Benesta Single-Use Seals

FDA UDI

Class II (US FDA UDI)

by Caldera Medical, Inc.

Identity

Trade Name: Benesta Single-Use Seals FDA UDI
Generic Name: Endoscope working-channel seal FDA UDI
Device Name: Benesta Single-Use Seals for Benesta Rod Lens Hysteroscope FDA UDI
Model / Reference: CAL-1421 FDA UDI
Description: Benesta Single-Use Seals for Benesta Rod Lens Hysteroscope FDA UDI

Identifiers

Primary DI / UDI-DI: 00857492008126 FDA UDI
FDA Product Code: HIH FDA UDI
GMDN Term: Endoscope working-channel seal FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.1690 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Endoscope working-channel seal

Benesta Single-Use Seals by Caldera Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Caldera Medical, Inc.

Sources (1)

FDA UDI 3ea50e10-ef6c-4a84-a94f-a5c2325bbdf8 35 fields · synced Jun 1, 2026