AccessGUDID - DEVICE: NanoFuse Bioactive Matrix

GUDID

Device Identifier (DI) Information

Brand Name: NanoFuse Bioactive Matrix - 1.0 cc
Version or Model: NAN109-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: NAN109-01
Company Name: AMEND SURGICAL, INC.

Primary DI Number: 00858686006034
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080131031 *Terms of Use

Device Description: Synthetic bone void filler containing DBM for orthopedic applications, provided in a syringe dispenser

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):	Yes

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61884	Cadaveric-donor/synthetic mineral bone graft	A sterile implantable device consisting of demineralized bone matrix (DBM) processed from cadaveric human bone (allograft) and mixed with bioabsorbable synthetic minerals (e.g., calcium phosphate), intended to fill bony voids or gaps in the skeletal system (e.g., spine, pelvis, extremities) that have been surgically or traumatically created; it may also serve as a bone graft extender. It is designed to be resorbed/remodelled and replaced by host bone during the healing process. It is typically supplied as a kit which requires mixing to form a putty-like substance prior to implantation.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MBP	Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
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 0 and 37 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 1.0 Milliliter

Device Record Status

Public Device Record Key: 4f5b6650-f66c-4fce-99b9-61388efc19a8
Public Version Date: December 18, 2023
Public Version Number: 4
DI Record Publish Date: January 12, 2018