Aptimax

Basic Information

• Brand Name: Aptimax
• Primary DI: 10705037064489
• Version / Model: 15910
• Catalog Number: 15910
• 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: 2019-07-31
• Public Version: 7
• Public Version Date: 2023-06-22
• Public Version Status: Update
• Public Device Record Key: 82918d53-e7b3-4049-abd5-9c20d1488ea2

Device Description

Instrument Tray 278 mm x 270 mm x 100 mm (11 in x 10-5/8 in x 4 in)

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: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FRG	Wrap, sterilization	General Hospital	880.6850	2

GMDN Terms

Code	Name	Definition	Implantable	Status
12143	Instrument tray, reusable	A container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20705037064486	GS1	Case	2	In Commercial Distribution
Primary	10705037064489	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K013003	000