Consulting Wallah › Device Explorer › Other devices › Embolization particle, non-bioabsorbable
Device Explorer · FDA GUDID · GMDN 60938

Embolization particle, non-bioabsorbable

A non-bioabsorbable, implantable bead/microsphere intended to be introduced into the peripheral vasculature during an interventional radiology procedure to treat hypervascularized tumours and arteriovenous malformation in a variety of anatomies (e.g., head, ne

US‑registered devices192in commercial distribution
Companies9labelers on GUDID
Single‑use100%of device records
Sterile99%labelled sterile
Prescription50%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Biosphere Medical6433%
Canyon Medical Inc.3619%
Boston Scientific Corporation2915%
Varian Medical Systems, Inc.2614%
Microvention, Inc.158%
Cook Incorporated84%
Merit Medical Systems, Inc.74%
Abk Biomedical Incorporated63%

Top labelers

CompanyDevicesShare
Biosphere Medical6433%
Canyon Medical Inc.3619%
Boston Scientific Corporation2915%
Varian Medical Systems, Inc.2614%
Microvention, Inc.158%
Cook Incorporated84%
Merit Medical Systems, Inc.74%
Abk Biomedical Incorporated63%
Biocompatibles Uk Ltd11%

Company = labeler of record on GUDID. 9 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Polyvinyl Alcohol Embolic MicrospheresLC Bead LUMI 40 - 90LC Bead LUMI 70 - 150LC Bead M1 70-150LC Bead 500-700LC Bead 300-500LC Bead 100-300Bead Block 900-1200Bead Block 700-900Bead Block 500-700Bead Block 300-500Bead Block 100-300Embosphere®QuadraSphere Q2™Embosphere Pro™QuadraSphere®

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

FDA product codes

CodeNameDevices
KRDDevice, Vascular, For Promoting Embolization112
KRDDevice, Vascular, for Promoting Embolization93
NAJAgents, embolic, for treatment of uterine fibroids54
NAJAGENTS,EMBOLIC,FOR TREATMENT OF UTERINE FIBROIDS46
NAJAgents,Embolic,For Treatment Of Uterine Fibroids40
NOYAgents, embolic, for treatment of benign prostatic hyperplas37

GMDN & GCC registration

  • GMDN code 60938 · implantable
  • Single‑use 100% · sterile 99% · Rx‑only 50% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Outer Diameter (Micrometer) · 46

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

No closely related category with 50+ devices.

How many embolization particle, non-bioabsorbable products are registered in the US?

192 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Embolization particle, non-bioabsorbable", from 9 companies. The largest labeler is Biosphere Medical with 33% of records.

Which FDA product codes apply?

KRD (Device, Vascular, For Promoting Embolization), KRD (Device, Vascular, for Promoting Embolization), NAJ (Agents, embolic, for treatment of uterine fibroids), NAJ (AGENTS,EMBOLIC,FOR TREATMENT OF UTERINE FIBROIDS)

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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