Brasseler USA

Basic Information

• Brand Name: Brasseler USA
• Primary DI: 00887919681007
• Version / Model: 5023303U0
• Company Name: Peter Brasseler Holdings, LLC
• Labeler DUNS: 082080136
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-08
• Public Version: 2
• Public Version Date: 2023-08-10
• Public Version Status: Update
• Public Device Record Key: ea2f1ba7-db93-4124-8246-a1e494ee5239

Device Description

CP113NS6 GCP NS #6 HDL 1P

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: Yes
• 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: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EMD	HEMOSTAT, SURGICAL	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
15047	Gauze packer	A hand-held, surgical instrument used for introducing and packing gauze or dressings into body cavities. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00887919681007	GS1