FDA.report

CARDINAL HEALTH

Primary DI
50885380066519
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
CMT-40-1
Catalog number
CMT-40-1
Device description
Orthopaedic cement, non-medicated
Published
2015-07-06
Public version status
Update
Distribution status
Not 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
LODBONE CEMENT

Product Code Classifications

CodeDeviceSpecialtyClass
LODBone CementOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50885380066519PackageGS120Not in Commercial Distribution
10885380066511PrimaryGS10

GMDN Terms

TermDefinition
Orthopaedic cement, non-antimicrobialA substance designed to be used in arthroplastic and/or osteosynthetic procedures for the fixation of polymer or metallic implants to the living bone. It may also be intended for use as a filler in the case of bone pathologies (e.g., to stabilize and reinforce vertebral body structures in vertebroplasty and kyphoplasty). It is typically made from methylmethacrylate, polymethylmethacrylate (PMMA), esters of methacrylic acid or copolymers containing polymethylmethacrylate and polystyrene. This device does not contain an antimicrobial agent. After application, this device cannot be reused.

Storage And Handling

TypeLowHighCondition
Handling Environment Temperature17 Degrees Celsius25 Degrees Celsius
Storage Environment Humidity30 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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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