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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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AUTOMATIC GUILLOTINE NEEDLE FOR SOFT-TISSUE BIOPSY
BIOPSYBELL SRL
ESTER ONE SHOT
In Commercial Distribution

  • 08033860016319 ()

  • Length: 150 Millimeter
  • Needle Gauge: 16 Gauge
GUN1615EC-OS

  • End-cut biopsy gun handpiece/needle
Automatic guillotine needle for soft tissue biopsy
BIOPSYBELL SRL
Ester one shot
In Commercial Distribution

  • 08033860016302 ()
  • 08033860016296 ()

  • Length: 150 Millimeter
  • Needle Gauge: 14 Gauge
GUN1415EC-OS

  • End-cut biopsy gun handpiece/needle
Unlocker for use with the CarboClear Pedicle Screw System.
CARBOFIX ORTHOPEDICS LTD
Unlocker - One Piece
In Commercial Distribution

  • 07290110204648 ()
PPS922781

  • Orthopaedic inorganic implant inserter/extractor, reusable
OTC Rechargeable Hearing Aid
Audicon Corporation
Core One Pro
In Commercial Distribution

  • 10850065321308 ()
  • 00850065321301 ()
CE-A90A(White)

  • Air-conduction hearing aid, in-the-ear
OTC Rechargeable Hearing Aid
Audicon Corporation
Core One Pro
In Commercial Distribution

  • 10850065321292 ()
  • 00850065321295 ()
CE-A90A(Black)

  • Air-conduction hearing aid, in-the-ear
OTC Rechargeable Hearing Aid
Audicon Corporation
Core One Pro
In Commercial Distribution

  • 10850065321261 ()
  • 00850065321264 ()
CE-A90A(skin)

  • Air-conduction hearing aid, in-the-ear
Rotational Excisional Atherectomy System. The Catheter Set includes one Rotarex™S catheter (gauge 6F; length 135 cm), one guidewire (0.018” diameter; 320 cm in length), one sterile and one collecting bag.
Straub Medical AG
80237
In Commercial Distribution

  • 07640142811862 ()

  • Catheter Gauge: 6 French
  • Catheter Working Length: 135 Centimeter
80237

  • Mechanical atherectomy system catheter/handpiece
Rotational Excisional Atherectomy System. The Catheter Set includes one Rotarex®S catheter (gauge 6F; length 135 cm), one guidewire (0.018” diameter; 320 cm in length), one drape and one collecting bag.
Straub Medical AG
Version 1.0
Not in Commercial Distribution

  • 07640142810582 ()

  • Catheter Working Length: 135 Centimeter
  • Catheter Gauge: 6 French
80237

  • Mechanical atherectomy system catheter/handpiece
VS BRST 1.5T 8CH TT FUL SET w ESPREE RSR consists of one patient support assembly, one medial coil element, one interface box, 1Ch left and right coil elements, one medial plug, 3Ch left and right coil elements, one fiducial marker block assembly, and one box of 10 sterilized biopsy grids.
Philips Medical Systems Nederland B.V.
989603217331
In Commercial Distribution

  • 00884838120051 ()


  • MRI system coil, radio-frequency
VS BRST 1.5T 8CH TT FUL SET w SHALOW RSR consists of one patient support assembly, one medial coil element, one interface box, 1Ch left and right coil elements, one medial plug, 3Ch left and right coil elements, one fiducial marker block assembly and one box of 10 sterilized biopsy grids.
Philips Medical Systems Nederland B.V.
989603217341
In Commercial Distribution

  • 00884838120020 ()


  • MRI system coil, radio-frequency
VS BREAST 1.5T 16CH TT FULL SET consists of one patient support assembly, one fiducial marker block assembly, one box of 10 sterilized biopsy grids, 4Ch left and right coil elements, one 8Ch medial coil element, one 16Ch interface box, 1Ch left and right coil elements, and one medial plug.
Philips Medical Systems Nederland B.V.
989603217571
In Commercial Distribution

  • 00884838119895 ()


  • MRI system coil, radio-frequency
Plaster spreader for one hand, 9"
BR Surgical, LLC
WG30-36623
In Commercial Distribution

  • 00840183517687 ()
WG30-36623

  • Cast spreader, reusable
TAUT SYSTEM ONE TRIFECTA BALLOON 5FRX75
TELEFLEX INCORPORATED
IPN007865
In Commercial Distribution

  • 24026704418910 ()

  • Length: 86.5 Centimeter
50640

  • Laparoscopic access cannula, single-use
Nyström, one pair, I and II
E. Hahnenkratt GmbH
20
In Commercial Distribution

  • E206200 ()


  • Dental matrix band tensioner
BIO | One Stage Implant Driver Long
BLUE SKY BIO LLC
DT0018
In Commercial Distribution

  • 00810060221419 ()


  • Surgical torque wrench adaptor
BIO | One Stage Implant Driver Short
BLUE SKY BIO LLC
DT0014
In Commercial Distribution

  • 00810060221402 ()


  • Surgical torque wrench adaptor
BIO | One Stage Digital Scan Body
BLUE SKY BIO LLC
MOD5500
In Commercial Distribution

  • 00810060224939 ()


  • Dental implant analog
Trinity Kit WHITE ALL IN ONE
Nuface
42083
In Commercial Distribution

  • 00810075940244 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
  • Red-light phototherapy unit, battery-powered
ONE PIECE THUMB STEM RASP 10.0MM
BIOPRO, INC.
22862
In Commercial Distribution

  • M20922862 ()


  • Surgical implant/trial-implant/sizer holder, reusable
ONE PIECE THUMB STEM RASP 8.5MM
BIOPRO, INC.
22861
In Commercial Distribution

  • M20922861 ()


  • Surgical implant/trial-implant/sizer holder, reusable
ONE PIECE THUMB STEM RASP 7.5MM
BIOPRO, INC.
22860
In Commercial Distribution

  • M20922860 ()


  • Surgical implant/trial-implant/sizer holder, reusable
Leg section one part H V
Baxter Medical Systems GmbH + Co. KG
1850959
In Commercial Distribution

  • 00887761970366 ()


  • Operating table orthopaedic extension, non-powered
Pad leg section one part short
Baxter Medical Systems GmbH + Co. KG
1570940
Not in Commercial Distribution

  • 00887761969919 ()


  • Operating table patient pressure distribution pad, reusable
Pad leg section one part light
Baxter Medical Systems GmbH + Co. KG
1611308
Not in Commercial Distribution

  • 00887761969841 ()


  • Operating table patient pressure distribution pad, reusable
Pad TTS Carbon one part B
Baxter Medical Systems GmbH + Co. KG
1873466
Not in Commercial Distribution

  • 00887761969421 ()


  • Operating table mattress, basic
Pad TTS Carbon one part G
Baxter Medical Systems GmbH + Co. KG
2080466
In Commercial Distribution

  • 00887761968899 ()


  • Operating table orthopaedic extension, non-powered
Leg section one part M EU
Baxter Medical Systems GmbH + Co. KG
2066984
Not in Commercial Distribution

  • 00887761967786 ()


  • Operating table orthopaedic extension, non-powered
Arm support device one hand operation
Baxter Medical Systems GmbH + Co. KG
4549528
In Commercial Distribution

  • 00887761973404 ()


  • Operating table orthopaedic extension, non-powered
4Chamber Center-body extension zipper (one size)
DAESUNG MAREF CO.,LTD.
ACg0433
Not in Commercial Distribution

  • 38809315677982 ()
  • 08809315677974 ()


  • Pneumatic massager
SERRATED SAW One Sided w/6.0mm
M.D.T. - MICRO DIAMOND TECHNOLOGIES LTD.
SBS-000-N5
In Commercial Distribution

  • 07291046700839 ()
SBS-000

  • Dental abrasive strip, reusable
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