113-092-E085

GUDID 04250869680141

MOSS XT Ti Pedicle Screw Ø11.0x85mm injection channel, green, cannulated DL, polyaxial

Biedermann Motech GmbH & Co. KG

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 ID04250869680141
NIH Device Record Keydeb06658-d9a1-4f1d-a91b-2f04cb020b5c
Commercial Distribution StatusIn Commercial Distribution
Version Model Number113-092-E085
Catalog Number113-092-E085
Company DUNS320249162
Company NameBiedermann Motech GmbH & Co. KG
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

Device Identifiers

Device Issuing AgencyDevice ID
GS104250869680141 [Primary]

FDA Product Code

NKBThoracolumbosacral pedicle screw system

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04250869680141]

Moist Heat or Steam Sterilization


[04250869680141]

Moist Heat or Steam Sterilization


[04250869680141]

Moist Heat or Steam Sterilization


[04250869680141]

Moist Heat or Steam Sterilization


[04250869680141]

Moist Heat or Steam Sterilization


[04250869680141]

Moist Heat or Steam Sterilization


[04250869680141]

Moist Heat or Steam Sterilization


[04250869680141]

Moist Heat or Steam Sterilization


[04250869680141]

Moist Heat or Steam Sterilization


[04250869680141]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-09-24
Device Publish Date2021-09-16

Devices Manufactured by Biedermann Motech GmbH & Co. KG

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04250869688475 - NA2023-11-30 MOSS VRS PSO Pliers Connector 50mm
04250869688482 - NA2023-11-30 MOSS VRS PSO Pliers Connector 75mm
04250869688512 - NA2023-11-30 MOSS VRS PSO Pliers connector 150mm
04250869688529 - NA2023-11-30 MOSS VRS PSO Pliers Blade right
04250869688536 - NA2023-11-30 MOSS VRS PSO Pliers Blade left
04250869688550 - NA2023-11-30 MOSS VRS PSO Valve adjustable, right
04250869688567 - NA2023-11-30 MOSS VRS PSO Valve adjustable, left

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