McKesson

FDA UDI

Class II (US FDA UDI)

by Mckesson Medical-Surgical Inc.

Identity

Trade Name: McKesson FDA UDI
Generic Name: Insulin syringe/needle, safety FDA UDI
Device Name: SYRINGE/NDL, SAFETY PREVENT R 3CC 25GX5/8" FDA UDI
Model / Reference: 16-SNR3C2558S FDA UDI
Description: SYRINGE/NDL, SAFETY PREVENT R 3CC 25GX5/8" FDA UDI

Identifiers

Primary DI / UDI-DI: 10612479256795 FDA UDI
510(k) Number: K191490 FDA UDI
FDA Product Code: MEG FDA UDI
GMDN Term: Insulin syringe/needle, safety FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5860 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

Category: Insulin syringe/needle, safety

McKesson by Mckesson Medical-Surgical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Insulin syringe/needle, safety.

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RELI — MYCO MEDICAL SUPPLIES INC. · Class II
ONE-CARE Safety Pen Needles 30G x 8mm, Yellow, — MediVena, LLC · Class II
Endure — ENDURE INDUSTRIES, INC. · Class II
Disposable Insulin Syringe — Berpu Medical Technology Co., Ltd · Class II
RELI — MYCO MEDICAL SUPPLIES INC. · Class II
Disposable Insulin Syringe — Berpu Medical Technology Co., Ltd · Class II
SecureSafe Safety Insulin Syringe — Dynarex Corp. · Class II

Cleared under the same submission

K191490 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: Mckesson Medical-Surgical Inc.

Sources (1)

FDA UDI 23c03cea-107c-4724-b38d-9a7dfae6cfce 34 fields · synced Jun 8, 2026