Zenius II - Rod Fork Medical Device Identification

GUDID 08800042402099

Zenius II - Rod Fork

Medyssey Co., Ltd.

Orthopaedic implant inserter/extractor, reusable

Primary Device ID	08800042402099
NIH Device Record Key	4d2e6ba3-9946-435c-9813-8a5bdd1d7187
Commercial Distribution Status	In Commercial Distribution
Version Model Number	NZRF-Z01
Company DUNS	688211503
Company Name	Medyssey Co., Ltd.
Device Count	1
DM Exempt	false
Pre-market Exempt	true
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	08800042402099 [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

[08800042402099]

Moist Heat or Steam Sterilization

[08800042402099]

Moist Heat or Steam Sterilization

[08800042402099]

Moist Heat or Steam Sterilization

[08800042402099]

Moist Heat or Steam Sterilization

[08800042402099]

Moist Heat or Steam Sterilization

[08800042402099]

Moist Heat or Steam Sterilization

[08800042402099]

Moist Heat or Steam Sterilization

[08800042402099]

Moist Heat or Steam Sterilization

[08800042402099]

Moist Heat or Steam Sterilization

[08800042402099]

Moist Heat or Steam Sterilization

[08800042402099]

Moist Heat or Steam Sterilization

[08800042402099]

Moist Heat or Steam Sterilization

[08800042402099]

Moist Heat or Steam Sterilization

[08800042402099]

Moist Heat or Steam Sterilization

[08800042402099]

Moist Heat or Steam Sterilization

[08800042402099]

Moist Heat or Steam Sterilization

[08800042402099]

Moist Heat or Steam Sterilization

[08800042402099]

Moist Heat or Steam Sterilization

[08800042402099]

Moist Heat or Steam Sterilization

[08800042402099]

Moist Heat or Steam Sterilization

[08800042402099]

Moist Heat or Steam Sterilization

[08800042402099]

Moist Heat or Steam Sterilization

[08800042402099]

Moist Heat or Steam Sterilization

[08800042402099]

Moist Heat or Steam Sterilization

[08800042402099]

Moist Heat or Steam Sterilization

[08800042402099]

Moist Heat or Steam Sterilization

[08800042402099]

Moist Heat or Steam Sterilization

[08800042402099]

Moist Heat or Steam Sterilization

[08800042402099]

Moist Heat or Steam Sterilization

[08800042402099]

Moist Heat or Steam Sterilization

[08800042402099]

Moist Heat or Steam Sterilization

[08800042402099]

Moist Heat or Steam Sterilization

[08800042402099]

Moist Heat or Steam Sterilization

[08800042402099]

Moist Heat or Steam Sterilization

[08800042402099]

Moist Heat or Steam Sterilization

[08800042402099]

Moist Heat or Steam Sterilization

[08800042402099]

Moist Heat or Steam Sterilization

[08800042402099]

Moist Heat or Steam Sterilization

[08800042402099]

Moist Heat or Steam Sterilization

[08800042402099]

Moist Heat or Steam Sterilization

[08800042402099]

Moist Heat or Steam Sterilization

[08800042402099]

Moist Heat or Steam Sterilization

[08800042402099]

Moist Heat or Steam Sterilization

[08800042402099]

Moist Heat or Steam Sterilization

[08800042402099]

Moist Heat or Steam Sterilization

[08800042402099]

Moist Heat or Steam Sterilization

[08800042402099]

Moist Heat or Steam Sterilization

[08800042402099]

Moist Heat or Steam Sterilization

[08800042402099]

Moist Heat or Steam Sterilization

[08800042402099]

Moist Heat or Steam Sterilization

[08800042402099]

Moist Heat or Steam Sterilization

[08800042402099]

Moist Heat or Steam Sterilization

[08800042402099]

Moist Heat or Steam Sterilization

[08800042402099]

Moist Heat or Steam Sterilization

[08800042402099]

Moist Heat or Steam Sterilization

[08800042402099]

Moist Heat or Steam Sterilization

[08800042402099]

Moist Heat or Steam Sterilization

[08800042402099]

Moist Heat or Steam Sterilization

[08800042402099]

Moist Heat or Steam Sterilization

[08800042402099]

Moist Heat or Steam Sterilization

[08800042402099]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2023-02-14
Device Publish Date	2023-02-06

Devices Manufactured by Medyssey Co., Ltd.

08800048406671 - NA	2025-03-06 ALIF Cage Trial 15° F Type 15d 33x23x16
08800048406688 - NA	2025-03-06 ALIF Cage Trial 15° F Type 15d 33x23x14
08800048406695 - NA	2025-03-06 ALIF Cage Trial 15° F Type 15d 33x23x12
08800048406701 - NA	2025-03-06 ALIF Cage Trial 8° F Type 8d 33x23x14
08800048407142 - NA	2025-03-06 ALIF Cage Trial 8° F Type 8d 33x23x12
08800048412542 - NA	2025-03-06 ALIF Cage Trial 8° B Type 8d 33x26x12
08800048412566 - NA	2025-03-06 ALIF Cage Trial 8° B Type 8d 33x26x14
08800048412634 - NA	2025-03-06 ALIF Cage Trial 15° B Type 15d 33x26x12

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