FDA.report

Natrelle 410 Resterilizable Sizers

Primary DI
10888628004641
Brand
Natrelle 410 Resterilizable Sizers
Company
Allergan, Inc.
Model
MSZFF160
Catalog number
MSZFF160
Device description
NATRELLE 410 Rester Szr Sty MSZ-FF160
Published
2015-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
MRDSizer, Mammary, Breast Implant Volume

Product Code Classifications

CodeDeviceSpecialtyClass
MRDMammary SizerUnknownU

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10888628004641PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1088862800464110888628004641

GMDN Terms

TermDefinition
Invasive breast implant sizer, single-useA sterile surgical instrument 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. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method
Dry Heat Sterilization

Contacts

PhoneEmail
8006244261ProductSupport@allergan.com

Regulatory Flags

DUNS number
144796497
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
30840228302767SKINVIVE BY JUVEDERM XC 1ML SAMPLE98307DB98307DB2024-04-10
30840228302774JUVEDERM ULTRA PLUS XC 1ML SAMPLE94155DB94155DB2024-04-10
30840228302781JUVEDERM ULTRA XC 1ML SAMPLE94154DB94154DB2024-04-10
30840228302798JUVEDERM VOLBELLA XC 1ML SAMPLE96181DB96181DB2024-04-10
30840228302804JUVEDERM VOLBELLA XC 0.55ML SAMPLE96183DB96183DB2024-04-10
30840228302811JUVEDERM VOLLURE XC 1ML SAMPLE95661DB95661DB2024-04-10
30840228302828JUVEDERM VOLUMA XC 1ML SAMPLE94640DB94640DB2024-04-10
30840228302835JUVEDERM VOLUX XC 1ML SAMPLE20074128200741282024-04-10
30840228300060Skinvive98307983072023-05-22
10888628005907NATRELLE Resterilizable Breast Implant SizersMSZ20120MSZ201202022-10-23
10888628005914NATRELLE Resterilizable Breast Implant SizersMSZ20140MSZ201402022-10-23
10888628005921NATRELLE Resterilizable Breast Implant SizersMSZ20160MSZ201602022-10-23
10888628005938NATRELLE Resterilizable Breast Implant SizersMSZ20180MSZ201802022-10-23
10888628005945NATRELLE Resterilizable Breast Implant SizersMSZ20200MSZ202002022-10-23
10888628005952NATRELLE Resterilizable Breast Implant SizersMSZ20230MSZ202302022-10-23
10888628005969NATRELLE Resterilizable Breast Implant SizersMSZ20260MSZ202602022-10-23
10888628005976NATRELLE Resterilizable Breast Implant SizersMSZ20280MSZ202802022-10-23
10888628005983NATRELLE Resterilizable Breast Implant SizersMSZ20300MSZ203002022-10-23
10888628005990NATRELLE Resterilizable Breast Implant SizersMSZ20325MSZ203252022-10-23
10888628006003NATRELLE Resterilizable Breast Implant SizersMSZ20350MSZ203502022-10-23

Other Devices Sharing Product Codes

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