Rospital Productos Medicos

FDA UDI

Class II (US FDA UDI)

by Atlas Medical Products Llc

Identity

Trade Name: Rospital Productos Medicos FDA UDI
Generic Name: Hypodermic needle, single-use FDA UDI
Device Name: HYPODERMIC SAFETY NEEDLE WITH 3CC SYRINGE LUER LOCK 21G X 1 1/2, EA. FDA UDI
Model / Reference: SYFTY3215 FDA UDI
Description: HYPODERMIC SAFETY NEEDLE WITH 3CC SYRINGE LUER LOCK 21G X 1 1/2, EA. FDA UDI

Identifiers

Catalog Number: SYFTY3215 FDA UDI
Primary DI / UDI-DI: 00812460027127 FDA UDI
510(k) Number: K190183 FDA UDI
FDA Product Code: FMF FDA UDI
FMI FDA UDI
GMDN Term: Hypodermic needle, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5860 FDA UDI
880.5570 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: Hypodermic needle, single-use General-purpose syringe, single-use

Rospital Productos Medicos by Atlas Medical Products Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General-purpose syringe, single-use.

Merit Medical® — Merit Medical Systems, Inc. · Class II
SOFT-JECT® — Henke-Sass, Wolf GmbH · Class II
CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
SURGYCO — Surgyco LLC · Class I
NAMIC — MEDLINE INDUSTRIES, INC. · Class II
HSW HENKE-JECT® — Henke-Sass, Wolf GmbH · Class II
BD Safety-Lok — BECTON DICKINSON AND COMPANY · Class II
SURGYCO — Surgyco LLC · Class I

Cleared under the same submission

K190183 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: Atlas Medical Products Llc

Sources (1)

FDA UDI 4ff804c8-26ff-41a5-892e-0e02b0d057b2 37 fields · synced Jun 1, 2026