Precept®

Basic Information

• Brand Name: Precept®
• Primary DI: 20814707021022
• Version / Model: 35 60260L
• Company Name: PRECEPT MEDICAL PRODUCTS, INC.
• Labeler DUNS: 783912892
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2018-09-18
• Public Version: 2
• Public Version Date: 2021-12-22
• Public Version Status: Update
• Public Device Record Key: 3e690836-60ea-473f-85cc-d41eb9ef9f5a

Device Description

Full-face Pullover Cleanroom Hood with Ties

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
FYF	Cap, Surgical	General, Plastic Surgery	878.4040	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32297	Surgical cap, single-use	A head covering designed as a cap intended to be worn by surgical staff during an operation to protect both the patient and themselves from the transfer of microorganisms, body fluids, and particulate material; it may also be used as a hygienic head covering in other healthcare settings. It is usually made of reinforced paper or non-woven materials. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	20814707021022	GS1
Unit of Use	00814707021028	GS1

Customer Contacts

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