FDA.reportPublic FDA data

MENTOR MemoryGel BOOST Resterilizable Gel Sizer

Primary DI
10081317031342
Brand
MENTOR MemoryGel BOOST Resterilizable Gel Sizer
Company
MENTOR TEXAS L.P.
Model
RSZMHB150S
Catalog number
RSZ-MHB-150S
Device description
Moderate High Profile BOOST, For Use With SMHB-150
Published
2023-07-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MRDMammary sizer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRDMammary SizerUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K062421000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062421000MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZERMentor Corporation2006-10-10MRD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10081317031342PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1008131703134210081317031342

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)235-5731xx@xx.xx

Regulatory Flags#

DUNS number
167450993
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00081317023487Coleman Luer Lock CapCOL-LLCAPCOL-LLCAP2016-09-14
00081317027171MENTOR MemoryGel BOOST Resterilizable Gel SizerRSZMPB130SRSZ-MPB-130S2022-02-15
00081317027188MENTOR MemoryGel BOOST Resterilizable Gel SizerRSZMPB160SRSZ-MPB-160S2022-02-15
00081317027195MENTOR MemoryGel BOOST Resterilizable Gel SizerRSZMPB185SRSZ-MPB-185S2022-02-15
00081317027201MENTOR MemoryGel BOOST Resterilizable Gel SizerRSZMPB210SRSZ-MPB-210S2022-02-15
00081317027218MENTOR MemoryGel BOOST Resterilizable Gel SizerRSZMPB235SRSZ-MPB-235S2022-02-15
00081317027225MENTOR MemoryGel BOOST Resterilizable Gel SizerRSZMPB265SRSZ-MPB-265S2022-02-15
00081317027232MENTOR MemoryGel BOOST Resterilizable Gel SizerRSZMPB290SRSZ-MPB-290S2022-02-15
00081317027249MENTOR MemoryGel BOOST Resterilizable Gel SizerRSZMPB320SRSZ-MPB-320S2022-02-15
00081317027256MENTOR MemoryGel BOOST Resterilizable Gel SizerRSZMPB340SRSZ-MPB-340S2022-02-15
00081317027263MENTOR MemoryGel BOOST Resterilizable Gel SizerRSZMPB390SRSZ-MPB-390S2022-02-15
00081317027270MENTOR MemoryGel BOOST Resterilizable Gel SizerRSZMPB430SRSZ-MPB-430S2022-02-15
00081317027287MENTOR MemoryGel BOOST Resterilizable Gel SizerRSZMPB450SRSZ-MPB-450S2022-02-15
00081317027294MENTOR MemoryGel BOOST Resterilizable Gel SizerRSZMPB480SRSZ-MPB-480S2022-02-15
00081317027300MENTOR MemoryGel BOOST Resterilizable Gel SizerRSZMPB530SRSZ-MPB-530S2022-02-15
00081317027317MENTOR MemoryGel BOOST Resterilizable Gel SizerRSZMPB545SRSZ-MPB-545S2022-02-15
00081317027324MENTOR MemoryGel BOOST Resterilizable Gel SizerRSZMPB590SRSZ-MPB-590S2022-02-15
00081317027331MENTOR MemoryGel BOOST Resterilizable Gel SizerRSZMPB630SRSZ-MPB-630S2022-02-15
00081317027348MENTOR MemoryGel BOOST Resterilizable Gel SizerRSZMPB675SRSZ-MPB-675S2022-02-15
00081317027355MENTOR MemoryGel BOOST Resterilizable Gel SizerRSZMPB730SRSZ-MPB-730S2022-02-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10081317031052MENTOR MemoryGel Enhance Breast ImplantMENTOR TEXAS L.P.MRD2025-04-01
10081317031069MENTOR MemoryGel Enhance Breast ImplantMENTOR TEXAS L.P.MRD2025-04-01
10081317031076MENTOR MemoryGel Enhance Breast ImplantMENTOR TEXAS L.P.MRD2025-04-01
10081317031083MENTOR MemoryGel Enhance Breast ImplantMENTOR TEXAS L.P.MRD2025-04-01
10081317031090MENTOR MemoryGel Enhance Breast ImplantMENTOR TEXAS L.P.MRD2025-04-01
10081317031106MENTOR MemoryGel Enhance Breast ImplantMENTOR TEXAS L.P.MRD2025-04-01
10081317032684MENTOR MemoryGel Enhance Single Use Gel Sizer Ultra High ProfileMENTOR TEXAS L.P.MRD2025-04-01
10081317032691MENTOR MemoryGel Enhance Single Use Gel Sizer Ultra High ProfileMENTOR TEXAS L.P.MRD2025-04-01
10081317032707MENTOR MemoryGel Enhance Single Use Gel Sizer Ultra High ProfileMENTOR TEXAS L.P.MRD2025-04-01
10081317032714MENTOR MemoryGel Enhance Single Use Gel Sizer Ultra High ProfileMENTOR TEXAS L.P.MRD2025-04-01
10081317032721MENTOR MemoryGel Enhance Single Use Gel Sizer Ultra High ProfileMENTOR TEXAS L.P.MRD2025-04-01
10081317032738MENTOR MemoryGel Enhance Single Use Gel Sizer Ultra High ProfileMENTOR TEXAS L.P.MRD2025-04-01
00810076890319SIENTRA Silicone Gel Breast Implant SizerSientra, Inc.MRD2023-08-14
00810076890326SIENTRA Silicone Gel Breast Implant SizerSientra, Inc.MRD2023-08-14
00810076890333SIENTRA Silicone Gel Breast Implant SizerSientra, Inc.MRD2023-08-14
00810076890340SIENTRA Silicone Gel Breast Implant SizerSientra, Inc.MRD2023-08-14
00810076890357SIENTRA Silicone Gel Breast Implant SizerSientra, Inc.MRD2023-08-14
00810076890364SIENTRA Silicone Gel Breast Implant SizerSientra, Inc.MRD2023-08-14
00810076890371SIENTRA Silicone Gel Breast Implant SizerSientra, Inc.MRD2023-08-14
00810076890388SIENTRA Silicone Gel Breast Implant SizerSientra, Inc.MRD2023-08-14
00810076890395SIENTRA Silicone Gel Breast Implant SizerSientra, Inc.MRD2023-08-14
00810076890401SIENTRA Silicone Gel Breast Implant SizerSientra, Inc.MRD2023-08-14
00810076890418SIENTRA Silicone Gel Breast Implant SizerSientra, Inc.MRD2023-08-14
00810076890425SIENTRA Silicone Gel Breast Implant SizerSientra, Inc.MRD2023-08-14
00810076890432SIENTRA Silicone Gel Breast Implant SizerSientra, Inc.MRD2023-08-14
00810076890449SIENTRA Silicone Gel Breast Implant SizerSientra, Inc.MRD2023-08-14
00810076890456SIENTRA Silicone Gel Breast Implant SizerSientra, Inc.MRD2023-08-14
00810076890463SIENTRA Silicone Gel Breast Implant SizerSientra, Inc.MRD2023-08-14
00810076890470SIENTRA Silicone Gel Breast Implant SizerSientra, Inc.MRD2023-08-14
00810076890487SIENTRA Silicone Gel Breast Implant SizerSientra, Inc.MRD2023-08-14