Benesta Sterilization Tray

GUDID 00857492008133

The Caldera Medical Benesta Sterilization Tray is intended to enclose, protect, and organize the Caldera Medical Benesta Rod Lens Hysteroscope and accessories during sterilization and storage. Does not include accessory caddy.

Caldera Medical, Inc.

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Primary Device ID	00857492008133
NIH Device Record Key	7e13e9a0-a98a-4f17-ae16-8d603e40e496
Commercial Distribution Status	In Commercial Distribution
Brand Name	Benesta Sterilization Tray
Version Model Number	CAL-TR131
Company DUNS	130341956
Company Name	Caldera Medical, Inc.
Device Count	1
DM Exempt	false
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	true
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
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
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 at room temperature in a clean, dry location
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a clean, dry location
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a clean, dry location
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a clean, dry location
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a clean, dry location
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a clean, dry location
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a clean, dry location
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a clean, dry location
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a clean, dry location
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a clean, dry location
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a clean, dry location
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a clean, dry location
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a clean, dry location
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a clean, dry location
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a clean, dry location
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a clean, dry location
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a clean, dry location
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a clean, dry location
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a clean, dry location
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a clean, dry location
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a clean, dry location
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a clean, dry location
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a clean, dry location
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a clean, dry location
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a clean, dry location

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857492008133 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K193603

FDA Product Code

KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories