Precept®

Basic Information

• Brand Name: Precept®
• Primary DI: 20814707021084
• Version / Model: 35 2502
• Company Name: PRECEPT MEDICAL PRODUCTS, INC.
• Labeler DUNS: 783912892
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 200
• 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: 5c744a80-1f1d-4d28-b2ab-725ab2765c86

Device Description

Protective Sleeve

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
62670	Surgical sleeve cover, non-sterile	A non-sterile forearm covering made of non-woven synthetic fabric materials intended to be worn over a scrub suit by healthcare staff during a surgical procedure to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material between the patient and staff. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	20814707021084	GS1
Unit of Use	00814707021080	GS1

Customer Contacts

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