FDA.reportPublic FDA data

Invasive breast implant sizer, fixed, single-use

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 consists of a balloon-like elastomer shell that is either filled to an optimal volume via tubing and port, or is prefilled 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 single-use device.
GUDID devices
592
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
10888628044982NATRELLE INSPIRA Single Use Sizers Allergan, Inc.SSZ-F1802022-01-06
10888628044999NATRELLE INSPIRA Single Use Sizers Allergan, Inc.SSZ-F2002022-01-06
10888628045002NATRELLE INSPIRA Single Use Sizers Allergan, Inc.SSZ-F2202022-01-06
10888628045019NATRELLE INSPIRA Single Use Sizers Allergan, Inc.SSZ-F2402022-01-06
10888628045026NATRELLE INSPIRA Single Use Sizers Allergan, Inc.SSZ-F2652022-01-06
10888628045033NATRELLE INSPIRA Single Use Sizers Allergan, Inc.SSZ-F2952022-01-06
10888628045194NATRELLE INSPIRA Single Use Sizers Allergan, Inc.SSZ-L1102022-01-05
10888628045200NATRELLE INSPIRA Single Use Sizers Allergan, Inc.SSZ-L1252022-01-05
10888628045217NATRELLE INSPIRA Single Use Sizers Allergan, Inc.SSZ-L1402022-01-05
10888628045224NATRELLE INSPIRA Single Use Sizers Allergan, Inc.SSZ-L1702022-01-05
10888628045231NATRELLE INSPIRA Single Use Sizers Allergan, Inc.SSZ-L2002022-01-05
10888628045248NATRELLE INSPIRA Single Use Sizers Allergan, Inc.SSZ-L2302022-01-05
10888628045255NATRELLE INSPIRA Single Use Sizers Allergan, Inc.SSZ-L2602022-01-05
10888628045262NATRELLE INSPIRA Single Use Sizers Allergan, Inc.SSZ-L2902022-01-05
10888628045279NATRELLE INSPIRA Single Use Sizers Allergan, Inc.SSZ-L3202022-01-05
10888628045286NATRELLE INSPIRA Single Use Sizers Allergan, Inc.SSZ-L3502022-01-05
10888628045293NATRELLE INSPIRA Single Use Sizers Allergan, Inc.SSZ-L3802022-01-05
10888628045309NATRELLE INSPIRA Single Use Sizers Allergan, Inc.SSZ-L4102022-01-05
10888628045316NATRELLE INSPIRA Single Use Sizers Allergan, Inc.SSZ-L4602022-01-06
10888628045323NATRELLE INSPIRA Single Use Sizers Allergan, Inc.SSZ-L5102022-01-06
10888628045330NATRELLE INSPIRA Single Use Sizers Allergan, Inc.SSZ-L5602022-01-06
10888628045347NATRELLE INSPIRA Single Use Sizers Allergan, Inc.SSZ-L6102022-01-06
10888628045354NATRELLE INSPIRA Single Use Sizers Allergan, Inc.SSZ-LP1252022-01-06
10888628045361NATRELLE INSPIRA Single Use Sizers Allergan, Inc.SSZ-LP1452022-01-06
10888628045378NATRELLE INSPIRA Single Use Sizers Allergan, Inc.SSZ-LP1652022-01-06
10888628045385NATRELLE INSPIRA Single Use Sizers Allergan, Inc.SSZ-LP1902022-01-06
10888628045392NATRELLE INSPIRA Single Use Sizers Allergan, Inc.SSZ-LP2052022-01-06
10888628045408NATRELLE INSPIRA Single Use Sizers Allergan, Inc.SSZ-LP2202022-01-06
10888628045415NATRELLE INSPIRA Single Use Sizers Allergan, Inc.SSZ-LP2352022-01-06
10888628045422NATRELLE INSPIRA Single Use Sizers Allergan, Inc.SSZ-LP2502022-01-06
10888628045439NATRELLE INSPIRA Single Use Sizers Allergan, Inc.SSZ-LP2652022-01-06
10888628045446NATRELLE INSPIRA Single Use Sizers Allergan, Inc.SSZ-LP2802022-01-06
10888628045453NATRELLE INSPIRA Single Use Sizers Allergan, Inc.SSZ-LP3002022-01-06
10888628045460NATRELLE INSPIRA Single Use Sizers Allergan, Inc.SSZ-LP3202022-01-06
10888628045477NATRELLE INSPIRA Single Use Sizers Allergan, Inc.SSZ-LP3402022-01-06
10888628045484NATRELLE INSPIRA Single Use Sizers Allergan, Inc.SSZ-LP3602022-01-06
10888628045491NATRELLE INSPIRA Single Use Sizers Allergan, Inc.SSZ-LP4002022-01-06
10888628045507NATRELLE INSPIRA Single Use Sizers Allergan, Inc.SSZ-LP4402022-01-06
10888628045514NATRELLE INSPIRA Single Use Sizers Allergan, Inc.SSZ-LP4902022-01-06
10888628045521NATRELLE INSPIRA Single Use Sizers Allergan, Inc.SSZ-LP5402022-01-06
10888628045538NATRELLE INSPIRA Single Use Sizers Allergan, Inc.SSZ-LP5902022-01-06
10888628045545NATRELLE INSPIRA Single Use Sizers Allergan, Inc.SSZ-LP6402022-01-06
10888628045552NATRELLE INSPIRA Single Use Sizers Allergan, Inc.SSZ-M1402022-01-06
10888628045569NATRELLE INSPIRA Single Use Sizers Allergan, Inc.SSZ-M1752022-01-06
10888628045576NATRELLE INSPIRA Single Use Sizers Allergan, Inc.SSZ-M1952022-01-06
10888628045583NATRELLE INSPIRA Single Use Sizers Allergan, Inc.SSZ-M2102022-01-06
10888628045590NATRELLE INSPIRA Single Use Sizers Allergan, Inc.SSZ-M2402022-01-06
10888628045606NATRELLE INSPIRA Single Use Sizers Allergan, Inc.SSZ-M2552022-01-06
10888628045613NATRELLE INSPIRA Single Use Sizers Allergan, Inc.SSZ-M2752022-01-06
10888628045620NATRELLE INSPIRA Single Use Sizers Allergan, Inc.SSZ-M2952022-01-06
10888628045637NATRELLE INSPIRA Single Use Sizers Allergan, Inc.SSZ-M3102022-01-06
10888628045644NATRELLE INSPIRA Single Use Sizers Allergan, Inc.SSZ-M3302022-01-06
10888628045651NATRELLE INSPIRA Single Use Sizers Allergan, Inc.SSZ-M3452022-01-06
10888628045668NATRELLE INSPIRA Single Use Sizers Allergan, Inc.SSZ-M3602022-01-06
10888628045675NATRELLE INSPIRA Single Use Sizers Allergan, Inc.SSZ-M3752022-01-06
10888628045682NATRELLE INSPIRA Single Use Sizers Allergan, Inc.SSZ-M4052022-01-06
10888628045699NATRELLE INSPIRA Single Use Sizers Allergan, Inc.SSZ-M4452022-01-06
10888628045705NATRELLE INSPIRA Single Use Sizers Allergan, Inc.SSZ-M4852022-01-06
10888628045712NATRELLE INSPIRA Single Use Sizers Allergan, Inc.SSZ-M5202022-01-06
10888628045729NATRELLE INSPIRA Single Use Sizers Allergan, Inc.SSZ-M5602022-01-06
10888628045736NATRELLE INSPIRA Single Use Sizers Allergan, Inc.SSZ-M6002022-01-06
10888628045743NATRELLE INSPIRA Single Use Sizers Allergan, Inc.SSZ-M6402022-01-06
10888628045750NATRELLE INSPIRA Single Use Sizers Allergan, Inc.SSZ-M6852022-01-06
10888628045767NATRELLE INSPIRA Single Use Sizers Allergan, Inc.SSZ-M7552022-01-06
10081317032684MENTOR MemoryGel Enhance Single Use Gel Sizer Ultra High ProfileMENTOR TEXAS L.P.SZUHE10302025-04-01
10081317032691MENTOR MemoryGel Enhance Single Use Gel Sizer Ultra High ProfileMENTOR TEXAS L.P.SZUHE11352025-04-01
10081317032707MENTOR MemoryGel Enhance Single Use Gel Sizer Ultra High ProfileMENTOR TEXAS L.P.SZUHE12402025-04-01
10081317032714MENTOR MemoryGel Enhance Single Use Gel Sizer Ultra High ProfileMENTOR TEXAS L.P.SZUHE13402025-04-01
10081317032721MENTOR MemoryGel Enhance Single Use Gel Sizer Ultra High ProfileMENTOR TEXAS L.P.SZUHE14452025-04-01
10081317032738MENTOR MemoryGel Enhance Single Use Gel Sizer Ultra High ProfileMENTOR TEXAS L.P.SZUHE9302025-04-01
00810076890319SIENTRA Silicone Gel Breast Implant SizerSientra, Inc.GS10712-080MP2023-08-14
00810076890326SIENTRA Silicone Gel Breast Implant SizerSientra, Inc.GS10712-100MP2023-08-14
00810076890333SIENTRA Silicone Gel Breast Implant SizerSientra, Inc.GS10712-120MP2023-08-14
00810076890340SIENTRA Silicone Gel Breast Implant SizerSientra, Inc.GS10712-150MP2023-08-14
00810076890357SIENTRA Silicone Gel Breast Implant SizerSientra, Inc.GS10712-170MP2023-08-14
00810076890364SIENTRA Silicone Gel Breast Implant SizerSientra, Inc.GS10712-190MP2023-08-14
00810076890371SIENTRA Silicone Gel Breast Implant SizerSientra, Inc.GS10712-210MP2023-08-14
00810076890388SIENTRA Silicone Gel Breast Implant SizerSientra, Inc.GS10712-230MP2023-08-14
00810076890395SIENTRA Silicone Gel Breast Implant SizerSientra, Inc.GS10712-250MP2023-08-14
00810076890401SIENTRA Silicone Gel Breast Implant SizerSientra, Inc.GS10712-270MP2023-08-14