FDA.reportPublic FDA data

Cobalt MV with Gentamicin

Primary DI
00880304476783
Brand
Cobalt MV with Gentamicin
Company
Biomet Orthopedics, LLC
Model
402439
Catalog number
402439
Published
2015-11-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LODBone Cement
MBBBone Cement, Antibiotic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LODBone CementOrthopedic2
MBBBone Cement, AntibioticOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00880304476783PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304476783008803044767838803044767830880304476783

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic cement, medicatedA substance designed to be used in arthroplastic and/or osteosynthetic procedures for the fixation of polymer or metallic prosthetic implants to the living bone and/or to fill voids in the case of bone pathologies, and to treat infected joint prostheses or osteomyelitis; it may also be used prophylactically in primary or uninfected revision total joint arthroplasty. It is typically made from methylmethacrylate, polymethylmethacrylate (PMMA), esters of methacrylic acid or copolymers containing polymethylmethacrylate and polystyrene, and contains an antimicrobial agent. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-348-9500customerservice@biomet.com

Regulatory Flags#

DUNS number
129278169
Device count
1
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887868549236MULTI-DIRECTIONAL SCREW1312273081312273082022-11-14
00887868549243MULTI-DIRECTIONAL SCREW1312273091312273092022-11-14
00887868549250MULTI-DIRECTIONAL SCREW1312273101312273102022-11-14
00887868549267MULTI-DIRECTIONAL SCREW1312273111312273112022-11-14
00887868549274MULTI-DIRECTIONAL SCREW1312273121312273122022-11-14
00887868549281MULTI-DIRECTIONAL SCREW1312273131312273132022-11-14
00887868549298MULTI-DIRECTIONAL SCREW1312273141312273142022-11-14
00887868549304MULTI-DIRECTIONAL SCREW1312273151312273152022-11-14
00887868549311MULTI-DIRECTIONAL SCREW1312273161312273162022-11-14
00887868549328MULTI-DIRECTIONAL SCREW1312273181312273182022-11-14
00887868549335MULTI-DIRECTIONAL SCREW1312273201312273202022-11-14
00887868549342MULTI-DIRECTIONAL SCREW1312273221312273222022-11-14
00887868549359MULTI-DIRECTIONAL SCREW1312273241312273242022-11-14
00887868549366MULTI-DIRECTIONAL SCREW1312273261312273262022-11-14
00887868549373MULTI-DIRECTIONAL SCREW1312273281312273282022-11-14
00887868549380MULTI-DIRECTIONAL SCREW1312273301312273302022-11-14
00887868544699SMOOTH PEG1312270081312270082022-09-07
00887868544705SMOOTH PEG1312270091312270092022-09-07
00887868544712SMOOTH PEG1312270101312270102022-09-07
00887868544729SMOOTH PEG1312270111312270112022-09-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00887868551611StageOne SelectBiomet Orthopedics, LLCMBB2026-03-17
00887868551628StageOne SelectBiomet Orthopedics, LLCMBB2026-03-17
00887868551635StageOne SelectBiomet Orthopedics, LLCMBB2026-03-17
00887868551659StageOne SelectBiomet Orthopedics, LLCMBB2026-03-17
00887868551666StageOne SelectBiomet Orthopedics, LLCMBB2026-03-17
00887868551673StageOne SelectBiomet Orthopedics, LLCMBB2026-03-17
00887868551680StageOne SelectBiomet Orthopedics, LLCMBB2026-03-17
08031497003955Interspace GV Hip Spacer 46TECRES SPAMBB2026-02-11
08031497003962Interspace GV Hip Spacer 54TECRES SPAMBB2026-02-11
08031497003979Interspace GV Hip Spacer 60TECRES SPAMBB2026-02-11
08031497003986Interspace GV Hip Spacer 46 XLTECRES SPAMBB2026-02-11
08031497003993Interspace GV Hip Spacer 54 XLTECRES SPAMBB2026-02-11
08031497004006Interspace GV Hip Spacer 60 XLTECRES SPAMBB2026-02-11
03760177044326Signature -x Cement TEKNIMEDMBB2026-01-23
03760177044333Signature -x Cement TEKNIMEDMBB2026-01-23
03760177044340Signature -x Cement TEKNIMEDMBB2026-01-23
03760177040090GENTAFIXTEKNIMEDMBB2025-09-02
03760177040137GENTAFIXTEKNIMEDMBB2025-09-02
03760177043176GENTAFIXTEKNIMEDMBB2025-09-02
07613327545258AutoPlex VertaPlexSTRYKER CORPORATIONLOD2024-11-21
08058964728722Arthrex Bone Cement HV w/GG21 SRLMBB2024-09-16
08058964728746Arthrex Bone Cement MV w/GG21 SRLMBB2024-09-16
08058964729019BRAVO MV+GG21 SRLMBB2024-09-16
08058964729026BRAVO HV+GG21 SRLMBB2024-09-16
04260056882623BonOs HV GentaOSARTIS GmbHLOD2024-04-03
03770007907752V-STRUT Vertebral ImplantHyprevention Inc.LOD2024-02-27
03770007907769V-STRUT Vertebral ImplantHyprevention Inc.LOD2024-02-27
03770007907776V-STRUT Vertebral ImplantHyprevention Inc.LOD2024-02-27
03770007907783V-STRUT Vertebral ImplantHyprevention Inc.LOD2024-02-27
03770007907790V-STRUT Vertebral ImplantHyprevention Inc.LOD2024-02-27