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Ideal Implant

FDA UDI

Class III (US FDA UDI)

by Ideal Implant Incorporated

Identity

Trade Name
IDEAL IMPLANT FDA UDI
Generic Name
Saline-filled breast implant, unstructured FDA UDI
Device Name
Round, smooth-surface, saline-filled breast implant. FDA UDI
Model / Reference
67501 FDA UDI
Description
Round, smooth-surface, saline-filled breast implant. FDA UDI

Identifiers

Catalog Number
675 FDA UDI
Primary DI / UDI-DI
10851795006138 FDA UDI
PMA Number
P120011 FDA UDI
FDA Product Code
FWM FDA UDI
GMDN Term
Saline-filled breast implant, unstructured FDA UDI

Classification

Device Class
Class III FDA UDI
Regulation Number
878.3530 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Saline-filled breast implant, unstructured

Ideal Implant by Ideal Implant Incorporated — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Saline-filled breast implant, unstructured.

Cleared under the same submission

P120011 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ideal Implant Incorporated

Sources (1)

  • FDA UDI ac011a68-fa10-41d0-8226-5ca861614b34 37 fields · synced May 29, 2026