Bouffant Cap 21" White

Basic Information

• Brand Name: Bouffant Cap 21" White
• Primary DI: 00850037747221
• Version / Model: BHC30021WE
• Company Name: Safesource Direct, L.L.C.
• Labeler DUNS: 118070602
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2024-10-01
• Public Version: 1
• Public Version Date: 2024-10-09
• Public Version Status: New
• Public Device Record Key: 328cca18-16e4-45c4-89d2-75274da832fe

Device Description

White Bouffant Cap 21" outside diameter.

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
Package	10850037747228	GS1	Case	4	In Commercial Distribution
Primary	00850037747221	GS1
Unit of Use	20850037747225	GS1

Customer Contacts

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