FDA.reportPublic FDA data

NATRELLE INSPIRA Single Use Sizers

Primary DI
10888628045033
Brand
NATRELLE INSPIRA Single Use Sizers
Company
Allergan, Inc.
Model
SSZ-F295
Catalog number
SSZ-F295
Device description
Natrelle Inspira FullProf 295cc SSZ US
Published
2022-01-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MRDSizer, Mammary, Breast Implant Volume

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRDMammary SizerUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203229000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203229000NATRELLE INSPIRA Single Use Sizers for Gel ImplantsAllergan2021-06-02MRD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888628045033PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088862804503310888628045033

Device Sizes#

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

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10888628044746JUVEDERM ULTRA96206962062019-04-22
00888628047474XEN Glaucoma Treatment System5513-0015513-0012026-07-17
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

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