Trinity Sterile, Inc.

Basic Information

• Brand Name: Trinity Sterile, Inc.
• Primary DI: 10649111492532
• Version / Model: 96-4137M
• Company Name: Trinity Sterile, Inc.
• Labeler DUNS: 154424043
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-12-16
• Public Version: 1
• Public Version Date: 2024-12-24
• Public Version Status: New
• Public Device Record Key: bcdca355-0604-40ed-ac71-d67119be5308

Device Description

ECONO STERILE OVAL BIOPSY FCP 3X7MM STER10

Device Characteristics

• Single Use: Yes
• 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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HFB	FORCEPS, BIOPSY, GYNECOLOGICAL	Obstetrics/Gynecology	884.4530	1

GMDN Terms

Code	Name	Definition	Implantable	Status
42500	Dressing/utility forceps, tweezers-like, reusable	A hand-held manual instrument designed primarily for non-dedicated grasping of devices, sponges and/or dressings during a procedure; it is neither intended for tissue manipulation nor endoscopic use. It typically has a tweezers-like design with two blades joined at the proximal (non-working) end with variously designed tips at the working end. It is made of metal and/or plastic materials and is available in various sizes. This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50649111492530	GS1		10	In Commercial Distribution
Primary	10649111492532	GS1