AccessGUDID - DEVICE: OrthoSolutions 'System26' Bone Screws (05055662918397)

GUDID

Device Identifier (DI) Information

Brand Name: OrthoSolutions 'System26' Bone Screws
Version or Model: OS900065B-NS
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OS900065B-NS
Company Name: ORTHO SOLUTIONS HOLDINGS LIMITED

Primary DI Number: 05055662918397
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 218648211 *Terms of Use

Device Description: K-WIRE GUIDE INSERT FOR 6.5MM 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:	No
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?
47815	Orthopaedic implant aiming/guiding block, reusable	A surgical, jig-like device designed as a preshaped block with a defined pattern of prefabricated holes used to guide other instruments [e.g., drill sleeves and guide wires (Kirschner wires)] and/or to align a corresponding implant (e.g., a fixation plate) during an orthopaedic procedure. It is typically made of metallic or synthetic materials and may have an attachment point for an implant. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
LXH	Orthopedic Manual Surgical Instrument

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K163489	000

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: 326b2cf4-47f2-4223-9a4b-d5051354b181
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: March 16, 2017