AccessGUDID - DEVICE: MIS FUSION Instruments (00846468000394)

GUDID

Device Identifier (DI) Information

Brand Name: MIS FUSION Instruments
Version or Model: 724-994
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 724-994
Company Name: Pioneer Surgical Technology, Inc.

Primary DI Number: 00846468000394
Issuing Agency: GS1
Commercial Distribution End Date: July 21, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 793384496 *Terms of Use

Device Description: MIS FUS, 7mm PADDLE DISTRACTOR, 3.3" OAL

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
LXH	ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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
Device Size Text, specify: 7mm (Width)

Device Record Status

Public Device Record Key: 08372a48-4e92-4f17-8f0b-ec79a48f6074
Public Version Date: November 08, 2024
Public Version Number: 3
DI Record Publish Date: June 15, 2019