Prase MIS Spinal Fixation System

GUDID 08800033182504

GBS Commonwealth Co.,Ltd.

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile
Primary Device ID08800033182504
NIH Device Record Key11463c26-99bb-49fe-81df-b7512722b2b5
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrase MIS Spinal Fixation System
Version Model NumberAB1248
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
GS108800033182504 [Primary]

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800033182504]

Moist Heat or Steam Sterilization


[08800033182504]

Moist Heat or Steam Sterilization


[08800033182504]

Moist Heat or Steam Sterilization


[08800033182504]

Moist Heat or Steam Sterilization


[08800033182504]

Moist Heat or Steam Sterilization


[08800033182504]

Moist Heat or Steam Sterilization


[08800033182504]

Moist Heat or Steam Sterilization


[08800033182504]

Moist Heat or Steam Sterilization


[08800033182504]

Moist Heat or Steam Sterilization


[08800033182504]

Moist Heat or Steam Sterilization


[08800033182504]

Moist Heat or Steam Sterilization


[08800033182504]

Moist Heat or Steam Sterilization


[08800033182504]

Moist Heat or Steam Sterilization


[08800033182504]

Moist Heat or Steam Sterilization


[08800033182504]

Moist Heat or Steam Sterilization


[08800033182504]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-24
Device Publish Date2021-02-16

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