Transobturator Helical, Left Introducer

Basic Information

• Brand Name: Transobturator Helical, Left Introducer
• Primary DI: 00857492008003
• Version / Model: CAL-HL32
• Catalog Number: CAL-HL32
• Company Name: Caldera Medical, Inc.
• Labeler DUNS: 130341956
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-08-03
• Public Version: 1
• Public Version Date: 2022-08-11
• Public Version Status: New
• Public Device Record Key: e1fa1225-f6a0-42aa-bc09-233de25ca8fa

Device Description

Transobturator Helical, 3.2mm, Left Introducer is a surgical mesh instrument to be used in surgical procedures for the insertion and placement of Desara surgical mesh.

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: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
PWJ	Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence	Obstetrics/Gynecology	884.4910	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47442	Transobturator needle, reusable	A hand-held manual surgical instrument with a sharp pyramidal or conical point intended to be used to create a percutaneous puncture using the transobturator approach (i.e., insertion points overlie the obturator space and the obturator foramen membrane is penetrated), for the surgical positioning of a sling used in the treatment of stress urinary incontinence (SUI), which may be associated with a prolapse. The distal working end is typically made of a stainless steel rod that is markedly curved or helicoidal (right- or left-angled), with a pointed tip and an eye or notch to help position the sling. The device can be made of metal and/or polymer materials. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00857492008003	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K172614	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store wrapped instruments in a designated sterile supply area that protects sterile items and their packaging from damage. This area should be clean, dry and free of contaminants.