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LUMINELLE DTx 360 Rotatable Disposable Sheaths

FDA UDI

Class II (US FDA UDI)

by Uvision360, Inc.

Identity

Trade Name
LUMINELLE DTx 360 Rotatable Disposable Sheaths FDA UDI
Generic Name
Endoscope sheath, single-use FDA UDI
Model / Reference
LUMDTx-360 FDA UDI

Identifiers

Catalog Number
20020 FDA UDI
Primary DI / UDI-DI
00853277008008 FDA UDI
510(k) Number
K181909 FDA UDI
FDA Product Code
HIH FDA UDI
FAJ FDA UDI
GMDN Term
Endoscope sheath, single-use FDA UDI

Classification

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

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

No

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 DTx 360 Rotatable Disposable Sheaths by Uvision360, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endoscope sheath, single-use.

Cleared under the same submission

K181909 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Uvision360, Inc.

Sources (1)

  • FDA UDI 811a70f7-2252-4b0f-b46e-8cc2c3b81a9a 35 fields · synced Jun 8, 2026