SImmetry, Suction Tube

GUDID 04260636673535

Paradigm Spine GmbH

Orthopaedic prosthesis implantation instrument, reusable

Primary Device ID	04260636673535
NIH Device Record Key	4251fa2b-ddb9-4d5b-b972-4033c9fb54d1
Commercial Distribution Status	In Commercial Distribution
Brand Name	SImmetry, Suction Tube
Version Model Number	ZYG-10086
Company DUNS	537619731
Company Name	Paradigm Spine GmbH
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260636673535 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K151818

FDA Product Code

OUR	Sacroiliac Joint Fixation

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[04260636673535]

Moist Heat or Steam Sterilization

[04260636673535]

Moist Heat or Steam Sterilization

[04260636673535]

Moist Heat or Steam Sterilization

[04260636673535]

Moist Heat or Steam Sterilization

[04260636673535]

Moist Heat or Steam Sterilization

[04260636673535]

Moist Heat or Steam Sterilization

[04260636673535]

Moist Heat or Steam Sterilization

[04260636673535]

Moist Heat or Steam Sterilization

[04260636673535]

Moist Heat or Steam Sterilization

[04260636673535]

Moist Heat or Steam Sterilization

[04260636673535]

Moist Heat or Steam Sterilization

[04260636673535]

Moist Heat or Steam Sterilization

[04260636673535]

Moist Heat or Steam Sterilization

[04260636673535]

Moist Heat or Steam Sterilization

[04260636673535]

Moist Heat or Steam Sterilization

[04260636673535]

Moist Heat or Steam Sterilization

[04260636673535]

Moist Heat or Steam Sterilization

[04260636673535]

Moist Heat or Steam Sterilization

[04260636673535]

Moist Heat or Steam Sterilization

[04260636673535]

Moist Heat or Steam Sterilization

[04260636673535]

Moist Heat or Steam Sterilization

[04260636673535]

Moist Heat or Steam Sterilization

[04260636673535]

Moist Heat or Steam Sterilization

[04260636673535]

Moist Heat or Steam Sterilization

[04260636673535]

Moist Heat or Steam Sterilization

[04260636673535]

Moist Heat or Steam Sterilization

[04260636673535]

Moist Heat or Steam Sterilization

[04260636673535]

Moist Heat or Steam Sterilization

[04260636673535]

Moist Heat or Steam Sterilization

[04260636673535]

Moist Heat or Steam Sterilization

[04260636673535]

Moist Heat or Steam Sterilization

[04260636673535]

Moist Heat or Steam Sterilization

[04260636673535]

Moist Heat or Steam Sterilization

[04260636673535]

Moist Heat or Steam Sterilization

[04260636673535]

Moist Heat or Steam Sterilization

[04260636673535]

Moist Heat or Steam Sterilization

[04260636673535]

Moist Heat or Steam Sterilization

[04260636673535]

Moist Heat or Steam Sterilization

[04260636673535]

Moist Heat or Steam Sterilization

[04260636673535]

Moist Heat or Steam Sterilization

[04260636673535]

Moist Heat or Steam Sterilization

[04260636673535]

Moist Heat or Steam Sterilization

[04260636673535]

Moist Heat or Steam Sterilization

[04260636673535]

Moist Heat or Steam Sterilization

[04260636673535]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2021-02-02
Device Publish Date	2021-01-25

Devices Manufactured by Paradigm Spine GmbH

04260636678998 - coflex instrument loaner set	2023-04-10 instrument loaner set
04260636678912 - CoFix instrument loaner set	2021-06-29
04260636678929 - CoFix implant loaner set	2021-06-29
04260636673467 - SImmetry, Blunt Pin, 3.2mm	2021-02-02
04260636673474 - SImmetry, Impactor	2021-02-02
04260636673481 - SImmetry, Long Pin, 3.2mm	2021-02-02
04260636673498 - SImmetry, Short Pin, 3.2mm	2021-02-02
04260636673504 - SImmetry, Working Cannula	2021-02-02

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