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Device Explorer · FDA GUDID · GMDN 58856

Invasive breast implant sizer, fixed, reusable

A device intended to be placed intraoperatively in a surgically-prepared mammary pocket to provide a volume measurement for the appropriate selection of a breast implant (mammary prosthesis). The device is typically composed of a silicone rubber shell with a s

US‑registered devices488in commercial distribution
Companies2labelers on GUDID
Single‑use0%of device records
Sterile100%labelled sterile
Prescription100%Rx‑only share
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Share of device records

Mentor Texas L.P.31064%
Allergan, Inc.17836%

Top labelers

CompanyDevicesShare
Mentor Texas L.P.31064%
Allergan, Inc.17836%

Company = labeler of record on GUDID. 2 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

MENTOR MemoryGel BOOST Resterilizable Gel SizerMENTOR MemoryGel Xtra Resterilizable Gel SizerMENTOR MemoryShape Resterilizable Gel SizerMENTOR MemoryShape TM Plus Resterilizable Gel SiMENTOR MemoryShape LM Plus Resterilizable Gel SiMENTOR MemoryShape MH Resterilizable Gel SizerMENTOR MemoryShape MM Plus Resterilizable Gel SiMENTOR MemoryShape MM Resterilizable Gel SizerMENTOR MemoryGel Resterilizable Gel SizerNatrelle INSPIRA Resterilizable SizersNATRELLE Resterilizable Breast Implant Sizers

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

FDA product codes

CodeNameDevices
MRDSIZER, MAMMARY, BREAST IMPLANT VOLUME290
MRDSizer, Mammary, Breast Implant Volume218
MRDMammary Sizer178
MRDMammary sizer20

GMDN & GCC registration

  • GMDN code 58856 · non‑implantable
  • Single‑use 0% · sterile 100% · Rx‑only 100% · 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

No structured size data on the register.

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

How many invasive breast implant sizer, fixed, reusable products are registered in the US?

488 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Invasive breast implant sizer, fixed, reusable", from 2 companies. The largest labeler is Mentor Texas L.P. with 64% of records.

Which FDA product codes apply?

MRD (SIZER, MAMMARY, BREAST IMPLANT VOLUME), MRD (Sizer, Mammary, Breast Implant Volume), MRD (Mammary Sizer), MRD (Mammary sizer)

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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