AccessGUDID - DEVICE: Medyssey Poseidon OCT Spinal Fixation System (08800048403830)

GUDID

Device Identifier (DI) Information

Brand Name: Medyssey Poseidon OCT Spinal Fixation System
Version or Model: LRPPS3556
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Medyssey Co., Ltd.

Primary DI Number: 08800048403830
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 688211503 *Terms of Use

Device Description: Poseidon Reduction Smooth Shank Poly-Axial Screw, 3.5X56mm, 4.0mm rod

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
57806	Vertebral body prosthesis, non-sterile	A non-sterile implantable device designed to replace or repair (fuse) the spinal bony segments, or vertebrae, lost or injured as a consequence of, e.g., trauma, deformity, tumour, or degenerative disease. It is typically intended to be used with supplemental spinal fixation and may be used with a bone graft. It is usually made of metal, polymer, or a combination of these materials. This device must be sterilized prior to use.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
NKG	Orthosis, Cervical Pedicle Screw Spinal Fixation
KWP	Appliance, Fixation, Spinal Interlaminal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a16e660f-9950-44ab-b27c-2cb5ef553047
Public Version Date: April 12, 2019
Public Version Number: 1
DI Record Publish Date: April 04, 2019