Rospital Prductos Medicos

FDA UDI

Class II (US FDA UDI)

by Atlas Medical Products Llc

Identity

Trade Name: Rospital Prductos Medicos FDA UDI
Generic Name: Hypodermic needle, single-use FDA UDI
Device Name: HYPODERMIC SAFETY NEEDLES 20G X 1 1/2",EA. FDA UDI
Model / Reference: SFYN205 FDA UDI
Description: HYPODERMIC SAFETY NEEDLES 20G X 1 1/2",EA. FDA UDI

Identifiers

Catalog Number: SFYN205 FDA UDI
Primary DI / UDI-DI: 00812460027226 FDA UDI
510(k) Number: K190183 FDA UDI
FDA Product Code: FMI FDA UDI
GMDN Term: Hypodermic needle, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 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

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

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Also classified as Hypodermic needle, single-use.

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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 27175a26-9a14-480d-962d-84016778f82d 37 fields · synced May 30, 2026