Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Sterile Disposable Endocavity Needle Guide for use with Esaote EC123, EC1123, SE3123, SE3133, TRT12 & IVT12, GE Healthcare IC5-9-RS & IC5-9W-RS, Philips E6509, Siemens BE9-4, Samsung Medison BCC4-9, Pie Medical C7-4R8TRD and Terason 8EC4 Ultrasound Transducers
PROTEK MEDICAL PRODUCTS, INC.
5565
In Commercial Distribution

  • 10841912106612 ()
  • 00841912106615 ()
5565

  • Needle guide, single-use
Disposable Needle Guides Kit for endocavity biopsy, contents: Needle guide use with Canon PVF-641VT, PVM-651VT, PVN-661VT, PVQ-641V, PVT-661VT; Siemens cEC9-4(ACUSON S1000, S2000, S3000 and SONOLINE Antares) ultrasound transducers; 20g gel; 5x30cm latex cover, rubber bands.
JingFang Precision Medical Device(Shenzhen) Co., Ltd.
DEK-008
In Commercial Distribution

  • 16971554726382 ()
  • 06971554726385 ()
10638

  • Needle guide, single-use
Disposable Needle Guides Kit for endocavity biopsy, contents: Needle guide use with Samsung EA2-11B; Siemens EC9-4, EV9-4(ACUSON X150, X300, P500, OMNI, NX2, NX3; SONOLINE G40); Terason 8EC4A ultrasound transducers; 20g gel; 5x30cm latex cover, rubber bands.
JingFang Precision Medical Device(Shenzhen) Co., Ltd.
DEK-021
In Commercial Distribution

  • 06971554726514 ()
10651

  • Needle guide, single-use
Disposable Needle Guides Kit for endocavity biopsy, contents: Needle guide use with SuperSonic SE12-3; Siemens EC-10C5, EC9-4(ACUSON X500; SONOLINE G20, G50, G60S), EV9-4(ACUSON X500); ECM E610A ultrasound transducers; 20g gel; 5x30cm latex cover, rubber bands.
JingFang Precision Medical Device(Shenzhen) Co., Ltd.
DEK-020
In Commercial Distribution

  • 16971554726504 ()
  • 06971554726507 ()
10650

  • Needle guide, single-use
Sterile Disposable Endocavity Needle Guide for use with Siemens EC9-4 (Acuson NX2™, NX3™, NX3™ Elite, P500™, X150™, X300™ & Sonoline G40™ Ultrasound Systems), EV9-4 (Sonoline G40™ & Acuson X150™ & X300™ Ultrasound Systems) Ultrasound Transducers
PROTEK MEDICAL PRODUCTS, INC.
5480
In Commercial Distribution

  • 10841912105745 ()
  • 00841912105748 ()
5480

  • Needle guide, single-use
Sterile endocavity needle guide for use with Siemens EC9-4 and EV9-4 (on G40, Acuson X150, X300) and Samsung Medison EA2-11B transducers. One-cell MEA: =80% embryo developed to expand cytoblast at 96 hours USP Endotoxin (LAL) tested and passed with 20 EU or less per device.
CIVCO MEDICAL INSTRUMENTS CO., INC.
876-001
In Commercial Distribution

  • 00841436122351 ()
  • 10841436122358 ()
  • 00841436123112 ()
876-001, 867-001-5

  • Needle guide, single-use
Sterile endocavity needle guide for use with Siemens EC9-4 (on Sonoline Antares and S2000); Canon Medical Systems PVF-651VT, PVM-651VT, PVN-661VT, PVQ-641V, PVT-661VT transducers One-cell MEA: =80% embryo developed to expand cytoblast at 96 hours USP Endotoxin (LAL) tested and passed with 20 EU or less per device.
CIVCO MEDICAL INSTRUMENTS CO., INC.
810-400
In Commercial Distribution

  • 00841436123228 ()
  • 10841436123225 ()
  • 00841436123235 ()
810-400, 810-400-5

  • Needle guide, single-use
Sterile endocavity needle guide for use with International Biomedical E717 6.5 MHz, Mindray 65EB10EA, 6CV1, 6CV1s, EV6.5Mhz/R10, V10-4, V10-4s, V11-3s, V11-3Ws, Samsung Medison EC4-9ES, EC4-9IS, ER4-9ES, Siemens 6.5EC10, SuperSonic E12-3, SE12-3, SEV12-3 transducers One-cell MEA: =80% embryo developed to expand cytoblast at 96 hours USP Endotoxin (LAL) tested and passed with 20 EU or less per device.
CIVCO MEDICAL INSTRUMENTS CO., INC.
810-401
In Commercial Distribution

  • 00841436123259 ()
  • 10841436123249 ()
  • 00841436123242 ()
810-401, 810-401-5

  • Needle guide, single-use
Sterile Disposable Endocavity Needle Guide Kit for use with: Chison D7C10L & V7-E, Esaote E8-5 R10, International Biomedical E717, Kretz PB-ER4-9ES, Mindray EV6.5 MHZ/R10, 6CV1, 6CV1s, 65EC10EA, 65EC10EB, 65EC10HA, CB10-4, CB10-HS, V10-4, V10-4B, V10-4BS, V10-4S, V11-3E, V11-3WE & V11-3WS,Samsung Medison EC4-9IS, EC4-9ES, ER4-9ES, & 10R EV/140D, Siemens 6.5 EC10, EC7, EC9-4 (Sonoline G20, G50S & Acuson X500 Ultrasound Systems), & EV9-4 (Acuson X500 Ultrasound System), Supersonic Imagine SuperEndocavity SE12-3 & SEV12-3, Terason 8EC4(V), Vermon E710, and Zonare E9-3
PROTEK MEDICAL PRODUCTS, INC.
9005
In Commercial Distribution

  • 10841912105264 ()
  • 00841912105267 ()
9005

  • Body-orifice ultrasound imaging transducer cover, basic
  • Needle guide, single-use
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