← Back to catalogue

Bodicool Wave Triangle

FDA UDI

Class I (US FDA UDI)

by Trulife Limited

Identity

Trade Name
Bodicool Wave Triangle FDA UDI
Generic Name
External breast prosthesis FDA UDI
Device Name
Bodicool Wave Triangle Cover Size 14 FDA UDI
Model / Reference
C495 14 FDA UDI
Description
Bodicool Wave Triangle Cover Size 14 FDA UDI

Identifiers

Primary DI / UDI-DI
00643293024430 FDA UDI
FDA Product Code
NOJ FDA UDI
GMDN Term
External breast prosthesis FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.3800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: External breast prosthesis

Bodicool Wave Triangle by Trulife Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as External breast prosthesis.

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
Trulife Limited

Sources (1)

  • FDA UDI 8f23e8bb-715d-49dd-b2c7-26760f31561c 33 fields · synced Jun 8, 2026