E³ MIS Pedicle Screw System 0603-85045

GUDID 00842048120315

Screw, CC, Solid, 8.5 X 45mm

DEGEN MEDICAL, INC.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00842048120315
NIH Device Record Key5dab3457-ab6d-4df7-ab64-d23e9c5bafa1
Commercial Distribution StatusIn Commercial Distribution
Brand NameE³ MIS Pedicle Screw System
Version Model Number0603-85045
Catalog Number0603-85045
Company DUNS078812602
Company NameDEGEN MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(877)240-7838
Emailcustomerservice@degenmedical.com

Device Dimensions

Outer Diameter8.5 Millimeter
Outer Diameter8.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100842048120315 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral pedicle screw system

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00842048120315]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-04-16

On-Brand Devices [E³ MIS Pedicle Screw System]

00842048121435Mini Tower
00842048121145Rod Inserter, Straight
00842048121138Rod Inserter, Offset
00842048121121Mini Tower Reduction
00842048121114Screw, CC, Solid, 10.0 X 130mm
00842048121107Screw, CC, Solid, 10.0 X 125mm
00842048121091Screw, CC, Solid, 10.0 X 120mm
00842048121084Screw, CC, Solid, 10.0 X 115mm
00842048121077Screw, CC, Solid, 10.0 X 110mm
00842048121060Screw, CC, Solid, 10.0 X 105mm
00842048121053Screw, CC, Solid, 10.0 X 100mm
00842048121046Screw, CC, Solid, 10.0 X 95mm
00842048121039Screw, CC, Solid, 10.0 X 90mm
00842048121022Screw, CC, Solid, 10.0 X 85mm
00842048121015Screw, CC, Solid, 10.0 X 80mm
00842048121008Screw, CC, Solid, 10.0 X 75mm
00842048120995Screw, CC, Solid, 10.0 X 70mm
00842048120988Screw, CC, Solid, 10.0 X 65mm
00842048120971Screw, CC, Solid, 10.0 X 60mm
00842048120964Screw, CC, Solid, 10.0 X 55mm
00842048120957Screw, CC, Solid, 10.0 X 50mm
00842048120940Screw, CC, Solid, 10.0 X 45mm
00842048120933Screw, CC, Solid, 10.0 X 40mm
00842048120926Screw, CC, Solid, 10.0 X 35mm
00842048120919Screw, CC, Solid, 10.0 X 30mm
00842048120902Screw, CC, Solid, 9.5 X 130mm
00842048120896Screw, CC, Solid, 9.5 X 125mm
00842048120889Screw, CC, Solid, 9.5 X 120mm
00842048120872Screw, CC, Solid, 9.5 X 115mm
00842048120865Screw, CC, Solid, 9.5 X 110mm
00842048120858Screw, CC, Solid, 9.5 X 105mm
00842048120841Screw, CC, Solid, 9.5 X 100mm
00842048120834Screw, CC, Solid, 9.5 X 95mm
00842048120827Screw, CC, Solid, 9.5 X 90mm
00842048120810Screw, CC, Solid, 9.5 X 85mm
00842048120803Screw, CC, Solid, 9.5 X 80mm
00842048120797Screw, CC, Solid, 9.5 X 75mm
00842048120780Screw, CC, Solid, 9.5 X 70mm
00842048120773Screw, CC, Solid, 9.5 X 65mm
00842048120766Screw, CC, Solid, 9.5 X 60mm
00842048120759Screw, CC, Solid, 9.5 X 55mm
00842048120742Screw, CC, Solid, 9.5 X 50mm
00842048120735Screw, CC, Solid, 9.5 X 45mm
00842048120728Screw, CC, Solid, 9.5 X 40mm
00842048120711Screw, CC, Solid, 9.5 X 35mm
00842048120704Screw, CC, Solid, 9.5 X 30mm
00842048120698Screw, CC, Solid, 9.0 X 130mm
00842048120681Screw, CC, Solid, 9.0 X 125mm
00842048120674Screw, CC, Solid, 9.0 X 120mm
00842048120667Screw, CC, Solid, 9.0 X 115mm
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