TSI

Basic Information

• Brand Name: TSI
• Primary DI: 00851797006757
• Version / Model: TK-1241
• Company Name: TEDAN SURGICAL INNOVATIONS, L.L.C.
• Labeler DUNS: 791619393
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-06-12
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: ca2d79a4-d7e4-4d4e-9281-f4d6c0dc1748

Device Description

CONCAVE SPATULA, 65 MM, 20 MM, SST

Device Characteristics

• Single Use: No
• 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: No
• 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
GZT	Retractor, Self-Retaining, For Neurosurgery	Neurology	882.4800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35343	Brain spatula	A hand-held manual surgical instrument designed to manipulate neural tissue or to remove a material from a neural surface or vessel during brain surgery. It is typically made of high-grade stainless steel and consists of a handle proximally and a broad flat blunt blade (no sharp edges) that can be slightly curved or have various angles at the distal tip, or it can be double-ended. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00851797006757	GS1

Premarket Submissions

Submission Number	Supplement Number
K161318	000