AccessGUDID - DEVICE: Sacroiliac Joint Fusion System (M719GSI2311150)

GUDID

Device Identifier (DI) Information

Brand Name: Sacroiliac Joint Fusion System
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: GSI231-115
Company Name: Genesys Orthopedics Systems LLC

Primary DI Number: M719GSI2311150
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 017921066 *Terms of Use

Device Description: 11.5mm Large-Bore SI Drill

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?
32390	Fluted surgical drill bit, reusable	A shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is usually inserted into a surgical power tool or a surgical hand drill/brace. This is a reusable 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
Outer Diameter: 11.5 Millimeter

Device Record Status

Public Device Record Key: 18fedf8d-2dad-4a37-ade4-115fe2a994df
Public Version Date: October 08, 2020
Public Version Number: 1
DI Record Publish Date: September 30, 2020