Novatome

Basic Information

• Brand Name: Novatome
• Primary DI: 00866215000002
• Version / Model: SU101-50
• Company Name: SCHOLTEN SURGICAL INSTRUMENTS, INC.
• Labeler DUNS: 130178346
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-06
• Public Version: 5
• Public Version Date: 2020-01-29
• Public Version Status: Update
• Public Device Record Key: 09a198b6-2895-4e11-b899-89c2d63f8d7e

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DWZ	Device, Biopsy, Endomyocardial	Cardiovascular	870.4075	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46679	Endomyocardial biopsy forceps, single-use	A sterile grasping instrument designed to obtain tissue samples from the inner walls of the heart (endomyocardium) typically for histopathological examination. It is typically a flexible metal coil or plastic tube with a pair of scissors-like cups with cutting edges around their rims at the distal end which are operated by a handle attached at the proximal end. It is usually introduced percutaneously through the jugular vein or femoral artery (during catheterization). Acquired tissue samples are typically used for assessment of early rejection of a transplanted heart, cardiomyopathy and myocarditis diagnosis, or detection of antracycline cardiotoxicity. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00866215000002	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K072051	000