AccessGUDID - DEVICE: VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM (18056099648608)

GUDID

Device Identifier (DI) Information

Brand Name: VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 000-K-012C
Company Name: ORTHOFIX SRL

Primary DI Number: 18056099648608
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 438793622 *Terms of Use

Device Description: RIVAL REDUCE KIT PLATES

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?
44759	General internal orthopaedic fixation system implantation kit	A collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HRS	Plate, Fixation, Bone

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K142135	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

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: dfc7bee0-05bc-4a82-aa2c-2a1e49bceb9b
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: June 07, 2017