AccessGUDID - DEVICE: Regento Regenerative Scaffold (00852108006510)

GUDID

Device Identifier (DI) Information

Brand Name: Regento Regenerative Scaffold
Version or Model: 02-100-03-VTX
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 202937-10
Company Name: CYTOPHIL, INC.

Primary DI Number: 00852108006510
Issuing Agency: GS1
Commercial Distribution End Date: July 31, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 024222105 *Terms of Use

Device Description: Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate intended to fill bony void or gaps of the extremities, posterolateral spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.

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:	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?
17751	Bone matrix implant, synthetic, non-antimicrobial	A bioabsorbable device made of synthetic material intended to be implanted into the body to provide osteoconductive bone-tissue scaffolds, and sometimes osteovascularization, to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis); it does not include an antimicrobial agent(s). It may be made of ceramics (e.g., tricalcium phosphate or hydroxyapatite), bioactive glasses/minerals/metals (e.g., strontium), or bioabsorbable polymers. It is used to fill cystic defects, repair fractures, and/or extend autogenous bone grafts and is typically provided as cancellous blocks, chips, or granules of varying sizes, or mouldable/fluid materials.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MQV	Filler, Bone Void, Calcium Compound

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 15 and 32 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 10.0 Milliliter

Device Record Status

Public Device Record Key: 35af10dc-8b71-44c9-8fa5-bd074bb75951
Public Version Date: August 01, 2022
Public Version Number: 4
DI Record Publish Date: October 30, 2019