ELMED

Basic Information

• Brand Name: ELMED
• Primary DI: 00842180185357
• Version / Model: SPTB-175
• Catalog Number: SPTB-175
• Company Name: ELMED INCORPORATED
• Labeler DUNS: 049290364
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-02-20
• Public Version: 1
• Public Version Date: 2024-02-28
• Public Version Status: New
• Public Device Record Key: 7fcd4002-3d97-4259-be3a-921816ff4fb8

Device Description

PATTERSON TROCAR 7 1/2" (19.0CM) WORKING SHAFT LENGTH, TROCAR SHARP POINTS, CANNULA AND HANDLE ARE STAINLESS STEEL, SIZE 1, 6MM DIA. (TROCAR POINTS MUST BE VERY SHARP)

Device Characteristics

• Single Use: No
• 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: No
• 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
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	870.4500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37148	Laparoscopic access cannula, reusable	A single-lumen surgical device intended to be percutaneously inserted through the abdominal wall to create an access port for a laparoscope/laparoscopic instrument during laparoscopy. The cannula is often provided with a shut-off valve for gas/fluid supply, and other sealing devices (e.g., dedicated seals/rings, caps, valves), to prevent insufflation gas leakage whilst allowing entry of instruments. It may include a sharp or blunt trocar blade to assist introduction and/or puncture the abdominal wall; if the trocar is included it may be referred to as a trocar or trocar assembly. It is available in a variety of dimensions and/or designs. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00842180185357	GS1

Customer Contacts

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