AccessGUDID - DEVICE: SI-RESTORE (00850073363171)

GUDID

Device Identifier (DI) Information

Brand Name: SI-RESTORE
Version or Model: 1701-300007
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BIOFUSION MANAGEMENT AND MANUFACTURING, LLC

Primary DI Number: 00850073363171
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 125905168 *Terms of Use

Device Description: DILATOR #2

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):	No
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?
65789	Endoscopic soft-tissue release system dilator/gauge	A patient-contact dilating/measuring component of an endoscopic soft-tissue release system intended to be used for minimally-invasive transection of soft connective tissue (e.g., fascia, tendon) under direct vision. It consists of a probe-like device that is connected to a dedicated handpiece (not included) and used to create a channel for the system’s cutting components and/or provide depth measurements for the transection. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GAD	Retractor

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K182919	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: 6066a0ed-e388-4ba4-aaf3-db4d2689da40
Public Version Date: March 25, 2025
Public Version Number: 1
DI Record Publish Date: March 17, 2025