AccessGUDID - DEVICE: Sacroiliac Joint Fusion System (M719GSI2250)

GUDID

Device Identifier (DI) Information

Brand Name: Sacroiliac Joint Fusion System
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: GSI225
Company Name: Genesys Orthopedics Systems LLC

Primary DI Number: M719GSI2250
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 017921066 *Terms of Use

Device Description: SI Luer Lock Graft Delivery

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):	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?
58449	Platelet rich fibrin biochemical preparation/application kit, endoscopic	A collection of sterile devices designed to be used for the biochemical preparation and subsequent delivery of autologous platelet rich fibrin (PRF) to a site of intervention during an endoscopic surgical procedure (e.g., to achieve haemostasis, enhance tissue growth, repair wounds). It typically consists of a dedicated preparation unit (a cassette) with a collection of application devices including an endoscopic applicator, needle, and tubing. Patient blood is contained within the preparation unit which is placed in a production unit (processor) which controls the biochemical processes and centrifugation to produce the PRF. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OUR	Sacroiliac Joint Fixation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K191748	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: d0bbadae-14c3-4038-870e-28836eb5e199
Public Version Date: December 24, 2019
Public Version Number: 1
DI Record Publish Date: December 16, 2019