FDA.report

BioCORE

Primary DI
00813954024745
Brand
BioCORE
Company
COLLAGEN MATRIX, INC.
Model
214-0025-BK
Device description
Moldable Bioactive Graft, 21mm x 21mm
Published
2022-05-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
MQVFiller, Bone Void, Calcium Compound

Product Code Classifications

CodeDeviceSpecialtyClass
MQVFiller, Bone Void, Calcium CompoundOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00813954024745PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00813954024745008139540247458139540247450813954024745

GMDN Terms

TermDefinition
Bone matrix implant, animal-derived, bioabsorbableA sterile bioabsorbable device made primarily of animal-derived bone matrix (e.g., bovine) implanted into the body to provide osteoconductive bone-tissue scaffolds to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis). It is used to fill bone cavities, defects, and fractures, and contains pores that promote the ingrowth of endogenous bone for skeletal reconstruction or augmentation. It is typically provided as cancellous blocks, chips, or granules of varying sizes, or mouldable materials.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Regulatory Flags

DUNS number
176262442
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00813954028590bioMAINTAINOUSA1EUOUSA1EU2026-03-23
00813954028606bioMAINTAINOUSA2EUOUSA2EU2026-03-23
00813954028613bioMAINTAINOUSA3EUOUSA3EU2026-03-23
00813954028484XENOFY-PXFP-050050XFP-0500502026-03-12
00813954028491XENOFY-PXFP-050100XFP-0501002026-03-12
00813954028507XENOFY-PXFP-050200XFP-0502002026-03-12
00813954028514XENOFY-PXFP-050400XFP-0504002026-03-12
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10813954028443Tissue Specialists Resorbable Collagen TapeT5091000T50910002026-03-09
00813954028453Tissue Specialists Resorbable Collagen MembraneT5096000T50960002026-03-09
00813954028460Tissue Specialists Resorbable Collagen MembraneT5093000T50930002026-03-09
00813954028477Tissue Specialists Resorbable Collagen MembraneT5098000T50980002026-03-09
10813954028542bioSTRIPOUSTPSOUSTPS2026-03-09
10813954028559bioPLUGOUSPGSOUSPGS2026-03-09
10813954028566bioKOTEOUSKTSOUSKTS2026-03-09
10813954021840PlatFORM CM StripCM46420CM464202016-08-01
00813954027470RCM6509600050960002026-01-07
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00810131882037Synthetic Fiber Graft - 6ccSURGENTEC, LLCMQV2026-03-09
00810131882044Synthetic Fiber Graft - 12ccSURGENTEC, LLCMQV2026-03-09
00810131882136Synthetic Fiber Kit - 1ccSURGENTEC, LLCMQV2026-03-09
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