ATEC

Basic Information

• Brand Name: ATEC
• Primary DI: 15420045503182
• Version / Model: ATEC Canister
• Catalog Number: ATEC Canister
• Company Name: Hologic, Inc.
• Labeler DUNS: 018925968
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-08-25
• Public Version: 5
• Public Version Date: 2022-12-08
• Public Version Status: Update
• Public Device Record Key: 0051939a-cf24-4f7a-be27-8743fca669a0

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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: Yes
• 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: Yes
• Sterilization Methods: Radiation Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KNW	INSTRUMENT, BIOPSY	Gastroenterology, Urology	876.1075	2

GMDN Terms

Code	Name	Definition	Implantable	Status
57927	General tissue specimen container IVD, fixative/saline	A covered receptacle (single- or multiple-compartment) containing a tissue fixation or preservation solution [e.g., formalin, saline] intended to be used for the collection, and preservation and/or transport, of any type of tissue specimen (e.g., biopsy tissue) collected from any body part for in vitro diagnostic investigation. It does not contain patient-contact tissue specimen sampling/excision devices. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	15420045503182	GS1
Unit of Use	05420045503185	GS1

Premarket Submissions

Submission Number	Supplement Number
K042290	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: High: 15 Degrees Celsius