Transobturator Helical, Left Introducer CAL-HL32

GUDID 00857492008003

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.

Caldera Medical, Inc.

Transobturator needle, reusable

Primary Device ID	00857492008003
NIH Device Record Key	e1fa1225-f6a0-42aa-bc09-233de25ca8fa
Commercial Distribution Status	In Commercial Distribution
Brand Name	Transobturator Helical, Left Introducer
Version Model Number	CAL-HL32
Catalog Number	CAL-HL32
Company DUNS	130341956
Company Name	Caldera Medical, Inc.
Device Count	1
DM Exempt	true
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	1-818-879-6555
Email	hello@calderamedical.com
Phone	1-818-879-6555
Email	hello@calderamedical.com
Phone	1-818-879-6555
Email	hello@calderamedical.com
Phone	1-818-879-6555
Email	hello@calderamedical.com
Phone	1-818-879-6555
Email	hello@calderamedical.com
Phone	1-818-879-6555
Email	hello@calderamedical.com
Phone	1-818-879-6555
Email	hello@calderamedical.com
Phone	1-818-879-6555
Email	hello@calderamedical.com
Phone	1-818-879-6555
Email	hello@calderamedical.com
Phone	1-818-879-6555
Email	hello@calderamedical.com
Phone	1-818-879-6555
Email	hello@calderamedical.com

Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *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.
Special Storage Condition, Specify	Between 0 and 0 *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.
Special Storage Condition, Specify	Between 0 and 0 *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.
Special Storage Condition, Specify	Between 0 and 0 *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.
Special Storage Condition, Specify	Between 0 and 0 *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.
Special Storage Condition, Specify	Between 0 and 0 *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.
Special Storage Condition, Specify	Between 0 and 0 *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.
Special Storage Condition, Specify	Between 0 and 0 *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.
Special Storage Condition, Specify	Between 0 and 0 *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.
Special Storage Condition, Specify	Between 0 and 0 *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.
Special Storage Condition, Specify	Between 0 and 0 *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.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857492008003 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K172614

FDA Product Code

PWJ	Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence