NATRELLE Resterilizable Breast Implant Sizers

Primary DI
10888628006232
Brand
NATRELLE Resterilizable Breast Implant Sizers
Company
Allergan, Inc.
Model
MSZ45550
Catalog number
MSZ45550
Device description
NATRELLE Gel Rstrl Sizer Mod Sty 45-550
Published
2022-10-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
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
K831566000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K831566000CUI MAMMARY PROTHESIS SIZERCox-Uphuff Intl.1983-08-12MRD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888628006232PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088862800623210888628006232

GMDN Terms#

Term, Definition table
TermDefinition
Invasive breast implant sizer, fixed, single-useA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
8006244261ProductSupport@allergan.com

Regulatory Flags#

DUNS number
144796497
Device count
1
Serial number
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10888628031432Natrelle Inspira ST Resterilizable SizersMSZST-L110MSZST-L1102016-10-04
10888628031449Natrelle Inspira ST Resterilizable SizersMSZST-L125MSZST-L1252016-10-04
10888628031456Natrelle Inspira ST Resterilizable SizersMSZST-L140MSZST-L1402016-10-04
10888628031463Natrelle Inspira ST Resterilizable SizersMSZST-L170MSZST-L1702016-10-04
10888628031470Natrelle Inspira ST Resterilizable SizersMSZST-L200MSZST-L2002016-10-04
10888628031487Natrelle Inspira ST Resterilizable SizersMSZST-L230MSZST-L2302016-10-04
10888628031494Natrelle Inspira ST Resterilizable SizersMSZST-L260MSZST-L2602016-10-04
10888628031500Natrelle Inspira ST Resterilizable SizersMSZST-L290MSZST-L2902016-10-04
10888628031517Natrelle Inspira ST Resterilizable SizersMSZST-L320MSZST-L3202016-10-04
10888628031524Natrelle Inspira ST Resterilizable SizersMSZST-L350MSZST-L3502016-10-04
10888628031531Natrelle Inspira ST Resterilizable SizersMSZST-L380MSZST-L3802016-10-05
10888628031548Natrelle Inspira ST Resterilizable SizersMSZST-L410MSZST-L4102016-10-05
10888628031555Natrelle Inspira ST Resterilizable SizersMSZST-L460MSZST-L4602016-10-05
10888628031562Natrelle Inspira ST Resterilizable SizersMSZST-L510MSZST-L5102016-10-05
10888628031579Natrelle Inspira ST Resterilizable SizersMSZST-L560MSZST-L5602016-10-05
10888628031586Natrelle Inspira ST Resterilizable SizersMSZST-L610MSZST-L6102017-03-20
10888628031593Natrelle Inspira ST Resterilizable SizersMSZST-LP125MSZST-LP1252016-10-05
10888628031609Natrelle Inspira ST Resterilizable SizersMSZST-LP145MSZST-LP1452016-10-05
10888628031616Natrelle Inspira ST Resterilizable SizersMSZST-LP165MSZST-LP1652016-10-05
10888628031623Natrelle Inspira ST Resterilizable SizersMSZST-LP190MSZST-LP1902016-10-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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00810076890340SIENTRA Silicone Gel Breast Implant SizerSientra, Inc.MRD2023-08-14
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00810076890371SIENTRA Silicone Gel Breast Implant SizerSientra, Inc.MRD2023-08-14
00810076890388SIENTRA Silicone Gel Breast Implant SizerSientra, Inc.MRD2023-08-14
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00810076890470SIENTRA Silicone Gel Breast Implant SizerSientra, Inc.MRD2023-08-14
00810076890487SIENTRA Silicone Gel Breast Implant SizerSientra, Inc.MRD2023-08-14