Sterrad

Basic Information

• Brand Name: Sterrad
• Primary DI: 10705037014583
• Version / Model: 10113
• Catalog Number: 10113
• Company Name: ADVANCED STERILIZATION PRODUCTS SERVICES INC.
• Labeler DUNS: 947451626
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 5
• Public Version Date: 2023-06-22
• Public Version Status: Update
• Public Device Record Key: 591f3b2c-f7dc-4ef8-a122-7b4e226f7d9f

Device Description

Sterrad 100s Cassette

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MLR	Sterilizer, chemical	General Hospital	880.6860	2
FLF	Sterilizer, ethylene-oxide gas	General Hospital	880.6860	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44835	Hydrogen peroxide device sterilant	A gaseous or liquid substance that includes hydrogen peroxide (H2O2) as its primary agent to completely destroy or eliminate all harmful microorganisms on a medical device (e.g., surgical or dental instrument). The medical device is typically bathed by the substance for a specified period of time in order to achieve sterilization. The substance may be presented in discrete quantities to accommodate the requirements of a sterilization device or system. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20705037014580	GS1	Case	5	In Commercial Distribution
Primary	10705037014583	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K023290	000
K991999	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius