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LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy)

FDA UDI

Class II (US FDA UDI)

by Uvision360, Inc.

Identity

Trade Name
LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy) FDA UDI
Generic Name
Endometrial biopsy curette FDA UDI
Device Name
LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy) FDA UDI
Model / Reference
LUMBx-360 DOWN FDA UDI
Description
LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy) FDA UDI

Identifiers

Catalog Number
20085 FDA UDI
Primary DI / UDI-DI
00853277008091 FDA UDI
510(k) Number
K210512 FDA UDI
FDA Product Code
HIH FDA UDI
FAJ FDA UDI
HFF FDA UDI
FCK FDA UDI
GMDN Term
Endometrial biopsy curette FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
884.1690 FDA UDI
876.1500 FDA UDI
884.1060 FDA UDI
876.1075 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: Endometrial biopsy curette

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

Similar devices

Also classified as Endometrial biopsy curette.

Cleared under the same submission

K210512 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 ef281179-81d9-479e-be7f-ee0468708ca0 36 fields · synced May 30, 2026