Exact Medical Manufacturing, Inc.

Basic Information

• Brand Name: Exact Medical Manufacturing, Inc.
• Primary DI: 00817602020592
• Version / Model: 19140
• Catalog Number: 19140
• Company Name: EXACT MEDICAL MANUFACTURING, INC.
• Labeler DUNS: 014464314
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-27
• Public Version: 6
• Public Version Date: 2024-09-25
• Public Version Status: Update
• Public Device Record Key: dc637720-322d-4316-b9e1-da970ffdd83b
• Distribution End Date: 2024-09-24

Device Description

Split Sheet (60"x84")-

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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
KKX	Drape, Surgical	General, Plastic Surgery	878.4370	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47783	Patient surgical drape, single-use	A noninvasive sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to function as a barrier to cross contamination (e.g., isolate a site of surgical incision, protect non-operative anatomy). It is not designed with specific heat-reflective or laser resistant materials. It is available in a variety of designs (e.g., flat sheet with or without an access hole, leg tube or an adhesive film sheet otherwise known as an incise drape). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00817602020608	GS1	Case	52	Not in Commercial Distribution	2024-09-24
Primary	00817602020592	GS1

Customer Contacts

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