HEPRO.US Hypodermic Needle 10ml/cc 18G x 1”

FDA UDI

Class II (US FDA UDI)

by Hepro.us Inc.

Identity

Trade Name: HEPRO.US Hypodermic Needle 10ml/cc 18G x 1” FDA UDI
Generic Name: General-purpose syringe, single-use FDA UDI
Device Name: HEPRO.US Hypodermic Needle 10ml/cc 18G x 1”-100pcs 6 Boxes Case FDA UDI
Model / Reference: CT - 10ml/cc 18G x 1" FDA UDI
Description: HEPRO.US Hypodermic Needle 10ml/cc 18G x 1”-100pcs 6 Boxes Case FDA UDI

Identifiers

Primary DI / UDI-DI: 00854427007599 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

HEPRO.US Hypodermic Needle 10ml/cc 18G x 1” by Hepro.us Inc. — 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

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Hepro.us Inc.

Sources (1)

FDA UDI c8e33a95-b702-4840-935c-a8a1392305f1 33 fields · synced Jun 1, 2026