← Back to catalogue

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
595CC FDA UDI
Description
Saline Breast Implant FDA UDI

Identifiers

Primary DI / UDI-DI
00850034511856 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 — 595 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Bimini Technologies LLC

Sources (1)

  • FDA UDI 99ae88c7-6c8b-425f-971b-3ce4ff67f76a 35 fields · synced May 30, 2026