Cyclops Anterior Cervical Plate System 0220-1017T

GUDID 00842048121527

1-Level Plate, Size 17

DEGEN MEDICAL, INC.

Spinal fixation plate, non-bioabsorbable
Primary Device ID00842048121527
NIH Device Record Key0f576de8-2098-4f6d-9a6b-14e2217323d8
Commercial Distribution StatusIn Commercial Distribution
Brand NameCyclops Anterior Cervical Plate System
Version Model Number0220-1017T
Catalog Number0220-1017T
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
Phone+1(877)240-7838
Emailcustomerservice@degenmedical.com
Phone+1(877)240-7838
Emailcustomerservice@degenmedical.com
Phone+1(877)240-7838
Emailcustomerservice@degenmedical.com
Phone+1(877)240-7838
Emailcustomerservice@degenmedical.com
Phone+1(877)240-7838
Emailcustomerservice@degenmedical.com
Phone+1(877)240-7838
Emailcustomerservice@degenmedical.com
Phone+1(877)240-7838
Emailcustomerservice@degenmedical.com
Phone+1(877)240-7838
Emailcustomerservice@degenmedical.com
Phone+1(877)240-7838
Emailcustomerservice@degenmedical.com
Phone+1(877)240-7838
Emailcustomerservice@degenmedical.com
Phone+1(877)240-7838
Emailcustomerservice@degenmedical.com
Phone+1(877)240-7838
Emailcustomerservice@degenmedical.com
Phone+1(877)240-7838
Emailcustomerservice@degenmedical.com

Device Dimensions

Length17 Millimeter
Length17 Millimeter
Length17 Millimeter
Length17 Millimeter
Length17 Millimeter
Length17 Millimeter
Length17 Millimeter
Length17 Millimeter
Length17 Millimeter
Length17 Millimeter
Length17 Millimeter
Length17 Millimeter
Length17 Millimeter
Length17 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100842048121527 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, fixation, spinal intervertebral body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00842048121527]

Moist Heat or Steam Sterilization

[00842048121527]

Moist Heat or Steam Sterilization

[00842048121527]

Moist Heat or Steam Sterilization

[00842048121527]

Moist Heat or Steam Sterilization

[00842048121527]

Moist Heat or Steam Sterilization

[00842048121527]

Moist Heat or Steam Sterilization

[00842048121527]

Moist Heat or Steam Sterilization

[00842048121527]

Moist Heat or Steam Sterilization

[00842048121527]

Moist Heat or Steam Sterilization

[00842048121527]

Moist Heat or Steam Sterilization

[00842048121527]

Moist Heat or Steam Sterilization

[00842048121527]

Moist Heat or Steam Sterilization

[00842048121527]

Moist Heat or Steam Sterilization

[00842048121527]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-09-19
Device Publish Date2019-09-11

On-Brand Devices [Cyclops Anterior Cervical Plate System]

00842048122432Screw, Self Drilling, 4.25, Variable
00842048122425Screw, Self Drilling, 4.25, Fixed
00842048122418Screw, Self Drilling, 4.25, Variable
00842048122401Screw, Self Drilling, 4.25, Fixed
00842048122395Screw, Self Drilling, 4.25, Variable
00842048122388Screw, Self Drilling, 4.25, Fixed
00842048122371Screw, Self Drilling, 4.25, Variable
00842048122364Screw, Self Drilling, 4.25, Fixed
00842048122357Screw, Self Drilling, 4.25, Variable
00842048122340Screw, Self Drilling, 4.25, Fixed
00842048122333Screw, Self Drilling, 4.25, Variable
00842048122326Screw, Self Drilling, 4.25, Fixed
00842048122319Screw, Self Drilling, 4.25, Variable
00842048122302Screw, Self Drilling, 4.25, Fixed
00842048122296Screw, Self Drilling, 4.25, Variable
00842048122289Screw, Self Drilling, 4.25, Fixed
00842048122272Screw, Self Drilling, 4.25, Variable
00842048122265Screw, Self Drilling, 4.25, Fixed
00842048122258Screw, Self Drilling, 4.25, Variable
00842048122241Screw, Self Drilling, 4.25, Fixed
00842048122234Screw, Self Drilling, 4.25, Variable
00842048122227Screw, Self Drilling, 4.25, Fixed
00842048122210Screw, Self Drilling, 4.0, Variable
00842048122203Screw, Self Drilling, 4.0, Fixed
00842048122197Screw, Self Drilling, 4.0, Variable
00842048122180Screw, Self Drilling, 4.0, Fixed
00842048122173Screw, Self Drilling, 4.0, Variable
00842048122166Screw, Self Drilling, 4.0, Fixed
00842048122159Screw, Self Drilling, 4.0, Variable
00842048122142Screw, Self Drilling, 4.0, Fixed
00842048122135Screw, Self Drilling, 4.0, Variable
00842048122128Screw, Self Drilling, 4.0, Fixed
00842048122111Screw, Self Drilling, 4.0, Variable
00842048122104Screw, Self Drilling, 4.0, Fixed
00842048122098Screw, Self Drilling, 4.0, Variable
00842048122081Screw, Self Drilling, 4.0, Fixed
00842048122074Screw, Self Drilling, 4.0, Variable
00842048122067Screw, Self Drilling, 4.0, Fixed
00842048122050Screw, Self Drilling, 4.0, Variable
00842048122043Screw, Self Drilling, 4.0, Fixed
00842048122036Screw, Self Drilling, 4.0, Variable
00842048122029Screw, Self Drilling, 4.0, Fixed
00842048122012Screw, Self Drilling, 4.0, Variable
00842048122005Screw, Self Drilling, 4.0, Fixed
008420481219925-Level Plate, Size 113
008420481219855-Level Plate, Size 108
008420481219785-Level Plate, Size 103
008420481219615-Level Plate, Size 98
008420481219545-Level Plate, Size 93
008420481219475-Level Plate, Size 88
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