Surgyco

FDA UDI

Class II (US FDA UDI)

by Surgyco LLC

Identity

Trade Name: SURGYCO FDA UDI
Generic Name: General-purpose syringe, single-use FDA UDI
Device Name: Surgyco Disposable Face Mask Level 3 With Plastic Shield with Ties FDA UDI
Model / Reference: PS011535T FDA UDI
Description: Surgyco Disposable Face Mask Level 3 With Plastic Shield with Ties FDA UDI

Identifiers

Primary DI / UDI-DI: 10850053289696 FDA UDI
510(k) Number: K210433 FDA UDI
FDA Product Code: FXX FDA UDI
GMDN Term: General-purpose syringe, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4040 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

Yes

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: General-purpose syringe, single-use

Surgyco by Surgyco LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

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NAMIC — MEDLINE INDUSTRIES, INC. · Class II
HSW HENKE-JECT® — Henke-Sass, Wolf GmbH · Class II
BD Safety-Lok — BECTON DICKINSON AND COMPANY · Class II
Merit Medical® — Merit Medical Systems, Inc. · Class II
Merit Medical® — Merit Medical Systems, Inc. · Class II

Cleared under the same submission

K210433 also covers:

SURGYCO — Surgyco LLC
SURGYCO — Surgyco LLC

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: Surgyco LLC

Sources (1)

FDA UDI e6252aef-9d24-415c-a3c6-e1a9e377759d 34 fields · synced May 31, 2026