Syringes with Attached Needle 20ml/cc - 18G x1"

FDA UDI

Class II (US FDA UDI)

by Hepro.us Inc.

Identity

Trade Name: Syringes with Attached Needle 20ml/cc - 18G x1" FDA UDI
Generic Name: General-purpose syringe, single-use FDA UDI
Device Name: HEPRO.US Hypodermic Needle 20ml/cc - 18G x1"–100 pcs per Box-6 per Case FDA UDI
Model / Reference: CT - 20ml/cc - 18G x1" FDA UDI
Description: HEPRO.US Hypodermic Needle 20ml/cc - 18G x1"–100 pcs per Box-6 per Case FDA UDI

Identifiers

Primary DI / UDI-DI: 00854427007605 FDA UDI
FDA Product Code: FMF FDA UDI
GMDN Term: General-purpose syringe, single-use 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

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: General-purpose syringe, single-use

Syringes with Attached Needle 20ml/cc - 18G x1" by Hepro.us Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Hepro.us Inc.

Sources (1)

FDA UDI 9d020bd0-4abc-4cb1-acbc-985ba7df4482 33 fields · synced Jun 1, 2026