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Reli

FDA UDI

Class II (US FDA UDI)

by Myco Medical Supplies Inc.

Identity

Trade Name
RELI FDA UDI
Generic Name
Imaging lesion localization marker, external, single-use FDA UDI
Device Name
MAMMOREP N® Breast localization needle, simple hook-wire 21G x 9cm FDA UDI
Model / Reference
R-MRN2109 FDA UDI
Description
MAMMOREP N® Breast localization needle, simple hook-wire 21G x 9cm FDA UDI

Identifiers

Catalog Number
R-MRN2109 FDA UDI
Primary DI / UDI-DI
00386120008585 FDA UDI
510(k) Number
K051506 FDA UDI
FDA Product Code
KNW FDA UDI
FCG FDA UDI
GMDN Term
Imaging lesion localization marker, external, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
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

Dimensions & Sizes

Size
Length — 9 Centimeter FDA UDI
Needle Gauge — 21 Gauge FDA UDI

Category: Imaging lesion localization marker, external, single-use

Reli by Myco Medical Supplies Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Imaging lesion localization marker, external, single-use.

Cleared under the same submission

K051506 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Myco Medical Supplies Inc.

Sources (1)

  • FDA UDI d9529a35-26b9-414f-b46d-419eb42b0266 36 fields · synced May 30, 2026