Cui Mammary Prothesis Sizer

• • Terminated Z-0702-2020 FDA Class III ·initiated 6 Nov 2019

  The firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-1 configured scanners. These 2D barcodes contain a group separators between fixed-length element string in the UDI data chain of the 2D barcode, which is not formatted to the GS1 standard.

• • Terminated Z-1988-2015 FDA Class II ·initiated 8 Jun 2015

  Allergan is recalling the NATRELLE 410cc Re-Sterilizable Breast Implant Sizer because the expired product was shipped to the user level.

510(k) Number

K831566 ↗

FDA Product Code

MRD

Device Class

U

Advisory Committee

Unknown

FDA Decision

SESE Substantially Equivalent

• Breast Prosthesis (Non & Inflatable) Skin Expander

  Unclassified

  FDA 510(k) K865033 Active Cleared 12 Jan 1987

• Cos-Uphoff Int'l Ds-5 Drainage System

  Class I

  FDA 510(k) K802214 Active Cleared 23 Oct 1980

• Cui Nasal Septum Button

  Unclassified

  FDA 510(k) K871200 Active Cleared 15 Apr 1987

• Ds-7 Closed Wound Suction Drain System

  Class II

  FDA 510(k) K813394 Active Cleared 22 Jan 1982

• Cui Rhinoplasty Implants

  Class II

  FDA 510(k) K853945 Active Cleared 18 Oct 1985

• Cui, Versafil(Tm), Ste(Tm) Tissue Expander

  Class I

  FDA 510(k) K874276 Active Cleared 2 Dec 1987

See all devices from Cox-Uphuff Intl. →