Home GUDID M386562301001 OsteoSparx C Putty
Primary DI M386562301001
Brand OsteoSparx C Putty
Company ISOTIS ORTHOBIOLOGICS, INC.
Model 56230100
Catalog number 56230100
Device description OsteoSparx C Putty, 10cc - derived from selected donated human bone tissue that has been processed into particles. The particles are subsequently demi
Published 2015-09-24
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name MBP Filler, bone void, osteoinduction (w/o human growth factor)
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10889981055783 Primary GS1 0 M386562301001 Secondary HIBCC 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10889981055783 10889981055783
GMDN Terms# Term, Definition table Term Definition Bone matrix implant, human-derived An sterile implantable device made primarily of human demineralized bone matrix (DBM) (acid extraction of allogeneic bone resulting in loss of most of the mineralized component but retention of proteins) intended to fill bony voids or gaps caused by trauma or surgery, including use in the maxillofacial and/or mandibular bone. The device is bioabsorbable, osteoconductive, and has demonstrated at least potential osteoinductivity for the stimulation of new bone growth. The DBM may be combined with various carrier compounds (e.g., gelatin, hydrogel, starch) or other materials. It is available in the form of powder, crushed granules, putty, chips, or a gel that can be injected through a syringe.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 15 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 801089152 Device count 1 DM exempt false Premarket exempt false HCT/P true Kit false Combination product false Lot or batch true Serial number true Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00810076560007 BiomaX Xtant Medical Holdings, Inc. MBP 2021-11-02 00810076560380 BiomaX Xtant Medical Holdings, Inc. MBP 2021-11-02 00810076560649 BiomaX Xtant Medical Holdings, Inc. MBP 2021-11-02 00810076560656 BiomaX Xtant Medical Holdings, Inc. MBP 2021-11-02 00810076560663 BiomaX Xtant Medical Holdings, Inc. MBP 2021-11-02 00810076560670 BiomaX Xtant Medical Holdings, Inc. MBP 2021-11-02 00810076560687 BiomaX Xtant Medical Holdings, Inc. MBP 2021-11-02 00810076560694 BiomaX Xtant Medical Holdings, Inc. MBP 2021-11-02 08809204338580 TruForm+ Hans Biomed Corp. MBP 2017-07-18 08809204338597 TruForm+ Hans Biomed Corp. MBP 2017-07-18 08809204338603 TruForm+ Hans Biomed Corp. MBP 2017-07-18 08809204338610 TruForm+ Hans Biomed Corp. MBP 2017-07-18 08809204338627 TruForm+ Hans Biomed Corp. MBP 2017-07-18 08809204338634 TruForm+ Hans Biomed Corp. MBP 2017-07-18 08809204338641 TruForm+ Hans Biomed Corp. MBP 2017-07-18 08809204338658 TruForm+ Hans Biomed Corp. MBP 2017-07-18 08809204338665 TruForm+ Hans Biomed Corp. MBP 2017-07-18 08809204338672 TruForm+ Hans Biomed Corp. MBP 2017-07-18 08809204338689 TruForm Hans Biomed Corp. MBP 2017-07-18 08809204338696 TruForm Hans Biomed Corp. MBP 2017-07-18 08809204338702 TruForm Hans Biomed Corp. MBP 2017-07-18 08809204338719 TruForm Hans Biomed Corp. MBP 2017-07-18 08809204338726 TruForm Hans Biomed Corp. MBP 2017-07-18 08809204338733 TruForm Hans Biomed Corp. MBP 2017-07-18 08809204338740 TruForm Hans Biomed Corp. MBP 2017-07-18 08809204338757 TruForm Hans Biomed Corp. MBP 2017-07-18 08809204338764 TruForm Hans Biomed Corp. MBP 2017-07-18 08809204338771 TruForm Hans Biomed Corp. MBP 2017-07-18 08809204338498 Exponent Hans Biomed Corp. MBP 2017-03-09 10885862094827 Optecure Exactech, Inc. MBP 2016-09-19