AMG

Basic Information

• Brand Name: AMG
• Primary DI: 00850017650305
• Version / Model: BCPB001XL
• Company Name: ARROW MEDSOURCE GROUP LIMITED
• Labeler DUNS: 686378503
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2020-06-22
• Public Version: 2
• Public Version Date: 2021-12-22
• Public Version Status: Update
• Public Device Record Key: fcfdb37d-6fe0-480e-a092-010a837c8b0a

Device Description

BOUFFANT CAPS, PREMIUM, XL

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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	10850017650302	GS1	Case	10	In Commercial Distribution
Primary	00850017650305	GS1
Unit of Use	00850017650459	GS1