AccessGUDID - DEVICE: NanoBone® SBX Putty (14260418440468)

GUDID

Device Identifier (DI) Information

Brand Name: NanoBone® SBX Putty
Version or Model: 200046
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Biocomposites GmbH

Primary DI Number: 14260418440468
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 332760383 *Terms of Use

Device Description: Synthetic biodegradable bone graft substitute consisting of NanoBone® | granulate (non-sintered nanocrystalline hydroxyapatite in a porous silica gel matrix) embedded in an aqueous gel

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 40 and 90 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 10.0 Milliliter

Device Record Status

Public Device Record Key: 7a28c0fb-a594-401b-bee4-b59b2faf6670
Public Version Date: November 10, 2023
Public Version Number: 5
DI Record Publish Date: November 07, 2016