N/A

Basic Information

• Brand Name: N/A
• Primary DI: 00885825017095
• Version / Model: N/A
• Catalog Number: CTS12
• Company Name: STRYKER SUSTAINABILITY SOLUTIONS, INC.
• Labeler DUNS: 020198912
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-12
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 9365382c-f6df-462c-8884-63fce499daf5
• Distribution End Date: 2016-10-12

Device Description

Cannula and Seal Z-Thread Sleeve

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: Yes
• 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: 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
NLM	LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61813	Laparoscopic access cannula, reprocessed	A sterile, 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. It is available in a variety of dimensions and/or designs. This is a previously used single-use device that has been processed for an additional single-use patient application.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30885825017096	GS1	pack	12	Not in Commercial Distribution	2016-10-12
Primary	00885825017095	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K063788	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Diameter: 11.0 Millimeter
Length	100.0	Millimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: High: 54 Degrees Celsius