Corning®

Basic Information

• Brand Name: Corning®
• Primary DI: H1084306591
• Version / Model: 430659
• Catalog Number: 430659
• Company Name: Corning Incorporated
• Labeler DUNS: 001307735
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2020-12-02
• Public Version: 3
• Public Version Date: 2022-03-23
• Public Version Status: Update
• Public Device Record Key: 6028209f-2457-4c9e-b6b5-6c3872975991

Device Description

Corning 2mL External Threaded Polypropylene Cryogenic Vial, Self-Standing with Round Bottom

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: 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
FMH	CONTAINER, SPECIMEN, STERILE	Pathology	864.3250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47775	General specimen container IVD, no additive/medium	An empty covered receptacle containing no additives or media intended to be used for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, tissue) derived from different body regions for in vitro diagnostic investigation. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	H1084306593	HIBCC	Box	10	In Commercial Distribution
Primary	H1084306591	HIBCC
Unit of Use	H1084306590	HIBCC

Customer Contacts

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