Housing Holder (Zenius II) Medical Device Identification

GUDID 08800048402956

Housing Holder (Zenius II)

Medyssey Co., Ltd.

Orthopaedic prosthesis implantation instrument, reusable

Primary Device ID	08800048402956
NIH Device Record Key	a6211845-3426-4c66-88c4-9b11ebafb9c7
Commercial Distribution Status	In Commercial Distribution
Version Model Number	NZHH-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	08800048402956 [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

[08800048402956]

Moist Heat or Steam Sterilization

[08800048402956]

Moist Heat or Steam Sterilization

[08800048402956]

Moist Heat or Steam Sterilization

[08800048402956]

Moist Heat or Steam Sterilization

[08800048402956]

Moist Heat or Steam Sterilization

[08800048402956]

Moist Heat or Steam Sterilization

[08800048402956]

Moist Heat or Steam Sterilization

[08800048402956]

Moist Heat or Steam Sterilization

[08800048402956]

Moist Heat or Steam Sterilization

[08800048402956]

Moist Heat or Steam Sterilization

[08800048402956]

Moist Heat or Steam Sterilization

[08800048402956]

Moist Heat or Steam Sterilization

[08800048402956]

Moist Heat or Steam Sterilization

[08800048402956]

Moist Heat or Steam Sterilization

[08800048402956]

Moist Heat or Steam Sterilization

[08800048402956]

Moist Heat or Steam Sterilization

[08800048402956]

Moist Heat or Steam Sterilization

[08800048402956]

Moist Heat or Steam Sterilization

[08800048402956]

Moist Heat or Steam Sterilization

[08800048402956]

Moist Heat or Steam Sterilization

[08800048402956]

Moist Heat or Steam Sterilization

[08800048402956]

Moist Heat or Steam Sterilization

[08800048402956]

Moist Heat or Steam Sterilization

[08800048402956]

Moist Heat or Steam Sterilization

[08800048402956]

Moist Heat or Steam Sterilization

[08800048402956]

Moist Heat or Steam Sterilization

[08800048402956]

Moist Heat or Steam Sterilization

[08800048402956]

Moist Heat or Steam Sterilization

[08800048402956]

Moist Heat or Steam Sterilization

[08800048402956]

Moist Heat or Steam Sterilization

[08800048402956]

Moist Heat or Steam Sterilization

[08800048402956]

Moist Heat or Steam Sterilization

[08800048402956]

Moist Heat or Steam Sterilization

[08800048402956]

Moist Heat or Steam Sterilization

[08800048402956]

Moist Heat or Steam Sterilization

[08800048402956]

Moist Heat or Steam Sterilization

[08800048402956]

Moist Heat or Steam Sterilization

[08800048402956]

Moist Heat or Steam Sterilization

[08800048402956]

Moist Heat or Steam Sterilization

[08800048402956]

Moist Heat or Steam Sterilization

[08800048402956]

Moist Heat or Steam Sterilization

[08800048402956]

Moist Heat or Steam Sterilization

[08800048402956]

Moist Heat or Steam Sterilization

[08800048402956]

Moist Heat or Steam Sterilization

[08800048402956]

Moist Heat or Steam Sterilization

[08800048402956]

Moist Heat or Steam Sterilization

[08800048402956]

Moist Heat or Steam Sterilization

[08800048402956]

Moist Heat or Steam Sterilization

[08800048402956]

Moist Heat or Steam Sterilization

[08800048402956]

Moist Heat or Steam Sterilization

[08800048402956]

Moist Heat or Steam Sterilization

[08800048402956]

Moist Heat or Steam Sterilization

[08800048402956]

Moist Heat or Steam Sterilization

[08800048402956]

Moist Heat or Steam Sterilization

[08800048402956]

Moist Heat or Steam Sterilization

[08800048402956]

Moist Heat or Steam Sterilization

[08800048402956]

Moist Heat or Steam Sterilization

[08800048402956]

Moist Heat or Steam Sterilization

[08800048402956]

Moist Heat or Steam Sterilization

[08800048402956]

Moist Heat or Steam Sterilization

[08800048402956]

Moist Heat or Steam Sterilization

[08800048402956]

Moist Heat or Steam Sterilization

[08800048402956]

Moist Heat or Steam Sterilization

[08800048402956]

Moist Heat or Steam Sterilization

[08800048402956]

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.

08800311590199 - NA	2025-04-11 C7 TRIAL RASP Lordotic6° (W12xL14xH4)
08800311590205 - NA	2025-04-11 C7 TRIAL RASP Lordotic6° (W12xL14xH45)
08800311590212 - NA	2025-04-11 C7 TRIAL RASP Lordotic6° (W12xL14xH6)
08800311590229 - NA	2025-04-11 C7 TRIAL RASP Lordotic6° (W12xL14xH7)
08800311590236 - NA	2025-04-11 C7 TRIAL RASP Lordotic6° (W12xL14xH8)
08800311590243 - NA	2025-04-11 C7 TRIAL RASP Lordotic6° (W12xL14xH9)
08800311590250 - NA	2025-04-11 C7 TRIAL RASP Lordotic6° (W12xL14xH10)
08800311590267 - NA	2025-04-11 C7 TRIAL RASP Lordotic6° (W12xL14xH11)

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