Primary Device ID | 00193082156342 |
NIH Device Record Key | def2d973-348c-45bb-be48-64b4d74173de |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ASTRA Spine System |
Version Model Number | A6H-B50 |
Catalog Number | A6H-B50 |
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 | |
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 | 00193082156342 [Primary] |
KWQ | Appliance, fixation, spinal intervertebral body |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00193082156342]
Moist Heat or Steam Sterilization
[00193082156342]
Moist Heat or Steam Sterilization
[00193082156342]
Moist Heat or Steam Sterilization
[00193082156342]
Moist Heat or Steam Sterilization
[00193082156342]
Moist Heat or Steam Sterilization
[00193082156342]
Moist Heat or Steam Sterilization
[00193082156342]
Moist Heat or Steam Sterilization
[00193082156342]
Moist Heat or Steam Sterilization
[00193082156342]
Moist Heat or Steam Sterilization
[00193082156342]
Moist Heat or Steam Sterilization
[00193082156342]
Moist Heat or Steam Sterilization
[00193082156342]
Moist Heat or Steam Sterilization
[00193082156342]
Moist Heat or Steam Sterilization
[00193082156342]
Moist Heat or Steam Sterilization
[00193082156342]
Moist Heat or Steam Sterilization
[00193082156342]
Moist Heat or Steam Sterilization
[00193082156342]
Moist Heat or Steam Sterilization
[00193082156342]
Moist Heat or Steam Sterilization
[00193082156342]
Moist Heat or Steam Sterilization
[00193082156342]
Moist Heat or Steam Sterilization
[00193082156342]
Moist Heat or Steam Sterilization
[00193082156342]
Moist Heat or Steam Sterilization
[00193082156342]
Moist Heat or Steam Sterilization
[00193082156342]
Moist Heat or Steam Sterilization
[00193082156342]
Moist Heat or Steam Sterilization
[00193082156342]
Moist Heat or Steam Sterilization
[00193082156342]
Moist Heat or Steam Sterilization
[00193082156342]
Moist Heat or Steam Sterilization
[00193082156342]
Moist Heat or Steam Sterilization
[00193082156342]
Moist Heat or Steam Sterilization
[00193082156342]
Moist Heat or Steam Sterilization
[00193082156342]
Moist Heat or Steam Sterilization
[00193082156342]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-02-20 |
Device Publish Date | 2023-02-10 |
00193082052507 | ASTRA DIA. 5.5mm Ti Straight Rod, 30mm |
00193082112430 | ASTRA Extra Short Dia.7.00mm Tap - Trilobe End |
00193082112423 | ASTRA Extra Short Dia.6.50mm Tap - Trilobe End |
00193082112416 | ASTRA Extra Short Dia.6.00mm Tap - Trilobe End |
00193082112409 | ASTRA Extra Short Dia.5.50mm Tap - Trilobe End |
00193082112393 | ASTRA Extra Short Dia.5.00mm Tap - Trilobe End |
00193082112386 | ASTRA Extra Short Dia.4.50mm Tap - Trilobe End |
00193082112379 | ASTRA Extra Short Dia.4.00mm Tap - Trilobe End |
00193082112362 | ASTRA Extra Short Polyaxial Screwdriver Sleeve |
00193082112355 | ASTRA Extra Short Polyaxial Screwdriver Shaft, Trilobe End |
00193082112348 | ASTRA Extra Short Dedicated Reduction Polyaxial Screwdriver Shaft, Trilobe End |
00193082112331 | ASTRA Cannulated Dedicated Reduction Polyaxial Screwdriver |
00193082112324 | ASTRA Cannulated Regular Polyaxial Screwdriver |
00193082077081 | Dia.7 and Dia.7.5mm Reduction Uniplanar Screws Caddy |
00193082077074 | Dia.5.5mm and 6mm Reduction Uniplanar Screws Caddy |
00193082077067 | Dia.4.5mm and 5.5mm Reduction Uniplanar Screws Caddy |
00193082077050 | Miscellaneous Implants Caddy |
00193082077043 | Dia.7 and Dia.7.5mm Reduction Polyaxial Screws Caddy |
00193082077036 | Dia.5.5mm and 6mm Reduction Polyaxial Screws Caddy |
00193082077029 | Dia.4.5mm and 5.5mm Reduction Polyaxial Screws Caddy |
00193082077012 | Uniplanar Screw Caddy 2 |
00193082077005 | Uniplanar Screw Caddy 1 |
00193082076992 | Uniplanar Implant Case |
00193082076985 | Deformity Polyaxial Screw Caddy 2 |
00193082076978 | Deformity Polyaxial Screw Caddy 1 |
00193082076961 | Large Polyaxial Screws and Iliac Connectors Caddy |
00193082076954 | Hooks Caddy |
00193082076947 | Regular and Large Set Screws Caddy |
00193082076930 | ASTRA Deformity Implants Case -Case and Lid Only- |
00193082076923 | Degenerative Polyaxial Screw Caddy |
00193082076916 | Degenerative Polyaxial Screw Caddy |
00193082076909 | Dia.6.25 and Dia.7mm Reduction Polyaxial Screws Caddy |
00193082076893 | Regular and large Set Screws Caddy |
00193082076886 | ASTRA Degenerative Implants Case -Case and Lid Only- |
00193082076879 | Derotation Tube |
00193082076862 | Reduction Tab Protector |
00193082076855 | ASTRA Long Rocker- No Handle |
00193082076831 | Rod Rotation Wrench, 5.5mm/6.0mm Hex-end Rods |
00193082076824 | Dia.6.5mm Firefly Tap - 1/4in square end |
00193082076817 | Dia.6.0mm Firefly Tap - 1/4in square end |
00193082076800 | Dia.5.50mm Firefly Tap - 1/4in square end |
00193082076794 | Dia.5.00mm Firefly Tap - 1/4in square end |
00193082076787 | Dia.4.50mm Firefly Tap - 1/4in square end |
00193082076770 | Dia.4.00mm Firefly Tap - 1/4in square end |
00193082076763 | ASTRA Vertebral Body Derotation Instruments Case |
00193082076756 | Cross Connector Anti-Torque |
00193082076749 | T22 Self-Retaining Driver with Dedicated Handle |
00193082076732 | Cross Connector Holder Forceps |
00193082076725 | ASTRA Cross Connector Caddy |
00193082076718 | ASTRA Cross Connector Implants and Instrument Case |