ASTRA Spine System 6500-100-N

GUDID 00193082113130

PSO Core Set Sterilization Case

SPINECRAFT, LLC

General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit
Primary Device ID00193082113130
NIH Device Record Key307072e6-2fd2-4011-b7f2-a0a465c61390
Commercial Distribution StatusIn Commercial Distribution
Brand NameASTRA Spine System
Version Model Number6500-100-N
Catalog Number6500-100-N
Company DUNS783908713
Company NameSPINECRAFT, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(630)920-7300
Emailinfo@spinecraft.com
Phone+1(630)920-7300
Emailinfo@spinecraft.com
Phone+1(630)920-7300
Emailinfo@spinecraft.com
Phone+1(630)920-7300
Emailinfo@spinecraft.com
Phone+1(630)920-7300
Emailinfo@spinecraft.com
Phone+1(630)920-7300
Emailinfo@spinecraft.com
Phone+1(630)920-7300
Emailinfo@spinecraft.com
Phone+1(630)920-7300
Emailinfo@spinecraft.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100193082113130 [Primary]
GS100193082113130 [Primary]
GS100193082113130 [Primary]
GS100193082113130 [Primary]
GS100193082113130 [Primary]
GS100193082113130 [Primary]
GS100193082113130 [Primary]
GS100193082113130 [Primary]

FDA Product Code

LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00193082113130]

Moist Heat or Steam Sterilization


[00193082113130]

Moist Heat or Steam Sterilization


[00193082113130]

Moist Heat or Steam Sterilization


[00193082113130]

Moist Heat or Steam Sterilization


[00193082113130]

Moist Heat or Steam Sterilization


[00193082113130]

Moist Heat or Steam Sterilization


[00193082113130]

Moist Heat or Steam Sterilization


[00193082113130]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-09
Device Publish Date2020-10-30

On-Brand Devices [ASTRA Spine System]

00193082052507ASTRA DIA. 5.5mm Ti Straight Rod, 30mm
00193082112430ASTRA Extra Short Dia.7.00mm Tap - Trilobe End
00193082112423ASTRA Extra Short Dia.6.50mm Tap - Trilobe End
00193082112416ASTRA Extra Short Dia.6.00mm Tap - Trilobe End
00193082112409ASTRA Extra Short Dia.5.50mm Tap - Trilobe End
00193082112393ASTRA Extra Short Dia.5.00mm Tap - Trilobe End
00193082112386ASTRA Extra Short Dia.4.50mm Tap - Trilobe End
00193082112379ASTRA Extra Short Dia.4.00mm Tap - Trilobe End
00193082112362ASTRA Extra Short Polyaxial Screwdriver Sleeve
00193082112355ASTRA Extra Short Polyaxial Screwdriver Shaft, Trilobe End
00193082112348ASTRA Extra Short Dedicated Reduction Polyaxial Screwdriver Shaft, Trilobe End
00193082112331ASTRA Cannulated Dedicated Reduction Polyaxial Screwdriver
00193082112324ASTRA Cannulated Regular Polyaxial Screwdriver
00193082077081Dia.7 and Dia.7.5mm Reduction Uniplanar Screws Caddy
00193082077074Dia.5.5mm and 6mm Reduction Uniplanar Screws Caddy
00193082077067Dia.4.5mm and 5.5mm Reduction Uniplanar Screws Caddy
00193082077050Miscellaneous Implants Caddy
00193082077043Dia.7 and Dia.7.5mm Reduction Polyaxial Screws Caddy
00193082077036Dia.5.5mm and 6mm Reduction Polyaxial Screws Caddy
00193082077029Dia.4.5mm and 5.5mm Reduction Polyaxial Screws Caddy
00193082077012Uniplanar Screw Caddy 2
00193082077005Uniplanar Screw Caddy 1
00193082076992Uniplanar Implant Case
00193082076985Deformity Polyaxial Screw Caddy 2
00193082076978Deformity Polyaxial Screw Caddy 1
00193082076961Large Polyaxial Screws and Iliac Connectors Caddy
00193082076954Hooks Caddy
00193082076947Regular and Large Set Screws Caddy
00193082076930ASTRA Deformity Implants Case -Case and Lid Only-
00193082076923Degenerative Polyaxial Screw Caddy
00193082076916Degenerative Polyaxial Screw Caddy
00193082076909Dia.6.25 and Dia.7mm Reduction Polyaxial Screws Caddy
00193082076893Regular and large Set Screws Caddy
00193082076886ASTRA Degenerative Implants Case -Case and Lid Only-
00193082076879Derotation Tube
00193082076862Reduction Tab Protector
00193082076855ASTRA Long Rocker- No Handle
00193082076831Rod Rotation Wrench, 5.5mm/6.0mm Hex-end Rods
00193082076824Dia.6.5mm Firefly Tap - 1/4in square end
00193082076817Dia.6.0mm Firefly Tap - 1/4in square end
00193082076800Dia.5.50mm Firefly Tap - 1/4in square end
00193082076794Dia.5.00mm Firefly Tap - 1/4in square end
00193082076787Dia.4.50mm Firefly Tap - 1/4in square end
00193082076770Dia.4.00mm Firefly Tap - 1/4in square end
00193082076763ASTRA Vertebral Body Derotation Instruments Case
00193082076756Cross Connector Anti-Torque
00193082076749T22 Self-Retaining Driver with Dedicated Handle
00193082076732Cross Connector Holder Forceps
00193082076725ASTRA Cross Connector Caddy
00193082076718ASTRA Cross Connector Implants and Instrument Case

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