Reli

FDA UDI

Class II (US FDA UDI)

by Myco Medical Supplies Inc.

Identity

Trade Name: RELI FDA UDI
Generic Name: Needle guide, single-use FDA UDI
Device Name: AGO GUIDA® Guide Needle for COLT, 13G x 2.85" FDA UDI
Model / Reference: R-AGC1411 FDA UDI
Description: AGO GUIDA® Guide Needle for COLT, 13G x 2.85" FDA UDI

Identifiers

Catalog Number: R-AGC1411 FDA UDI
Primary DI / UDI-DI: 00386120008066 FDA UDI
510(k) Number: K051506 FDA UDI
FDA Product Code: KNW FDA UDI
FCG FDA UDI
GMDN Term: Needle guide, 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

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Length — 72.5 Centimeter FDA UDI
Needle Gauge — 13 Gauge FDA UDI

Category: Needle guide, single-use

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

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Also classified as Needle guide, single-use.

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Coaxial needle — Möller Medical GmbH · Class II
Biopsy Starter Kit — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class II
Coaxial needle — Möller Medical GmbH · Class II
Needle Guide — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class II
InnoFine — JingFang Precision Medical Device(Shenzhen) Co., Ltd. · Class II

Cleared under the same submission

K051506 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Myco Medical Supplies Inc.

Sources (1)

FDA UDI 8ceaa67f-5a39-4e00-a44c-4dbcb7c6cd9c 36 fields · synced May 30, 2026