FDA.report

Cobalt HV with Gentamicin

Primary DI
00880304560796
Brand
Cobalt HV with Gentamicin
Company
Biomet Orthopedics, LLC
Model
402283
Catalog number
402283
Published
2015-11-28
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

Related Records

Contact Domains

Product Codes

CodeName
LODBone Cement

Product Code Classifications

CodeDeviceSpecialtyClass
LODBone CementOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00880304560796PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304560796008803045607968803045607960880304560796

GMDN Terms

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

Contacts

PhoneEmail
1-800-348-9500customerservice@biomet.com

Regulatory Flags

DUNS number
129278169
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
true
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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