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Uvision Hysteroscope

FDA UDI

Class II (US FDA UDI)

by Uvision360, Inc.

Identity

Trade Name
Uvision Hysteroscope FDA UDI
Generic Name
Endoscope sheath, single-use FDA UDI
Model / Reference
LUMDTx-A1 FDA UDI

Identifiers

Catalog Number
20010 FDA UDI
Primary DI / UDI-DI
00853277008015 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

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
High-level Disinfectant FDA UDI

Category: Endoscope sheath, single-use

Uvision Hysteroscope 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 f21ab7a4-c71a-4142-94d5-078d6b86b3d6 34 fields · synced Jun 6, 2026