FDA UDI In Commercial Distribution 🇺🇸 United States

Medyssey Spinal System - Deformity

DI: 08806364641208 · Model: RAH505 · Medyssey Co., Ltd.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Medyssey Spinal System - Deformity
Primary DI
08806364641208
Version / Model
RAH505
Company Name
Medyssey Co., Ltd.
Labeler DUNS
688211503
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-08-18
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
4a1f458a-1c16-4cb6-ae90-0a131a8170ef

Device Description

Right Angle Hook, Throat Depth 11mm, Hook Width 9mm, Hook Angle 30°, Ø6.0mm Rod

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
Yes
Sterilization Methods
Moist Heat or Steam Sterilization

Product Codes

Code Name
MNI Orthosis, Spinal Pedicle Fixation
MNH Orthosis, Spondylolisthesis Spinal Fixation
KWP Appliance, Fixation, Spinal Interlaminal

GMDN Terms

Code Name
61325 Bone-screw internal spinal fixation system, non-sterile

Identifiers

Type ID
Primary 08806364641208