TSI

Basic Information

• Brand Name: TSI
• Primary DI: 00843059116366
• Version / Model: TK-0408S
• Company Name: TEDAN SURGICAL INNOVATIONS, L.L.C.
• Labeler DUNS: 791619393
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-11-10
• Public Version: 3
• Public Version Date: 2023-06-15
• Public Version Status: Update
• Public Device Record Key: 3b20774c-3f17-4846-86c1-be84463efb46
• Distribution End Date: 2023-06-14

Device Description

BLUNT SCALP HOOK, LARGE

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: 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
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64022	Soft-tissue surgical hook, single-use	A hand-held, shaft-like, manual surgical instrument designed for hooking and applying traction to specific soft-tissues of interest (e.g., skin, vessel, organ, and/or duct), to facilitate surgical intervention; it is not dedicated to separating or drawing aside the margins of a surgical wound/incision (i.e., not a blade-style retractor). The device includes a handle and tapers towards the distal end to form a slender hook/parallel hooks. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10843059116363	GS1		5	Not in Commercial Distribution	2023-06-14
Primary	00843059116366	GS1