Benesta Single-Use Seals

Basic Information

• Brand Name: Benesta Single-Use Seals
• Primary DI: 00857492008126
• Version / Model: CAL-1421
• Company Name: Caldera Medical, Inc.
• Labeler DUNS: 130341956
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-07-18
• Public Version: 1
• Public Version Date: 2022-07-26
• Public Version Status: New
• Public Device Record Key: 3ea50e10-ef6c-4a84-a94f-a5c2325bbdf8

Device Description

Benesta Single-Use Seals for Benesta Rod Lens Hysteroscope

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
60650	Endoscope working-channel seal	A sterile device intended to be fitted over the working channel access port of an endoscope to minimize leakage of liquids and gases through the working channel, while permitting entry of endoscopic devices. It is typically a small plastic Luer attachment with an intraluminal seal. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00857492008072	GS1	Box	10	In Commercial Distribution
Primary	00857492008126	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