Invasive breast implant sizer, fixed, single-use — 667 US-registered devices, 5 companies, FDA product codes | Device Explorer

Name: Invasive breast implant sizer, fixed, single-use — US-registered devices
Creator: Consulting Wallah
License: https://creativecommons.org/licenses/by-nc-nd/4.0/

Share of device records

Sientra, Inc.22834%

Specialty Surgical Products Inc13921%

Mentor Texas L.P.12018%

Allergan, Inc.10015%

Establishment Labs S.A.8012%

Top labelers

Company	Devices	Share
Sientra, Inc.	228	34%
Specialty Surgical Products Inc	139	21%
Mentor Texas L.P.	120	18%
Allergan, Inc.	100	15%
Establishment Labs S.A.	80	12%

Company = labeler of record on GUDID. 5 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Motiva Implant MatrixSIENTRA Silicone Gel Breast Implant SizerOPUS Silicone Gel Breast Implant SizerMENTOR Round High Profile Single Use Saline BreaMENTOR Round Moderate Plus Profile Single Use SaMENTOR Round Moderate Profile Single Use Saline Single Use Sterile Saline Breast Implant Sizer fSingle Use Sterile Saline Breast Implant Sizer fSingle Use Sterile Saline Breast Implant Sizer fShaped Breast Implant Sizer, Classic Base, ModerShaped Breast Implant Sizer, Round Base, High PrShaped Breast Implant Sizer, Oval Base, ModerateShaped Breast Implant Sizer, Oval Base, High ProRound Breast Implant Sizer, High ProjectionRound Breast Implant Sizer, Moderate Plus ProjecSingle Use Mammary Sizer

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

FDA product codes

Code	Name	Devices
MRD	Sizer, Mammary, Breast Implant Volume	557
MRD	Mammary sizer	82
MRD	SIZER, MAMMARY, BREAST IMPLANT VOLUME	43

GMDN & GCC registration

GMDN code 34178 · non‑implantable
Single‑use 100% · sterile 100% · Rx‑only 88% · 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.

Invasive blood pressure transducer set816 devices · 11 companies

Invasive breast implant sizer, fixed, reusable488 devices · 2 companies

How many invasive breast implant sizer, fixed, single-use products are registered in the US?

667 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, single-use", from 5 companies. The largest labeler is Sientra, Inc. with 34% of records.

Which FDA product codes apply?

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

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.