Consulting Wallah › Device Explorer › Syringes, needles & infusion › Syringe-loaded medication/vaccine injector, manual
Device Explorer · FDA GUDID · GMDN 12132

Syringe-loaded medication/vaccine injector, manual, professional

A hand-held, manually-powered mechanical device intended to be used in conjunction with a standard plunger syringe and needle to administer an injection of medication or vaccine to a patient intramuscularly (IM) and/or subcutaneously; it is not intended for in

US‑registered devices54in commercial distribution
Companies17labelers on GUDID
Single‑use54%of device records
Sterile46%labelled sterile
Prescription52%Rx‑only share
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Share of device records

Neochild, Llc2343%
Septodont, Inc815%
Owen Mumford Limited47%
Integra Lifesciences Production Corporation47%
Novo Surgical, Inc.24%
Burkhart Dental Supply Co., The24%
Phillips-Medisize A/S12%
Dermato Plastica Beauty Co., Ltd.12%

Top labelers

CompanyDevicesShare
Neochild, Llc2343%
Septodont, Inc815%
Owen Mumford Limited47%
Integra Lifesciences Production Corporation47%
Novo Surgical, Inc.24%
Burkhart Dental Supply Co., The24%
Phillips-Medisize A/S12%
Dermato Plastica Beauty Co., Ltd.12%
Slanted Adaptor Llc12%
Bound Tree Medical, Llc12%
Cole Instruments Inc12%
Ace Surgical Supply Co., Inc.12%

Company = labeler of record on GUDID. 17 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

BETACONNECTDPB (Dermato Plastica Beauty Co., Ltd.)SyringeProNovo Surgical Inc.Burkhart Aspirating Syringe - Astra StyleBurkhart Aspriating Syringe - Cook Waite StyleCuraplexSelf-Filling DeviceACE Surgical SupplyPetfine Autoject 2Autoject 2Autoject EISUSTOL Co-packaged KitWhisperjectSEPTODONT ECO-CW ASPIRATING SYR WINGEDSEPTODONT ECO-A ASPIRATING SYR WINGLESS

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
FMFSyringe, Piston22
EJISyringe, Cartridge11
KZHIntroducer, Syringe Needle8
MDMInstrument, Manual, Surgical, General Use2
IQGAdaptor, Holder, Syringe2
KCPSyringe, Ent2

GMDN & GCC registration

  • GMDN code 12132 · non‑implantable
  • Single‑use 54% · sterile 46% · Rx‑only 52% · OTC 13%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Millimeter) · 5Width (Millimeter) · 4Length (Inch) · 2Total Volume (Milliliter) · 2Width (Micrometer) · 1Width (Inch) · 1

Use these as the dimensions to specify in a tender line.

How many syringe-loaded medication/vaccine injector, manual, professional products are registered in the US?

54 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Syringe-loaded medication/vaccine injector, manual, professional", from 17 companies. The largest labeler is Neochild, Llc with 43% of records.

Which FDA product codes apply?

FMF (Syringe, Piston), EJI (Syringe, Cartridge), KZH (Introducer, Syringe Needle), MDM (Instrument, Manual, Surgical, General Use)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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