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Bodicool Triangle

FDA UDI

Class I (US FDA UDI)

by Trulife, Inc.

Identity

Trade Name
Bodicool Triangle FDA UDI
Generic Name
External breast prosthesis FDA UDI
Device Name
Bodicool Triangle Cover Size 6 FDA UDI
Model / Reference
C490 06 FDA UDI
Description
Bodicool Triangle Cover Size 6 FDA UDI

Identifiers

Primary DI / UDI-DI
00643293022764 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 Triangle by Trulife, Inc. — 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

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Manufacturer

Manufacturer
Trulife, Inc.

Sources (1)

  • FDA UDI 1dfbb5ed-550d-41f1-a835-7dad6ec1c029 33 fields · synced Jun 4, 2026