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LUMINELLE Dx 360o Rotatable Disposable Sheath (Diagnostic)

FDA UDI

Class II (US FDA UDI)

by Uvision360, Inc.

Identity

Trade Name
LUMINELLE Dx 360o Rotatable Disposable Sheath (Diagnostic) FDA UDI
Generic Name
Endoscope sheath, single-use FDA UDI
Device Name
The LUMINELLE DTx Hysteroscopy System with the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic). FDA UDI
Model / Reference
LUMDx-360 FDA UDI
Description
The LUMINELLE DTx Hysteroscopy System with the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic). FDA UDI

Identifiers

Catalog Number
20070 FDA UDI
Primary DI / UDI-DI
00853277008060 FDA UDI
510(k) Number
K192278 FDA UDI
FDA Product Code
FAJ FDA UDI
HIH FDA UDI
GMDN Term
Endoscope sheath, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 FDA UDI
884.1690 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

Category: Endoscope sheath, single-use

LUMINELLE Dx 360o Rotatable Disposable Sheath (Diagnostic) by Uvision360, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endoscope sheath, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Uvision360, Inc.

Sources (1)

  • FDA UDI 0dc9e3e0-441f-4175-9dfa-a41f89cccfc9 36 fields · synced May 31, 2026