AccessGUDID - DEVICE: SI-RESTORE (00850073363614)

GUDID

Device Identifier (DI) Information

Brand Name: SI-RESTORE
Version or Model: 2001-111065
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BIOFUSION MANAGEMENT AND MANUFACTURING, LLC

Primary DI Number: 00850073363614
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 125905168 *Terms of Use

Device Description: SI-RESTORE SCREW, HA BLASTED, 11.0MM x 65MM

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
61485	Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated	An implantable device designed to be inserted across the sacroiliac joint to provide temporary stabilization and to encourage long-term joint fusion, typically to alleviate pain from the joint. It is made of uncoated metal [e.g., titanium (Ti)], and typically in the form of a cylinder which may be threaded and/or fenestrated. It is typically surgically implanted under fluoroscopic guidance and may include dedicated disposable implantation instruments.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
HWC	Screw, Fixation, Bone
OUR	Sacroiliac Joint Fixation

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: 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
Length: 65 Millimeter
Outer Diameter: 11.0 Millimeter

Device Record Status

Public Device Record Key: c77a2192-966e-4f2f-8462-084d29270e0d
Public Version Date: March 18, 2025
Public Version Number: 1
DI Record Publish Date: March 10, 2025