CROWN SURGICAL

Basic Information

• Brand Name: CROWN SURGICAL
• Primary DI: B924121880
• Version / Model: HEMOSTATS
• Catalog Number: 12-188
• Company Name: CROWN SURGICAL CORPORATION
• Labeler DUNS: 645681094
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2021-03-05
• Public Version: 2
• Public Version Date: 2023-06-02
• Public Version Status: Update
• Public Device Record Key: d0ca578f-73f4-404d-9919-68b896f2ec20

Device Description

KELLY Hemostatic Forceps, Straight, 5-1/2"

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: Yes
• 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: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HRQ	Hemostat	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62490	Dressing/utility forceps, scissors-like, single-use	A hand-held manual instrument designed primarily for non-dedicated grasping of devices, sponges and/or dressings during a procedure; it is not intended for endoscopic use. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	B924121882	HIBCC	CARDBOARD BOX	600	In Commercial Distribution
Primary	B924121880	HIBCC
Unit of Use	B924121881	HIBCC

Customer Contacts

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