AccessGUDID - DEVICE: OsteoCrete® Bone Void Filler (B4474415000BSI2)

GUDID

Device Identifier (DI) Information

Brand Name: OsteoCrete® Bone Void Filler
Version or Model: 15cc
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 44-150-00-BSI
Company Name: BONE SOLUTIONS, INC.

Primary DI Number: B4474415000BSI2
Issuing Agency: HIBCC
Commercial Distribution End Date: February 18, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 003506272 *Terms of Use

Device Description: OsteoCrete® is an injectable, moldable, and biocompatible Bone Void Filler. OsteoCrete® Bone Void Filler Packet contains powder (Magnesium based compound) and a mixing solution (Buffered saline). It is a sterile, single use device, packaged with mixing and administration tools.

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:	Yes
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 59 and 89 Degrees Fahrenheit
Storage Environment Temperature: between 15 and 32 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 257f6aa6-e0dd-4560-b328-c5639e5a1d1c
Public Version Date: June 19, 2020
Public Version Number: 4
DI Record Publish Date: August 04, 2017