NA

Basic Information

• Brand Name: NA
• Primary DI: 10603295174271
• Version / Model: 5450-32-500
• Catalog Number: 545032500
• Company Name: DEPUY (IRELAND)
• Labeler DUNS: 989365556
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-24
• Public Version: 5
• Public Version Date: 2020-06-19
• Public Version Status: Update
• Public Device Record Key: 7ca96176-790f-4e45-97b9-46aa13fb4e64

Device Description

DEPUY CMW 2 GENTAMICIN Fast Set Bone Cement 20g

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LOD	BONE CEMENT	Orthopedic	888.3027	2
MBB	BONE CEMENT, ANTIBIOTIC	Orthopedic	888.3027	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46059	Orthopaedic cement, antimicrobial	A 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.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20603295174278	GS1	PACKAGE	10	In Commercial Distribution
Primary	10603295174271	GS1
Package	30603295174275	GS1	CASE	20	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K033382	000
K033563	000
K053002	000
K061144	000
K081163	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: High: 25 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: High: 25 Degrees Celsius