FDA.reportPublic FDA data

Invasive breast implant sizer, fixed, reusable

Definition
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 single-lumen, filled with a fixed amount of silicone gel, which is placed in the pocket and then removed. The sizer may vary in shape, profile, and volume. This is a reusable device intended to be resterilized between patient applications.
GUDID devices
76
Last updated
2023-08-03 06:24:11

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
10081317031328MENTOR MemoryGel BOOST Resterilizable Gel SizerMENTOR TEXAS L.P.RSZMHB545S2023-07-26
10081317031342MENTOR MemoryGel BOOST Resterilizable Gel SizerMENTOR TEXAS L.P.RSZMHB150S2023-07-26
10081317031359MENTOR MemoryGel BOOST Resterilizable Gel SizerMENTOR TEXAS L.P.RSZMHB170S2023-07-26
10081317031366MENTOR MemoryGel BOOST Resterilizable Gel SizerMENTOR TEXAS L.P.RSZMHB190S2023-07-26
10081317031373MENTOR MemoryGel BOOST Resterilizable Gel SizerMENTOR TEXAS L.P.RSZMHB210S2023-07-26
10081317031380MENTOR MemoryGel BOOST Resterilizable Gel SizerMENTOR TEXAS L.P.RSZMHB230S2023-07-26
10081317031397MENTOR MemoryGel BOOST Resterilizable Gel SizerMENTOR TEXAS L.P.RSZMHB260S2023-07-26
10081317031403MENTOR MemoryGel BOOST Resterilizable Gel SizerMENTOR TEXAS L.P.RSZMHB280S2023-07-26
10081317031410MENTOR MemoryGel BOOST Resterilizable Gel SizerMENTOR TEXAS L.P.RSZMHB310S2023-07-26
10081317031427MENTOR MemoryGel BOOST Resterilizable Gel SizerMENTOR TEXAS L.P.RSZMHB330S2023-07-26
10081317031434MENTOR MemoryGel BOOST Resterilizable Gel SizerMENTOR TEXAS L.P.RSZMHB355S2023-07-26
10081317031441MENTOR MemoryGel BOOST Resterilizable Gel SizerMENTOR TEXAS L.P.RSZMHB375S2023-07-26
10081317031458MENTOR MemoryGel BOOST Resterilizable Gel SizerMENTOR TEXAS L.P.RSZMHB400S2023-07-26
10081317031465MENTOR MemoryGel BOOST Resterilizable Gel SizerMENTOR TEXAS L.P.RSZMHB435S2023-07-26
10081317031472MENTOR MemoryGel BOOST Resterilizable Gel SizerMENTOR TEXAS L.P.RSZMHB470S2023-07-26
10081317031489MENTOR MemoryGel BOOST Resterilizable Gel SizerMENTOR TEXAS L.P.RSZMHB500S2023-07-26
10081317031496MENTOR MemoryGel BOOST Resterilizable Gel SizerMENTOR TEXAS L.P.RSZMHB580S2023-07-26
10081317031502MENTOR MemoryGel BOOST Resterilizable Gel SizerMENTOR TEXAS L.P.RSZMHB635S2023-07-26
10081317031519MENTOR MemoryGel BOOST Resterilizable Gel SizerMENTOR TEXAS L.P.RSZMHB700S2023-07-26
10081317031526MENTOR MemoryGel BOOST Resterilizable Gel SizerMENTOR TEXAS L.P.RSZMHB775S2023-07-26
00081317027171MENTOR MemoryGel BOOST Resterilizable Gel SizerMENTOR TEXAS L.P.RSZMPB130S2022-02-15
00081317027188MENTOR MemoryGel BOOST Resterilizable Gel SizerMENTOR TEXAS L.P.RSZMPB160S2022-02-15
00081317027195MENTOR MemoryGel BOOST Resterilizable Gel SizerMENTOR TEXAS L.P.RSZMPB185S2022-02-15
00081317027201MENTOR MemoryGel BOOST Resterilizable Gel SizerMENTOR TEXAS L.P.RSZMPB210S2022-02-15
00081317027218MENTOR MemoryGel BOOST Resterilizable Gel SizerMENTOR TEXAS L.P.RSZMPB235S2022-02-15
00081317027225MENTOR MemoryGel BOOST Resterilizable Gel SizerMENTOR TEXAS L.P.RSZMPB265S2022-02-15
00081317027232MENTOR MemoryGel BOOST Resterilizable Gel SizerMENTOR TEXAS L.P.RSZMPB290S2022-02-15
00081317027249MENTOR MemoryGel BOOST Resterilizable Gel SizerMENTOR TEXAS L.P.RSZMPB320S2022-02-15
00081317027256MENTOR MemoryGel BOOST Resterilizable Gel SizerMENTOR TEXAS L.P.RSZMPB340S2022-02-15
00081317027263MENTOR MemoryGel BOOST Resterilizable Gel SizerMENTOR TEXAS L.P.RSZMPB390S2022-02-15
00081317027270MENTOR MemoryGel BOOST Resterilizable Gel SizerMENTOR TEXAS L.P.RSZMPB430S2022-02-15
00081317027287MENTOR MemoryGel BOOST Resterilizable Gel SizerMENTOR TEXAS L.P.RSZMPB450S2022-02-15
00081317027294MENTOR MemoryGel BOOST Resterilizable Gel SizerMENTOR TEXAS L.P.RSZMPB480S2022-02-15
00081317027300MENTOR MemoryGel BOOST Resterilizable Gel SizerMENTOR TEXAS L.P.RSZMPB530S2022-02-15
00081317027317MENTOR MemoryGel BOOST Resterilizable Gel SizerMENTOR TEXAS L.P.RSZMPB545S2022-02-15
00081317027324MENTOR MemoryGel BOOST Resterilizable Gel SizerMENTOR TEXAS L.P.RSZMPB590S2022-02-15
00081317027331MENTOR MemoryGel BOOST Resterilizable Gel SizerMENTOR TEXAS L.P.RSZMPB630S2022-02-15
00081317027348MENTOR MemoryGel BOOST Resterilizable Gel SizerMENTOR TEXAS L.P.RSZMPB675S2022-02-15
00081317027355MENTOR MemoryGel BOOST Resterilizable Gel SizerMENTOR TEXAS L.P.RSZMPB730S2022-02-15
00081317027386MENTOR MemoryGel BOOST Resterilizable Gel SizerMENTOR TEXAS L.P.RSZHPB200S2022-02-15
00081317027393MENTOR MemoryGel BOOST Resterilizable Gel SizerMENTOR TEXAS L.P.RSZHPB235S2022-02-15
00081317027409MENTOR MemoryGel BOOST Resterilizable Gel SizerMENTOR TEXAS L.P.RSZHPB260S2022-02-15
00081317027416MENTOR MemoryGel BOOST Resterilizable Gel SizerMENTOR TEXAS L.P.RSZHPB285S2022-02-15
00081317027430MENTOR MemoryGel BOOST Resterilizable Gel SizerMENTOR TEXAS L.P.RSZHPB370S2022-02-15
00081317027447MENTOR MemoryGel BOOST Resterilizable Gel SizerMENTOR TEXAS L.P.RSZHPB405S2022-02-15
00081317027454MENTOR MemoryGel BOOST Resterilizable Gel SizerMENTOR TEXAS L.P.RSZHPB440S2022-02-15
00081317027461MENTOR MemoryGel BOOST Resterilizable Gel SizerMENTOR TEXAS L.P.RSZHPB480S2022-02-15
00081317027478MENTOR MemoryGel BOOST Resterilizable Gel SizerMENTOR TEXAS L.P.RSZHPB520S2022-02-15
00081317027485MENTOR MemoryGel BOOST Resterilizable Gel SizerMENTOR TEXAS L.P.RSZHPB545S2022-02-15
00081317027492MENTOR MemoryGel BOOST Resterilizable Gel SizerMENTOR TEXAS L.P.RSZHPB585S2022-02-15
00081317027508MENTOR MemoryGel BOOST Resterilizable Gel SizerMENTOR TEXAS L.P.RSZHPB635S2022-02-15
00081317027515MENTOR MemoryGel BOOST Resterilizable Gel SizerMENTOR TEXAS L.P.RSZHPB685S2022-02-15
00081317027522MENTOR MemoryGel BOOST Resterilizable Gel SizerMENTOR TEXAS L.P.RSZHPB740S2022-02-15
00081317027539MENTOR MemoryGel BOOST Resterilizable Gel SizerMENTOR TEXAS L.P.RSZHPB775S2022-02-15
10081317030666MENTOR MemoryGel BOOST Resterilizable Gel SizerMENTOR TEXAS L.P.RSZHPB325S2022-02-15
10081317027949MENTOR MemoryGel Xtra Resterilizable Gel SizerMENTOR TEXAS L.P.RSZSMHX130S2021-02-01
10081317027956MENTOR MemoryGel Xtra Resterilizable Gel SizerMENTOR TEXAS L.P.RSZSMHX150S2021-02-01
10081317027963MENTOR MemoryGel Xtra Resterilizable Gel SizerMENTOR TEXAS L.P.RSZSMHX170S2021-02-01
10081317027970MENTOR MemoryGel Xtra Resterilizable Gel SizerMENTOR TEXAS L.P.RSZSMHX185S2021-02-01
10081317027987MENTOR MemoryGel Xtra Resterilizable Gel SizerMENTOR TEXAS L.P.RSZSMHX210S2021-02-01
10081317027994MENTOR MemoryGel Xtra Resterilizable Gel SizerMENTOR TEXAS L.P.RSZSMHX230S2021-02-01
10081317028007MENTOR MemoryGel Xtra Resterilizable Gel SizerMENTOR TEXAS L.P.RSZSMHX255S2021-02-01
10081317028014MENTOR MemoryGel Xtra Resterilizable Gel SizerMENTOR TEXAS L.P.RSZSMHX280S2021-02-01
10081317028021MENTOR MemoryGel Xtra Resterilizable Gel SizerMENTOR TEXAS L.P.RSZSMHX310S2021-02-01
10081317028038MENTOR MemoryGel Xtra Resterilizable Gel SizerMENTOR TEXAS L.P.RSZSMHX330S2021-02-01
10081317028045MENTOR MemoryGel Xtra Resterilizable Gel SizerMENTOR TEXAS L.P.RSZSMHX350S2021-02-01
10081317028052MENTOR MemoryGel Xtra Resterilizable Gel SizerMENTOR TEXAS L.P.RSZSMHX375S2021-02-01
10081317028069MENTOR MemoryGel Xtra Resterilizable Gel SizerMENTOR TEXAS L.P.RSZSMHX400S2021-02-01
10081317028076MENTOR MemoryGel Xtra Resterilizable Gel SizerMENTOR TEXAS L.P.RSZSMHX430S2021-02-01
10081317028083MENTOR MemoryGel Xtra Resterilizable Gel SizerMENTOR TEXAS L.P.RSZSMHX470S2021-02-01
10081317028090MENTOR MemoryGel Xtra Resterilizable Gel SizerMENTOR TEXAS L.P.RSZSMHX500S2021-02-01
10081317028106MENTOR MemoryGel Xtra Resterilizable Gel SizerMENTOR TEXAS L.P.RSZSMHX545S2021-02-01
10081317028113MENTOR MemoryGel Xtra Resterilizable Gel SizerMENTOR TEXAS L.P.RSZSMHX580S2021-02-01
10081317028120MENTOR MemoryGel Xtra Resterilizable Gel SizerMENTOR TEXAS L.P.RSZSMHX630S2021-02-01
10081317028137MENTOR MemoryGel Xtra Resterilizable Gel SizerMENTOR TEXAS L.P.RSZSMHX700S2021-02-01
10081317028144MENTOR MemoryGel Xtra Resterilizable Gel SizerMENTOR TEXAS L.P.RSZSMHX775S2021-02-01