Exact Medical Manufacturing

Basic Information

• Brand Name: Exact Medical Manufacturing
• Primary DI: 00850033380835
• Version / Model: E6451
• Catalog Number: E6451
• Company Name: EXACT MEDICAL MANUFACTURING, INC.
• Labeler DUNS: 014464314
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-12-07
• Public Version: 1
• Public Version Date: 2021-12-15
• Public Version Status: New
• Public Device Record Key: 286072f7-0ee4-4185-9f7d-b297bb26c793

Device Description

Probe Cover, VIP film, Gel, Elastic bands 15x91cm - 6"x36"

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: Yes
• 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	892.1570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44713	Body-surface ultrasound imaging transducer cover	A device/material intended to be used as a physical barrier for protection against the effects of environmental exposure (e.g., body fluids, gels) and/or to maintain the required hygienic level of an ultrasound system imaging transducer (probe) used on the body surface during an ultrasound examination. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00850033380842	GS1	Inner Case	20	In Commercial Distribution
Primary	00850033380835	GS1
Package	00850033380859	GS1	Case	3	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K211969	000