FDA.reportPublic FDA data

Natrelle Inspira Cohesive Breast Implants

Primary DI
10888628031258
Brand
Natrelle Inspira Cohesive Breast Implants
Company
Allergan, Inc.
Model
TCX-285
Catalog number
TCX-285
Device description
Natrelle Inspira TCX 285cc Extra full profile BIOCELL textured round silicone
Published
2016-10-04
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FTRProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTRProsthesis, Breast, Noninflatable, Internal, Silicone Gel-FilledGeneral, Plastic Surgery3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P020056034

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P020056034NATRELLE SILICONE-FILLED BREAST IMPLANTSAllergan2006-11-17FTR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888628031258PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088862803125810888628031258

GMDN Terms#

Term, Definition table
TermDefinition
Silicone gel-filled breast implantA sterile implantable device designed to reconstruct or augment the breast that is composed of a silicone rubber shell, made of polysiloxane(s), with a single lumen filled with a fixed amount of silicone gel. The implant may vary in shape, profile, volume, shell surface, and shell thickness.

Device Sizes#

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

Sterilization Methods#

Method table
Method

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
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
07445161001702Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001719Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001726Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001733Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001740Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001757Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001764Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001849Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001856Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001863Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001870Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001887Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001894Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001900Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001917Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001924Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001931Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001948Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001955Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001962Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001979Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161002051Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161002068Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161002075Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161002082Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161002099Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161002105Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161002112Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161002129Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161002136Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04