Rod Reducer 2 Adaptor Medical Device Identification

GUDID 08800048402376

Rod Reducer 2 Adaptor

Medyssey Co., Ltd.

Orthopaedic rod reducer

Primary Device ID	08800048402376
NIH Device Record Key	318ff6dd-7fcc-4569-955c-0b828fe67000
Commercial Distribution Status	In Commercial Distribution
Version Model Number	NCRA-002
Company DUNS	688211503
Company Name	Medyssey Co., Ltd.
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	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800048402376 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K232218

FDA Product Code

LXH	Orthopedic manual surgical instrument

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[08800048402376]

Moist Heat or Steam Sterilization

[08800048402376]

Moist Heat or Steam Sterilization

[08800048402376]

Moist Heat or Steam Sterilization

[08800048402376]

Moist Heat or Steam Sterilization

[08800048402376]

Moist Heat or Steam Sterilization

[08800048402376]

Moist Heat or Steam Sterilization

[08800048402376]

Moist Heat or Steam Sterilization

[08800048402376]

Moist Heat or Steam Sterilization

[08800048402376]

Moist Heat or Steam Sterilization

[08800048402376]

Moist Heat or Steam Sterilization

[08800048402376]

Moist Heat or Steam Sterilization

[08800048402376]

Moist Heat or Steam Sterilization

[08800048402376]

Moist Heat or Steam Sterilization

[08800048402376]

Moist Heat or Steam Sterilization

[08800048402376]

Moist Heat or Steam Sterilization

[08800048402376]

Moist Heat or Steam Sterilization

[08800048402376]

Moist Heat or Steam Sterilization

[08800048402376]

Moist Heat or Steam Sterilization

[08800048402376]

Moist Heat or Steam Sterilization

[08800048402376]

Moist Heat or Steam Sterilization

[08800048402376]

Moist Heat or Steam Sterilization

[08800048402376]

Moist Heat or Steam Sterilization

[08800048402376]

Moist Heat or Steam Sterilization

[08800048402376]

Moist Heat or Steam Sterilization

[08800048402376]

Moist Heat or Steam Sterilization

[08800048402376]

Moist Heat or Steam Sterilization

[08800048402376]

Moist Heat or Steam Sterilization

[08800048402376]

Moist Heat or Steam Sterilization

[08800048402376]

Moist Heat or Steam Sterilization

[08800048402376]

Moist Heat or Steam Sterilization

[08800048402376]

Moist Heat or Steam Sterilization

[08800048402376]

Moist Heat or Steam Sterilization

[08800048402376]

Moist Heat or Steam Sterilization

[08800048402376]

Moist Heat or Steam Sterilization

[08800048402376]

Moist Heat or Steam Sterilization

[08800048402376]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2023-09-28
Device Publish Date	2023-09-20

Devices Manufactured by Medyssey Co., Ltd.

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08800311596481 - Medyssey Poseidon OCT Spinal Fixation System	2026-02-09 Poseidon Straight Titanium Rod, Ø3.5mm, 65mm Length
08800311596498 - Medyssey Poseidon OCT Spinal Fixation System	2026-02-09 Poseidon Straight Titanium Rod, Ø3.5mm, 75mm Length
08800311596504 - Medyssey Poseidon OCT Spinal Fixation System	2026-02-09 Poseidon Straight Titanium Rod, Ø3.5mm, 85mm Length
08800311596511 - Medyssey Poseidon OCT Spinal Fixation System	2026-02-09 Poseidon Straight Titanium Rod, Ø3.5mm, 95mm Length
08800311596528 - Medyssey Poseidon OCT Spinal Fixation System	2026-02-09 Poseidon Straight Titanium Rod, Ø3.5mm, 105mm Length
08800311596535 - Medyssey Poseidon OCT Spinal Fixation System	2026-02-09 Poseidon Straight Titanium Rod, Ø3.5mm, 115mm Length
08800311596542 - Medyssey Poseidon OCT Spinal Fixation System	2026-02-09 Poseidon Straight Titanium Rod, Ø3.5mm, 125mm Length

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