TSI

Basic Information

• Brand Name: TSI
• Primary DI: 00843059112368
• Version / Model: ML-0053
• 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: 2017-08-22
• Public Version: 3
• Public Version Date: 2023-09-15
• Public Version Status: Update
• Public Device Record Key: 586a6085-5dcc-4186-9e75-9141fe614597
• Distribution End Date: 2023-09-14

Device Description

ACMI ADAPTER

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: Yes
• 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
FDG	Retractor, Fiberoptic	Gastroenterology, Urology	876.4530	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37089	Light source adaptor	A small connecting device designed to permit the connection of the devices that together deliver light to a work field from a light source. This device is used to connect together products of dissimilar manufacture and dimensions, e.g., a fibreoptic light cable of one manufacture to the light source of another. It may also be used at the instrument end. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00843059112368	GS1