IRIS

Basic Information

• Brand Name: IRIS
• Primary DI: 07613327174816
• Version / Model: 0220180518
• Catalog Number: 0220180518
• Company Name: STRYKER CORPORATION
• Labeler DUNS: 187502109
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 4
• Public Version Date: 2019-02-07
• Public Version Status: Update
• Public Device Record Key: 6444a0fd-a4dd-43dc-bb3c-25679bb7c6d2

Device Description

[Ureteral Kit: 2 - Ureteral Catheters, 6 Fr Outer Diameter, 70 cm Length, 2 - Emitting Fiber, 0.75 Outer Diameter, 370 cm Length, Do not use if package is damaged]

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: 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
FCW	Light source, fiberoptic, routine	Gastroenterology, Urology	876.1500	2
FCS	Light, catheter, fiberoptic, glass, ureteral	Gastroenterology, Urology	876.4020	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32035	Ureteral transilluminator, single-use	A flexible tube containing a fibreoptic bundle that emits light throughout its length, intended to be inserted into the ureter for (trans)illumination to facilitate visualization of the ureter. It is used to aid dissection during laparoscopic and/or open abdominal surgery; sometimes it is referred to as illuminating catheter. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	37613327174817	GS1	pack	5	In Commercial Distribution
Primary	07613327174816	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K151243	000