AccessGUDID - DEVICE: OIC Pedicle Screw System (M696PS5540010)

GUDID

Device Identifier (DI) Information

Brand Name: OIC Pedicle Screw System
Version or Model: PS5.5-4001
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: ORTHOPAEDIC IMPLANT COMPANY, THE

Primary DI Number: M696PS5540010
Issuing Agency: HIBCC
Commercial Distribution End Date: January 01, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 070061160 *Terms of Use

Device Description: PEDICLE SCREW, SET SCREW

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):	Yes
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?
63998	Implantable orthopaedic/craniofacial device connection screw	A small implantable surgical device designed to join (connect) two components of an implanted orthopaedic and/or craniofacial device (e.g. osteotomy wedge to plate, femoral neck screw and plate); it is not intended to be screwed into the bone. It is typically made of metal and in the form of a short rod with machine threads at one end and a connecting slot (e.g., sunken Hex head) or thumbscrew at the other end.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MNI	Orthosis, Spinal Pedicle Fixation

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
Outer Diameter: 5.5 Millimeter

Device Record Status

Public Device Record Key: f4b1ffa6-eb11-4b46-9e13-99f43fe81227
Public Version Date: June 09, 2025
Public Version Number: 6
DI Record Publish Date: February 09, 2017