Winged Guide Accessory CAL-WI

GUDID 00890594000278

The Winged Guide Accessory may be referred to as the winged guide or guide and is for use with the Caldera Medical Inside-Out introducers only.

CALDERA MEDICAL, INC.

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Primary Device ID00890594000278
NIH Device Record Key9d302e58-cfe6-4421-84f0-2e95051629f4
Commercial Distribution StatusIn Commercial Distribution
Brand NameWinged Guide Accessory
Version Model NumberCAL-WI
Catalog NumberCAL-WI
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 Usetrue
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

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry and free of contaminants supply area.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry and free of contaminants supply area.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry and free of contaminants supply area.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry and free of contaminants supply area.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry and free of contaminants supply area.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry and free of contaminants supply area.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry and free of contaminants supply area.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry and free of contaminants supply area.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry and free of contaminants supply area.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry and free of contaminants supply area.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry and free of contaminants supply area.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry and free of contaminants supply area.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry and free of contaminants supply area.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry and free of contaminants supply area.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry and free of contaminants supply area.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry and free of contaminants supply area.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry and free of contaminants supply area.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry and free of contaminants supply area.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry and free of contaminants supply area.

Device Identifiers

Device Issuing AgencyDevice ID
GS100890594000278 [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

[00890594000278]

Dry Heat Sterilization


[00890594000278]

Dry Heat Sterilization


[00890594000278]

Dry Heat Sterilization


[00890594000278]

Dry Heat Sterilization


[00890594000278]

Dry Heat Sterilization


[00890594000278]

Dry Heat Sterilization


[00890594000278]

Dry Heat Sterilization


[00890594000278]

Dry Heat Sterilization


[00890594000278]

Dry Heat Sterilization


[00890594000278]

Dry Heat Sterilization


[00890594000278]

Dry Heat Sterilization


[00890594000278]

Dry Heat Sterilization


[00890594000278]

Dry Heat Sterilization


[00890594000278]

Dry Heat Sterilization


[00890594000278]

Dry Heat Sterilization


[00890594000278]

Dry Heat Sterilization


[00890594000278]

Dry Heat Sterilization


[00890594000278]

Dry Heat Sterilization


[00890594000278]

Dry Heat Sterilization


Device Entry Metadata

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

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