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ABC Diamond Attach 10487-02-BH

by American Breast Care LP

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 27 Oct 2026. What this means

Regulatory status

as of registry sync 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810008657904 UDI-DI Date9 Oct 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
ABC Diamond Attach
Generic Name
External breast prosthesis
Model / Reference
10487-02-BH
Primary DI / UDI-DI
00810008657904
FDA Product Code
KCZ
GMDN Term
External breast prosthesis
Device Class
Class I
Regulation Number
878.3800
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 145 Milliliter

Overview

AI-generated summary, 27 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The ABC Diamond Attach 10487-02-BH is a Prosthesis, Breast, External, Used With Adhesive, also known as an External breast prosthesis. It is an external device intended to replace the female breast typically after a mastectomy. The device is made of various materials to simulate the appearance and texture of a breast and is typically fitted into a brassiere. The device has a version or model number of 10487-02-BH and comes in a size of 145 Milliliter Total Volume.

The device has a Class I classification and is subject to regulation number 878.3800. It has a product code of KCZ. The device is in commercial distribution and is available over-the-counter.

Other devices from American Breast Care LP

See all devices from American Breast Care LP →

Questions

AI-generated answers, 27 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the ABC Diamond Attach 10487-02-BH?

    It is recorded under the device type "External breast prosthesis". An external device intended to replace the female breast typically after a mastectomy. It is made of various materials to simulate the appearance and texture of a breast and is typically fitted into a brassiere. FDA lists it under the product name "Prosthesis, Breast, External, Used With Adhesive". It is recorded as Class I.

  • What are the product code and regulation of the ABC Diamond Attach 10487-02-BH?

    FDA records the ABC Diamond Attach 10487-02-BH under product code KCZ and regulation number 878.3800.

  • Who makes the ABC Diamond Attach 10487-02-BH?

    AMERICAN BREAST CARE LP is the manufacturer on record for the ABC Diamond Attach 10487-02-BH.

Properties

  • Prescription Use
  • Over-the-Counter
  • Premarket Exempt
  • Serial Number

Other properties (10)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No