Benesta Hysteroscope Set

GUDID 00857492008041

Benesta Rod Lens Hysteroscope for viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and operative/surgical procedures. The Set contains: CAL-TR113 Benesta Hysteroscope CAL-TR112 Benesta Outflow Channel CAL-TR121 Benesta Hysteroscope Light Source Adapter (Storz/Olympus) CAL-TR122 Benesta Hysteroscope Light Source Adapter (Dyonics/Wolf) CAL-TR123 Benesta Stopcock Lever and Cap (2 each) CAL-TR124 Benesta Hysteroscope/Outflow Channel End Cap (2 each) CAL-TR125 Benesta Working Channel Brush, 3mm CAL-TR126 Benesta Inflow Channel Brush, 2mm

Caldera Medical, Inc.

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Primary Device ID	00857492008041
NIH Device Record Key	6cf0cdbe-317a-44f7-9183-87c4489e40cb
Commercial Distribution Status	In Commercial Distribution
Brand Name	Benesta Hysteroscope Set
Version Model Number	CAL-TR111
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
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

Device Dimensions

Outer Diameter	5.8 Millimeter
Outer Diameter	5.8 Millimeter
Outer Diameter	5.8 Millimeter
Outer Diameter	5.8 Millimeter
Outer Diameter	5.8 Millimeter
Outer Diameter	5.8 Millimeter
Outer Diameter	5.8 Millimeter
Outer Diameter	5.8 Millimeter
Outer Diameter	5.8 Millimeter
Outer Diameter	5.8 Millimeter
Outer Diameter	5.8 Millimeter
Outer Diameter	5.8 Millimeter
Outer Diameter	5.8 Millimeter
Outer Diameter	5.8 Millimeter
Outer Diameter	5.8 Millimeter
Outer Diameter	5.8 Millimeter
Outer Diameter	5.8 Millimeter
Outer Diameter	5.8 Millimeter
Outer Diameter	5.8 Millimeter
Outer Diameter	5.8 Millimeter
Outer Diameter	5.8 Millimeter
Outer Diameter	5.8 Millimeter
Outer Diameter	5.8 Millimeter
Outer Diameter	5.8 Millimeter
Outer Diameter	5.8 Millimeter
Outer Diameter	5.8 Millimeter
Outer Diameter	5.8 Millimeter
Outer Diameter	5.8 Millimeter

Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature, in clean and dry location
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature, in clean and dry location
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature, in clean and dry location
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature, in clean and dry location
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature, in clean and dry location
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature, in clean and dry location
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature, in clean and dry location
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature, in clean and dry location
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature, in clean and dry location
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature, in clean and dry location
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature, in clean and dry location
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature, in clean and dry location
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature, in clean and dry location
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature, in clean and dry location
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature, in clean and dry location
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature, in clean and dry location
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature, in clean and dry location
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature, in clean and dry location
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature, in clean and dry location
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature, in clean and dry location
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature, in clean and dry location
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature, in clean and dry location
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature, in clean and dry location
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature, in clean and dry location
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature, in clean and dry location
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature, in clean and dry location
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature, in clean and dry location
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature, in clean and dry location

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857492008041 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K192822

FDA Product Code

HIH	Hysteroscope (And Accessories)