Skytron DoVera Positioning Handle

FDA UDI

Class II (US FDA UDI)

by Skytron, LLC

Identity

Trade Name: Skytron DoVera Positioning Handle FDA UDI
Generic Name: Medical equipment/instrument drape, reusable FDA UDI
Device Name: Skytron DoVera Positioning Handle (Camera Cover Handle) FDA UDI
Model / Reference: 1950288 FDA UDI
Description: Skytron DoVera Positioning Handle (Camera Cover Handle) FDA UDI

Identifiers

Primary DI / UDI-DI: 10841736114985 FDA UDI
FDA Product Code: FSY FDA UDI
GMDN Term: Medical equipment/instrument drape, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4580 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Medical equipment/instrument drape, reusable

Skytron DoVera Positioning Handle by Skytron, LLC — 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: Skytron, LLC

Sources (1)

FDA UDI 08eb939e-399e-4756-b382-a0dce295e040 35 fields · synced Jun 6, 2026