Precept®

Basic Information

• Brand Name: Precept®
• Primary DI: 20814707021077
• Version / Model: 8571
• Company Name: PRECEPT MEDICAL PRODUCTS, INC.
• Labeler DUNS: 783912892
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2018-09-18
• Public Version: 1
• Public Version Date: 2018-10-19
• Public Version Status: New
• Public Device Record Key: ac2d9b99-d706-4cf5-be65-2b92195230d1

Device Description

Cysto Apron

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: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	878.4040	1

GMDN Terms

Code	Name	Definition	Implantable	Status
40511	Hygiene apron, single-use	A non-sterile garment designed to be worn by healthcare staff for general protection from soiling or spills on the ventral (front) aspect of the body, and typically to prevent penetration of infectious material, during the course of work or a procedure. It is typically made of a thin plastic polymer. This is a single-use garment.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	20814707021077	GS1
Unit of Use	00814707021073	GS1

Customer Contacts

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