Benesta Hysteroscope Adapter

Basic Information

• Brand Name: Benesta Hysteroscope Adapter
• Primary DI: 00857492008164
• Version / Model: CAL-TR1431
• Company Name: Caldera Medical, Inc.
• Labeler DUNS: 130341956
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-07-19
• Public Version: 1
• Public Version Date: 2022-07-27
• Public Version Status: New
• Public Device Record Key: f1b54db2-159d-457c-82a4-9c2beaa865ec

Device Description

The Benesta Hysteroscope Adapter is placed between non-Caldera Medical hysteroscopes and the Benesta Tissue Removal Device (TRD) to properly position the TRD while in use.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	884.1690	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66095	Endoscope working-channel depth spacer	A rigid luminal device designed to proximally extend the lumen of an endoscope working-channel to restrict the insertion depth of an instrument (i.e., spacer functions between the endoscope and the instrument) typically to prevent unintentional injury. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00857492008164	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store at room temperature in a clean, dry location