Transobturator Hook Introducer CAL-TB03

GUDID 00890594000216

Transobturator Hook Introducer is a surgical mesh instrument to be used in surgical procedures for the insertion and placement of Desara surgical mesh.

CALDERA MEDICAL, INC.

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Primary Device ID00890594000216
NIH Device Record Key741becfb-b6ef-4be5-9020-eb2780c83871
Commercial Distribution StatusIn Commercial Distribution
Brand NameTransobturator Hook Introducer
Version Model NumberCAL-TB03
Catalog NumberCAL-TB03
Company DUNS130341956
Company NameCALDERA MEDICAL, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-866-422-5337
Emailinfo@calderamedical.com
Phone1-866-422-5337
Emailinfo@calderamedical.com
Phone1-866-422-5337
Emailinfo@calderamedical.com
Phone1-866-422-5337
Emailinfo@calderamedical.com
Phone1-866-422-5337
Emailinfo@calderamedical.com
Phone1-866-422-5337
Emailinfo@calderamedical.com
Phone1-866-422-5337
Emailinfo@calderamedical.com
Phone1-866-422-5337
Emailinfo@calderamedical.com
Phone1-866-422-5337
Emailinfo@calderamedical.com
Phone1-866-422-5337
Emailinfo@calderamedical.com
Phone1-818-879-6555
Emailhello@calderamedical.com
Phone1-818-879-6555
Emailhello@calderamedical.com
Phone1-818-879-6555
Emailhello@calderamedical.com
Phone1-818-879-6555
Emailhello@calderamedical.com
Phone1-818-879-6555
Emailhello@calderamedical.com
Phone1-818-879-6555
Emailhello@calderamedical.com
Phone1-818-879-6555
Emailhello@calderamedical.com
Phone1-818-879-6555
Emailhello@calderamedical.com
Phone1-818-879-6555
Emailhello@calderamedical.com
Phone1-818-879-6555
Emailhello@calderamedical.com
Phone1-818-879-6555
Emailhello@calderamedical.com
Phone1-818-879-6555
Emailhello@calderamedical.com
Phone1-818-879-6555
Emailhello@calderamedical.com
Phone1-818-879-6555
Emailhello@calderamedical.com
Phone1-818-879-6555
Emailhello@calderamedical.com
Phone1-818-879-6555
Emailhello@calderamedical.com
Phone1-818-879-6555
Emailhello@calderamedical.com
Phone1-818-879-6555
Emailhello@calderamedical.com
Phone1-818-879-6555
Emailhello@calderamedical.com
Phone1-818-879-6555
Emailhello@calderamedical.com
Phone1-818-879-6555
Emailhello@calderamedical.com
Phone1-818-879-6555
Emailhello@calderamedical.com
Phone1-818-879-6555
Emailhello@calderamedical.com
Phone1-818-879-6555
Emailhello@calderamedical.com
Phone1-818-879-6555
Emailhello@calderamedical.com
Phone1-818-879-6555
Emailhello@calderamedical.com
Phone1-818-879-6555
Emailhello@calderamedical.com
Phone1-818-879-6555
Emailhello@calderamedical.com
Phone1-818-879-6555
Emailhello@calderamedical.com
Phone1-818-879-6555
Emailhello@calderamedical.com
Phone1-818-879-6555
Emailhello@calderamedical.com
Phone1-818-879-6555
Emailhello@calderamedical.com
Phone1-818-879-6555
Emailhello@calderamedical.com
Phone1-818-879-6555
Emailhello@calderamedical.com
Phone1-818-879-6555
Emailhello@calderamedical.com
Phone1-818-879-6555
Emailhello@calderamedical.com
Phone1-818-879-6555
Emailhello@calderamedical.com
Phone1-818-879-6555
Emailhello@calderamedical.com
Phone1-818-879-6555
Emailhello@calderamedical.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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 AgencyDevice ID
GS100890594000216 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PWJInstrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00890594000216]

Dry Heat Sterilization


[00890594000216]

Dry Heat Sterilization


[00890594000216]

Dry Heat Sterilization


[00890594000216]

Dry Heat Sterilization


[00890594000216]

Dry Heat Sterilization


[00890594000216]

Dry Heat Sterilization


[00890594000216]

Dry Heat Sterilization


[00890594000216]

Dry Heat Sterilization


[00890594000216]

Dry Heat Sterilization


[00890594000216]

Dry Heat Sterilization


[00890594000216]

Dry Heat Sterilization


[00890594000216]

Dry Heat Sterilization


[00890594000216]

Dry Heat Sterilization


[00890594000216]

Dry Heat Sterilization


[00890594000216]

Dry Heat Sterilization


[00890594000216]

Dry Heat Sterilization


[00890594000216]

Dry Heat Sterilization


[00890594000216]

Dry Heat Sterilization


[00890594000216]

Dry Heat Sterilization


[00890594000216]

Moist Heat or Steam Sterilization


[00890594000216]

Moist Heat or Steam Sterilization


[00890594000216]

Moist Heat or Steam Sterilization


[00890594000216]

Moist Heat or Steam Sterilization


[00890594000216]

Moist Heat or Steam Sterilization


[00890594000216]

Moist Heat or Steam Sterilization


[00890594000216]

Moist Heat or Steam Sterilization


[00890594000216]

Moist Heat or Steam Sterilization


[00890594000216]

Moist Heat or Steam Sterilization


[00890594000216]

Moist Heat or Steam Sterilization


[00890594000216]

Moist Heat or Steam Sterilization


[00890594000216]

Moist Heat or Steam Sterilization


[00890594000216]

Moist Heat or Steam Sterilization


[00890594000216]

Moist Heat or Steam Sterilization


[00890594000216]

Moist Heat or Steam Sterilization


[00890594000216]

Moist Heat or Steam Sterilization


[00890594000216]

Moist Heat or Steam Sterilization


[00890594000216]

Moist Heat or Steam Sterilization


[00890594000216]

Moist Heat or Steam Sterilization


[00890594000216]

Moist Heat or Steam Sterilization


[00890594000216]

Moist Heat or Steam Sterilization


[00890594000216]

Moist Heat or Steam Sterilization


[00890594000216]

Moist Heat or Steam Sterilization


[00890594000216]

Moist Heat or Steam Sterilization


[00890594000216]

Moist Heat or Steam Sterilization


[00890594000216]

Moist Heat or Steam Sterilization


[00890594000216]

Moist Heat or Steam Sterilization


[00890594000216]

Moist Heat or Steam Sterilization


[00890594000216]

Moist Heat or Steam Sterilization


[00890594000216]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-10-08
Device Publish Date2019-09-30

Devices Manufactured by CALDERA MEDICAL, INC.

00857492008003 - Transobturator Helical, Left Introducer2022-08-11 Transobturator Helical, 3.2mm, Left Introducer is a surgical mesh instrument to be used in surgical procedures for the insertion
00857492008010 - Transobturator Helical, Right Introducer2022-08-11 Transobturator Helical, 3.2mm, Right Introducer is a surgical mesh instrument to be used in surgical procedures for the insertio
00857492008041 - Benesta Hysteroscope Set2022-08-11 Benesta Rod Lens Hysteroscope for viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and
00857492008065 - Benesta Sterilization Tray 2022-08-11 The Caldera Medical Benesta Sterilization Tray is intended to enclose, protect, and organize the Caldera Medical Benesta Rod Len
00857492008133 - Benesta Sterilization Tray2022-08-11 The Caldera Medical Benesta Sterilization Tray is intended to enclose, protect, and organize the Caldera Medical Benesta Rod Len
00890594000070 - Desara Blue SL2022-08-11 Desara® Blue SL sling system for female stress urinary incontinence.
00890594000124 - Desara Blue TVez 3.02022-08-11 Desara Blue TVez 3.0mm for the treatment of female stress urinary incontinence (SUI) or mixed incontinence
00890594000131 - Desara TVez 2.72022-08-11 Desara TVez 2.7mm for the treatment of female stress urinary incontinence (SUI) or mixed incontinence

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