SImmetry, 11mm Drill

GUDID 04260636673689

Paradigm Spine GmbH

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Primary Device ID04260636673689
NIH Device Record Key6a58d59c-837a-4b81-b652-3298c8a22bc2
Commercial Distribution StatusIn Commercial Distribution
Brand NameSImmetry, 11mm Drill
Version Model NumberZYG-10106
Company DUNS537619731
Company NameParadigm Spine GmbH
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 Usefalse
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
GS104260636673689 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OURSacroiliac Joint Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04260636673689]

Moist Heat or Steam Sterilization


[04260636673689]

Moist Heat or Steam Sterilization


[04260636673689]

Moist Heat or Steam Sterilization


[04260636673689]

Moist Heat or Steam Sterilization


[04260636673689]

Moist Heat or Steam Sterilization


[04260636673689]

Moist Heat or Steam Sterilization


[04260636673689]

Moist Heat or Steam Sterilization


[04260636673689]

Moist Heat or Steam Sterilization


[04260636673689]

Moist Heat or Steam Sterilization


[04260636673689]

Moist Heat or Steam Sterilization


[04260636673689]

Moist Heat or Steam Sterilization


[04260636673689]

Moist Heat or Steam Sterilization


[04260636673689]

Moist Heat or Steam Sterilization


[04260636673689]

Moist Heat or Steam Sterilization


[04260636673689]

Moist Heat or Steam Sterilization


[04260636673689]

Moist Heat or Steam Sterilization


[04260636673689]

Moist Heat or Steam Sterilization


[04260636673689]

Moist Heat or Steam Sterilization


[04260636673689]

Moist Heat or Steam Sterilization


[04260636673689]

Moist Heat or Steam Sterilization


[04260636673689]

Moist Heat or Steam Sterilization


[04260636673689]

Moist Heat or Steam Sterilization


[04260636673689]

Moist Heat or Steam Sterilization


[04260636673689]

Moist Heat or Steam Sterilization


[04260636673689]

Moist Heat or Steam Sterilization


[04260636673689]

Moist Heat or Steam Sterilization


[04260636673689]

Moist Heat or Steam Sterilization


[04260636673689]

Moist Heat or Steam Sterilization


[04260636673689]

Moist Heat or Steam Sterilization


[04260636673689]

Moist Heat or Steam Sterilization


[04260636673689]

Moist Heat or Steam Sterilization


[04260636673689]

Moist Heat or Steam Sterilization


[04260636673689]

Moist Heat or Steam Sterilization


[04260636673689]

Moist Heat or Steam Sterilization


[04260636673689]

Moist Heat or Steam Sterilization


[04260636673689]

Moist Heat or Steam Sterilization


[04260636673689]

Moist Heat or Steam Sterilization


[04260636673689]

Moist Heat or Steam Sterilization


[04260636673689]

Moist Heat or Steam Sterilization


[04260636673689]

Moist Heat or Steam Sterilization


[04260636673689]

Moist Heat or Steam Sterilization


[04260636673689]

Moist Heat or Steam Sterilization


[04260636673689]

Moist Heat or Steam Sterilization


[04260636673689]

Moist Heat or Steam Sterilization


[04260636673689]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-02
Device Publish Date2021-01-25

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