← Back to catalogue

Hands Free Syringe

FDA UDI

Class II (US FDA UDI)

by Concert Medical, Llc

Identity

Trade Name
Hands Free Syringe FDA UDI
Generic Name
Pain management medication delivery system FDA UDI
Device Name
Pouch of 1 sterile 20 mL syringe, stored inside a box of 20 FDA UDI
Model / Reference
HFS-SYR FDA UDI
Description
Pouch of 1 sterile 20 mL syringe, stored inside a box of 20 FDA UDI

Identifiers

Catalog Number
411987-001 FDA UDI
Primary DI / UDI-DI
00814384020383 FDA UDI
FDA Product Code
FRN FDA UDI
GMDN Term
Pain management medication delivery system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5725 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Pain management medication delivery system

Hands Free Syringe by Concert Medical, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Pain management medication delivery system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
Concert Medical, Llc

Sources (1)

  • FDA UDI ebef4888-2c3d-4642-a57f-413cf8f48483 35 fields · synced Jun 1, 2026