AccessGUDID - DEVICE: Sacroiliac Joint Fusion System (M719PM10200)

GUDID

Device Identifier (DI) Information

Brand Name: Sacroiliac Joint Fusion System
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PM1020
Company Name: Genesys Orthopedics Systems LLC

Primary DI Number: M719PM10200
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 017921066 *Terms of Use

Device Description: Posterior SI Allograft Kit, Single, 20mm

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?
66046	Bone graft syringe, reusable	A calibrated barrel (cylinder) with plunger intended to be used to aspirate bone graft materials (e.g., autologous blood or bone marrow with allograft, autograft, demineralized bone, or synthetic/composite bone matrix graft materials) and deliver them to a surgical site during an orthopaedic, oral, or maxillofacial surgical procedure. 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
No Device Sizes

Device Record Status

Public Device Record Key: 7a0ada06-538a-4567-a9b8-84914778e0c4
Public Version Date: July 28, 2023
Public Version Number: 1
DI Record Publish Date: July 20, 2023