PRASE-C Anterior Cervical Plate System

GUDID 08800113313842

GBS Commonwealth Co.,Ltd.

Spinal fixation plate, non-bioabsorbable
Primary Device ID08800113313842
NIH Device Record Key200f56c4-5417-439c-9ee8-7a14fceec81a
Commercial Distribution StatusIn Commercial Distribution
Brand NamePRASE-C Anterior Cervical Plate System
Version Model NumberC128-4226
Company DUNS694609156
Company NameGBS Commonwealth Co.,Ltd.
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800113313842 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800113313842]

Moist Heat or Steam Sterilization


[08800113313842]

Moist Heat or Steam Sterilization


[08800113313842]

Moist Heat or Steam Sterilization


[08800113313842]

Moist Heat or Steam Sterilization


[08800113313842]

Moist Heat or Steam Sterilization


[08800113313842]

Moist Heat or Steam Sterilization


[08800113313842]

Moist Heat or Steam Sterilization


[08800113313842]

Moist Heat or Steam Sterilization


[08800113313842]

Moist Heat or Steam Sterilization


[08800113313842]

Moist Heat or Steam Sterilization


[08800113313842]

Moist Heat or Steam Sterilization


[08800113313842]

Moist Heat or Steam Sterilization


[08800113313842]

Moist Heat or Steam Sterilization


[08800113313842]

Moist Heat or Steam Sterilization


[08800113313842]

Moist Heat or Steam Sterilization


[08800113313842]

Moist Heat or Steam Sterilization


[08800113313842]

Moist Heat or Steam Sterilization


[08800113313842]

Moist Heat or Steam Sterilization


[08800113313842]

Moist Heat or Steam Sterilization


[08800113313842]

Moist Heat or Steam Sterilization


[08800113313842]

Moist Heat or Steam Sterilization


[08800113313842]

Moist Heat or Steam Sterilization


[08800113313842]

Moist Heat or Steam Sterilization


[08800113313842]

Moist Heat or Steam Sterilization


[08800113313842]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-03-08
Device Publish Date2021-02-28

On-Brand Devices [PRASE-C Anterior Cervical Plate System]

08800113313842C128-4226
08800113313835C128-4225
08800113313828C128-4224
08800113313811C128-4223
08800113313804C128-4222
08800113313798C128-4221
08800113313781C128-4220
08800113313774C128-4219
08800113313767C128-4218
08800113313750C128-4217
08800113313743C128-4216
08800113313736C128-4215
08800113313729C128-4214
08800113313712C128-4213
08800113313705C128-4212
08800113313699C128-4211
08800113313682C128-4210
08800113313675C128-3726
08800113313668C128-3725
08800113313651C128-3724
08800113313644C128-3723
08800113313637C128-3722
08800113313620C128-3721
08800113313613C128-3720
08800113313606C128-3719
08800113313590C128-3718
08800113313583C128-3717
08800113313576C128-3716
08800113313569C128-3715
08800113313552C128-3714
08800113313545C128-3713
08800113313538C128-3712
08800113313521C128-3711
08800113313514C128-3710
08800113313507C127-4226
08800113313491C127-4225
08800113313484C127-4224
08800113313477C127-4223
08800113313460C127-4222
08800113313453C127-4221
08800113313446C127-4220
08800113313439C127-4219
08800113313422C127-4218
08800113313415C127-4217
08800113313408C127-4216
08800113313392C127-4215
08800113313385C127-4214
08800113313378C127-4213
08800113313361C127-4212
08800113313354C127-4211

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