FDA.reportPublic FDA data

MgNum

Primary DI
00889795110985
Brand
MgNum
Company
Paragon 28, Inc.
Model
P02-BVF-0010
Catalog number
P02-BVF-0010
Device description
MgNum, Bone Void Filler, 10cc
Published
2022-10-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
MQVFILLER, BONE VOID, CALCIUM COMPOUND

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQVFiller, Bone Void, Calcium CompoundOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889795110985PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889795110985008897951109858897951109850889795110985

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone void filling material, synthetic, bioabsorbable, non-antimicrobialA bioabsorbable, implantable device made of a synthetic material(s) intended to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis); it is not dedicated to dental applications and 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. Also referred to as a graft, matrix, or void filler, it typically provides an osteoconductive scaffold that promotes bone growth, and is used to fill cystic defects, repair fractures, and/or extend autogenous bone grafts. It may have adhesive properties.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
042961576
Device count
1
DM exempt
true
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889795110978MgNumP02-BVF-0005P02-BVF-00052022-10-14
00889795110992MgNumP02-BVF-0015P02-BVF-00152022-10-14
00889795155856APEX 3D Total Ankle Replacement SystemP11-754-GA01P11-754-GA012026-09-29
00889795155863APEX 3D Total Ankle Replacement SystemP11-854-GA01P11-854-GA012026-09-29
00889795155870APEX 3D Total Ankle Replacement SystemP11-751-TP12P11-751-TP122026-09-29
00889795155887APEX 3D Total Ankle Replacement SystemP11-751-TP34P11-751-TP342026-09-29
00889795155894APEX 3D Total Ankle Replacement SystemP11-751-TP56P11-751-TP562026-09-29
00889795135278Baby Gorilla®/Gorilla® Plating SystemP50-900-AFSL-1P50-900-AFSL-12026-09-24
00889795135285Baby Gorilla®/Gorilla® Plating SystemP50-900-AFSL-2P50-900-AFSL-22026-09-24
00889795135292Baby Gorilla®/Gorilla® Plating SystemP50-900-AFSL-3P50-900-AFSL-32026-09-24
00889795135308Baby Gorilla®/Gorilla® Plating SystemP50-900-AFSL-4P50-900-AFSL-42026-09-24
00889795135315Baby Gorilla®/Gorilla® Plating SystemP50-900-AFSL-5P50-900-AFSL-52026-09-24
00889795135322Baby Gorilla®/Gorilla® Plating SystemP50-900-AFSL-6P50-900-AFSL-62026-09-24
00889795135339Baby Gorilla®/Gorilla® Plating SystemP50-900-AFSL-7P50-900-AFSL-72026-09-24
00889795120199Paragon 28 Bone Wedge SystemAOCWO-16-5AOCWO-16-52023-06-26
00889795120632Paragon 28 Bone Wedge SystemAOLEW-22-12AOLEW-22-122023-04-04
00889795118523Paragon 28 Bone Wedge SystemAOCW-TRL-16-4.5AOCW-TRL-16-4.52022-10-14
00889795118530Paragon 28 Bone Wedge SystemAOCW-TRL-16-5.5AOCW-TRL-16-5.52022-10-14
00889795118547Paragon 28 Bone Wedge SystemAOCW-TRL-16-6.5AOCW-TRL-16-6.52022-10-14
00889795118554Paragon 28 Bone Wedge SystemAOCW-TRL-18-4.5AOCW-TRL-18-4.52022-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199284455788BonVie+ELUTE , INC.MQV2025-08-13
00643169964938GRAFTON™ DBMMEDTRONIC SOFAMOR DANEK, INC.MQV2024-12-05
00763000140502PROGENIX™ PUTTY and PROGENIX™ PLUSMEDTRONIC SOFAMOR DANEK, INC.MQV2021-03-12
00763000140519PROGENIX™ PUTTY and PROGENIX™ PLUSMEDTRONIC SOFAMOR DANEK, INC.MQV2021-03-12
00763000140526PROGENIX™ PUTTY and PROGENIX™ PLUSMEDTRONIC SOFAMOR DANEK, INC.MQV2021-03-12
00763000140533PROGENIX™ PUTTY and PROGENIX™ PLUSMEDTRONIC SOFAMOR DANEK, INC.MQV2021-03-12
00085412630731ALTAPOREApatech LtdMQV2020-11-05
00085412678146ALTAPOREApatech LtdMQV2020-11-05
00085412654362ALTAPOREApatech LtdMQV2019-12-11
00085412654379ALTAPOREApatech LtdMQV2019-12-11
00085412654386ALTAPOREApatech LtdMQV2019-12-11
00085412654393ALTAPOREApatech LtdMQV2019-12-11
00613994247612PROGENIX® PUTTY and PROGENIX® PLUSMEDTRONIC SOFAMOR DANEK, INC.MQV2019-03-29
00643169965089GRAFTON® DBMMEDTRONIC SOFAMOR DANEK, INC.MQV2019-02-07
00613994512758MASTERGRAFT® Mini GranulesMEDTRONIC SOFAMOR DANEK, INC.MQV2018-11-18
00613994512765MASTERGRAFT® Mini GranulesMEDTRONIC SOFAMOR DANEK, INC.MQV2018-11-18
00613994512772MASTERGRAFT® Mini GranulesMEDTRONIC SOFAMOR DANEK, INC.MQV2018-11-18
00613994512789MASTERGRAFT® Mini GranulesMEDTRONIC SOFAMOR DANEK, INC.MQV2018-11-18
00613994512796MASTERGRAFT® Mini GranulesMEDTRONIC SOFAMOR DANEK, INC.MQV2018-11-18
00613994512802MASTERGRAFT® Mini GranulesMEDTRONIC SOFAMOR DANEK, INC.MQV2018-11-18
00613994512819MASTERGRAFT® Mini GranulesMEDTRONIC SOFAMOR DANEK, INC.MQV2018-11-18
00613994512826MASTERGRAFT® Mini GranulesMEDTRONIC SOFAMOR DANEK, INC.MQV2018-11-18
00643169965065GRAFTON® DBMMEDTRONIC SOFAMOR DANEK, INC.MQV2018-01-26
00643169141858MAGNIFUSE® Bone GraftMEDTRONIC SOFAMOR DANEK, INC.MQV2017-07-23
00643169719361MASTERGRAFT® StripMEDTRONIC SOFAMOR DANEK, INC.MQV2016-09-09
00643169719378MASTERGRAFT® StripMEDTRONIC SOFAMOR DANEK, INC.MQV2016-09-09
00643169719385MASTERGRAFT® StripMEDTRONIC SOFAMOR DANEK, INC.MQV2016-09-09
00643169218093PLEXUR P®MEDTRONIC SOFAMOR DANEK, INC.MQV2016-04-02
00643169218116PLEXUR P®MEDTRONIC SOFAMOR DANEK, INC.MQV2016-04-02
00643169218130PLEXUR P®MEDTRONIC SOFAMOR DANEK, INC.MQV2016-04-02