading Angled Lateral Connector, 30mm |
00193082110573 | ASTRA-OCT Open Side-loading Angled Lateral Connector, 25mm |
00193082110566 | ASTRA-OCT Open Side-loading Angled Lateral Connector, 20mm |
00193082110559 | ASTRA-OCT Open Side-loading Angled Lateral Connector, 15mm |
00193082110542 | ASTRA-OCT Open Side-loading Angled Lateral Connector, 10mm |
00193082110535 | ASTRA-OCT Open Side-loading Lateral Connector, 25mm |
00193082110528 | ASTRA-OCT Open Side-loading Lateral Connector, 20mm |