NA

Basic Information

• Brand Name: NA
• Primary DI: 00852073002890
• Version / Model: Steen HS Catheter, 7F
• Catalog Number: TMI1189
• Company Name: C R I
• Labeler DUNS: 130814890
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-30
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: f485b66b-4c62-4290-8705-eb6e056b3b0f

Device Description

Balloon catheter with an insertion sheath for hysterosalpingography and sonohysterography for use with saline or water-based contrast media

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
LKF	Cannula, Manipulator/Injector, Uterine	Obstetrics/Gynecology	884.4530	2

GMDN Terms

Code	Name	Definition	Implantable	Status
18746	Intrauterine imaging medium catheter	A flexible tube designed for the intrauterine injection of an opaque tracer medium, to facilitate radiography of the fallopian tubes/uterus (salpingography/ hysterosalpingography), and/or a saline solution, to enhance transvaginal ultrasonography (TVUS) [saline infused sonography (SIS)/ hysterosonography]. It is typically a duel lumen tube, with a non-latex inflatable cuff (balloon), pad or cap near the distal tip intended to seal the cervix, and may include devices dedicated to catheter function (e.g., stylet, syringe). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10852073002897	GS1	Box	10	In Commercial Distribution
Primary	00852073002890	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K032835	000

Device Sizes

Type	Value	Unit	Text
Length	28	Centimeter
Catheter Gauge	7	French

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep out of direct sunlight
• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry