Centurion

Basic Information

• Brand Name: Centurion
• Primary DI: 10653160327110
• Version / Model: PE3610
• Company Name: CENTURION MEDICAL PRODUCTS CORPORATION
• Labeler DUNS: 017246562
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-06-07
• Public Version: 1
• Public Version Date: 2019-06-17
• Public Version Status: New
• Public Device Record Key: b154fe5e-a966-4ab1-9604-85ba544d23a7

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• 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
MLS	Labor and Delivery Kit	Obstetrics/Gynecology	884.4530	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34122	Pelvic examination kit	A collection of sterile devices designed to perform a pelvic examination. It contains all of the various instruments, specimen collection materials, and pharmaceuticals necessary for this procedure. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00653160327113	GS1	CASE	20	In Commercial Distribution
Primary	10653160327110	GS1

Customer Contacts

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