TroClose1200™

Basic Information

• Brand Name: TroClose1200™
• Primary DI: 07290017191010
• Version / Model: GSTC1200C
• Company Name: GORDIAN SURGICAL LTD
• Labeler DUNS: 600087854
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-12-07
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 6210de8a-97da-44a6-a3ca-dde36f7c2192

Device Description

Single Use Cannula with Integrated Port Closure System for use *only* with a TroClose1200™ Obturator (found in REF# GSTC1200)

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: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• 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
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	876.1500	2
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	878.4493	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62869	Laparoscopic access cannulation/wound closure set	A collection of sterile devices which includes a laparoscopic access cannula with a dedicated, implantable, bioabsorbable wound closure thread, intended to: 1) puncture the abdominal wall to create an access port for laparoscopic instruments during laparoscopy; and 2) approximate subcutaneous tissue after removal of the cannula. The access cannula is often provided with a shut-off valve, sealing devices, and may include a trocar blade. The thread is integrated within the cannula and consists of a suture with an attached tag (anchor); the tag is designed to be deployed deep to the wound and the suture ligated upon removal of the cannula. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	27290017191014	GS1	Shipping box	2	In Commercial Distribution
Package	17290017191017	GS1	Shelf box	6	In Commercial Distribution
Primary	07290017191010	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K171494	000

Device Sizes

Type	Value	Unit	Text
Length	115	Millimeter
Lumen/Inner Diameter	12	Millimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 30 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: – 50 Degrees Celsius