TissueStat

Basic Information

• Brand Name: TissueStat
• Primary DI: B532TIS0030
• Version / Model: TIS-003
• Catalog Number: TIS-003
• Company Name: DURASTAT LLC
• Labeler DUNS: 080315253
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-18
• Public Version: 2
• Public Version Date: 2023-09-28
• Public Version Status: Update
• Public Device Record Key: 0e0d9c8b-9c0a-4986-9d29-fa1a0fc2403a

Device Description

TissueStat (TIS-003) is a class I suture deployment device that allows healthcare professionals to place a needle through soft tissue and facilitates the placement of sutures and knot tying for tissue approximation and/or ligation.

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: 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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HXK	Holder, Needle; Orthopedic	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47568	Suturing needle holder, single-use	A hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It has short serrated jaws at the distal end to provide better grip of the needle, and is available in a wide variety of sizes and designs, such as: 1) a self-retaining, scissors-like design with ring handles at the proximal end; 2) a tweezers-like design with bowed, hinged handles that are operated by squeezing them together; and 3) a heavy-duty pincer-like design. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B532TIS0030	HIBCC

Customer Contacts

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