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Puregraft Serene Breast Implant

FDA UDI

Class III (US FDA UDI)

by Bimini Technologies LLC

Identity

Trade Name
Puregraft Serene Breast Implant FDA UDI
Generic Name
Saline-filled breast implant, internally-structured FDA UDI
Device Name
Saline Breast Implant FDA UDI
Model / Reference
440CC FDA UDI
Description
Saline Breast Implant FDA UDI

Identifiers

Primary DI / UDI-DI
00850034511689 FDA UDI
PMA Number
P120011 FDA UDI
FDA Product Code
FWM FDA UDI
GMDN Term
Saline-filled breast implant, internally-structured 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

Yes

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

Dimensions & Sizes

Size
Total Volume — 440 Milliliter FDA UDI

Category: Saline-filled breast implant, internally-structured

Puregraft Serene Breast Implant by Bimini Technologies LLC — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Saline-filled breast implant, internally-structured.

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
Bimini Technologies LLC

Sources (1)

  • FDA UDI 71835ab4-7b96-4fed-b6fc-bff7a8304b94 35 fields · synced May 30, 2026