DEVICE: Benesta Hysteroscope Set (00857492008041)
Device Identifier (DI) Information
Benesta Hysteroscope Set
CAL-TR111
In Commercial Distribution
Caldera Medical, Inc.
CAL-TR111
In Commercial Distribution
Caldera Medical, Inc.
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
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
No | |
Yes | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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36628 | Rigid optical hysteroscope |
An endoscope with a rigid inserted portion intended for the visual examination and treatment of the canal of the cervix and the uterine cavity (uterus). It is inserted through the vagina during hysteroscopy. Anatomical images are transmitted to the user through relayed lens optics or a fibreoptic bundle. Distention of the uterus with, e.g., carbon dioxide(CO2) gas may be used to improve viewing. This device is typically used to evaluate/treat fibroids (myomas), polyps, or causes of severe cramping (dysmenorrhea), heavy menstrual periods (menorrhagia), and bleeding between periods (metrorrhagia). This is a reusable device.
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FDA Product Code
[?]Product Code | Product Code Name |
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HIH | Hysteroscope (And Accessories) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K192822 | 000 |
Sterilization
No
Yes
CLOSE
Yes
Sterilization Method [?] |
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Moist Heat or Steam Sterilization |
High-level Disinfectant |
Liquid Chemical |
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Store at room temperature, in clean and dry location |
Clinically Relevant Size
[?]Size Type Text |
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Outer Diameter: 5.8 Millimeter |
Device Record Status
6cf0cdbe-317a-44f7-9183-87c4489e40cb
November 17, 2023
2
August 03, 2022
November 17, 2023
2
August 03, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-818-879-6555
hello@calderamedical.com
hello@calderamedical.com