FDA.reportPublic FDA data

IDEAL IMPLANT

Primary DI
10851795006107
Brand
IDEAL IMPLANT
Company
IDEAL IMPLANT INCORPORATED
Model
55501
Catalog number
555
Device description
Round, smooth-surface, saline-filled breast implant.
Published
2015-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FWMProsthesis, Breast, Inflatable, Internal, Saline

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FWMProsthesis, Breast, Inflatable, Internal, SalineGeneral, Plastic Surgery3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P120011000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P120011000Puregraft Serene Breast ImplantBimini Health Tech2014-11-14FWM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10851795006107PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085179500610710851795006107

GMDN Terms#

Term, Definition table
TermDefinition
Saline-filled breast implant, unstructuredA sterile implantable device designed to reconstruct or augment the breast that is composed of a silicone rubber outer shell, made of polysiloxane(s), with a single lumen inflated with sterile isotonic saline to the desired size. The implant may be of fixed or adjustable volume and may be prefilled, partially filled, or empty and filled during the implantation procedure; the volume of saline solution in adjustable volume implants may be adjusted after implantation. The device may vary in shape, profile, volume, shell surface, and shell thickness.

Device Sizes#

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

Contacts#

Phone, Email table
PhoneEmail
214-492-2500info@idealimplant.com

Regulatory Flags#

DUNS number
005225418
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10851795006008IDEAL IMPLANT 210012102015-09-09
10851795006015IDEAL IMPLANT240012402015-09-09
10851795006022IDEAL IMPLANT270012702015-09-09
10851795006039IDEAL IMPLANT300013002015-09-09
10851795006046IDEAL IMPLANT335013352015-09-09
10851795006053IDEAL IMPLANT370013702015-09-09
10851795006060IDEAL IMPLANT405014052015-09-09
10851795006077IDEAL IMPLANT440014402015-09-09
10851795006084IDEAL IMPLANT475014752015-09-09
10851795006091IDEAL IMPLANT515015152015-09-09
10851795006114IDEAL IMPLANT595015952015-09-09
10851795006121IDEAL IMPLANT635016352015-09-09
10851795006138IDEAL IMPLANT675016752015-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10081317028670MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028687MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028694MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028700MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028717MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028724MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028731MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028748MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028755MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028762MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028779MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028786MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028793MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028809MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028816MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028823MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028830MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028847MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028854MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028861MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028939MENTOR Smooth Round High ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028946MENTOR Smooth Round Moderate ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028953MENTOR Smooth Round High ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028960MENTOR Smooth Round High ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028977MENTOR Smooth Round Moderate ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028984MENTOR Smooth Round Moderate ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028991MENTOR Smooth Round Moderate ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317029004MENTOR Smooth Round Moderate ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317029011MENTOR Smooth Round Moderate ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317029028MENTOR Smooth Round Moderate ProfileMENTOR TEXAS L.P.FWM2025-03-17