Primary Device ID | 08800311591868 |
NIH Device Record Key | 6d6d104b-2076-4ca2-9494-03bc48c5ffe0 |
Commercial Distribution Status | In Commercial Distribution |
Version Model Number | SATM-D55 |
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 Issuing Agency | Device ID |
---|---|
GS1 | 08800311591868 [Primary] |
LXH | Orthopedic Manual Surgical Instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[08800311591868]
Moist Heat or Steam Sterilization
[08800311591868]
Moist Heat or Steam Sterilization
[08800311591868]
Moist Heat or Steam Sterilization
[08800311591868]
Moist Heat or Steam Sterilization
[08800311591868]
Moist Heat or Steam Sterilization
[08800311591868]
Moist Heat or Steam Sterilization
[08800311591868]
Moist Heat or Steam Sterilization
[08800311591868]
Moist Heat or Steam Sterilization
[08800311591868]
Moist Heat or Steam Sterilization
[08800311591868]
Moist Heat or Steam Sterilization
[08800311591868]
Moist Heat or Steam Sterilization
[08800311591868]
Moist Heat or Steam Sterilization
[08800311591868]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-07-09 |
Device Publish Date | 2025-07-01 |
08800311592049 - Medyssey Navigation Instrument | 2025-07-16 ARTeMIS Navigation Tap Ø 4.5 |
08809974438176 - Medyssey Navigation Instrument | 2025-07-16 Iliad Navigation Tap Ø 5.5 |
08809974438183 - Medyssey Navigation Instrument | 2025-07-16 Iliad Navigation Tap Ø 6.5 |
08809974438190 - Medyssey Navigation Instrument | 2025-07-16 Iliad Navigation Tap Ø 7.5 |
08809974444382 - Medyssey Navigation Instrument | 2025-07-16 Iliad Navigation Screw driver |
08809974444412 - Medyssey Navigation Instrument | 2025-07-16 Iliad Navigation Tap Ø 4.5 |
08800311591851 - NA | 2025-07-09 Zenius MIS Awl Tap Modular (Dual, Ø4.5) |
08800311591868 - NA | 2025-07-09Zenius MIS Awl Tap Modular (Dual, Ø5.5) |
08800311591868 - NA | 2025-07-09 Zenius MIS Awl Tap Modular (Dual, Ø5.5) |