AccessGUDID - DEVICE: GoPLF! Posterior Lateral Fusion System (07640387660836)

GUDID

Device Identifier (DI) Information

Brand Name: GoPLF! Posterior Lateral Fusion System
Version or Model: 4010002
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GetSet Surgical SA

Primary DI Number: 07640387660836
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 480143831 *Terms of Use

Device Description: The GoPLF! Auxiliary instrument set is an optional instrument that can be used if there is a surgical need for rod reduction (system-specific instruments)

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?
61300	Internal spinal fixation procedure kit, single-use	A collection of various orthopaedic manual surgical instruments (e.g., screwdriver, trial rod, adaptor, mallet, guide tube, chisel, rasp, awl, burr, tap, drill) intended to be used to perform a bone-screw internal spinal fixation and/or spinal fusion cage implantation procedure (including stereotactic procedures); implanted devices are not included. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NKB	Thoracolumbosacral Pedicle Screw System

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: 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: 2df708ed-933d-4051-ab79-9e0b0ae8da6f
Public Version Date: November 13, 2024
Public Version Number: 2
DI Record Publish Date: December 12, 2023