Device Explorer · FDA GUDID · GMDN 17812

Needle guard

A cap/cover intended to be extended over a used needle (attached to a syringe/autoinjector or not) to prevent accidental needle sticks, typically during removal of the needle. It is typically a plastic housing with appropriate shielding to prevent injury upon

US‑registered devices96in commercial distribution
Companies10labelers on GUDID
Single‑use98%of device records
Sterile79%labelled sterile
Prescription89%Rx‑only share
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Share of device records

Sol-Millennium Medical, Inc.6871%
Aspen Surgical Products, Inc.55%
Med Saver, Inc.55%
Beekley Corporation44%
Icu Medical, Inc.44%
Novo Surgical, Inc.33%
Itl Asia Pacific Sdn. Bhd.33%
Cardinal Health 200, Llc22%

Top labelers

CompanyDevicesShare
Sol-Millennium Medical, Inc.6871%
Aspen Surgical Products, Inc.55%
Med Saver, Inc.55%
Beekley Corporation44%
Icu Medical, Inc.44%
Novo Surgical, Inc.33%
Itl Asia Pacific Sdn. Bhd.33%
Cardinal Health 200, Llc22%
Retractable Technologies, Inc.11%
Medline Industries, Inc.11%

Company = labeler of record on GUDID. 10 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Novo Surgical Inc.Oxboro™ Pin CoverSOL-CARE Safety NeedleSOL-CARE™ Safety Blood Collection NeedleSOL-GUARD™ TB Safety Syringe with Fixed NeedleSOL-CARE™ Safety Blood Collection Needle w/Pre-aSOL-CARE™ Luer Lock Syringe w/Safety NeedleSOL-CARE™ Safety NeedleSOL-GUARD™ Insulin Safety Syringe with Fixed NeeSOL-CARE™ Luer Lock Syringe with Safety NeedlePinnacleCradlesPointGuardsEasyPoint®MSI Precision Specialty InstrumentsBCI

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

FDA product codes

CodeNameDevices
FMINeedle, hypodermic, single lumen47
JKATubes, vials, systems, serum separators, blood collection17
FMFSyringe, piston17
MEGSYRINGE, ANTISTICK12
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT10
FPASet, administration, intravascular5

GMDN & GCC registration

  • GMDN code 17812 · non‑implantable
  • Single‑use 98% · sterile 79% · Rx‑only 89% · OTC 4%
  • 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) · 68Needle Gauge (Gauge) · 68Total Volume (Milliliter) · 29Length (Inch) · 2Outer Diameter (Millimeter) · 1

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

How many needle guard products are registered in the US?

96 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Needle guard", from 10 companies. The largest labeler is Sol-Millennium Medical, Inc. with 71% of records.

Which FDA product codes apply?

FMI (Needle, hypodermic, single lumen), JKA (Tubes, vials, systems, serum separators, blood collection), FMF (Syringe, piston), MEG (SYRINGE, ANTISTICK)

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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