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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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Vitale Silicone Foam Dressings, 3" X 3", 10/box, 10 boxes/case
CELLERA LLC
20133
Not in Commercial Distribution

  • B492201332 ()
  • B492201331 ()
  • B492201330 ()
20133

  • Exudate-absorbent dressing, non-gel, non-antimicrobial
The VASCADE VCS is intended to seal femoral vessel puncture sites at the completion of catheter-based procedures. The system is designed to deliver a resorbable Collagen Patch, extra-vascularly, at the vessel puncture site to achieve hemostasis. For use in 6F & 7F introducer sheaths; overall length of the sheath (including the hub) needs to be less than 15cm.
CARDIVA MEDICAL, INC.
700-580I
In Commercial Distribution

  • M729700580I1 ()
  • M729700580I0 ()
  • M729700580I3 ()

  • Catheter Gauge: 7 French
  • Catheter Gauge: 6 French


  • Femoral artery closure plug/patch, collagen
The VASCADE VCS is intended to seal femoral vessel puncture sites at the completion of catheter-based procedures. The system is designed to deliver a resorbable Collagen Patch, extra-vascularly, at the vessel puncture site to achieve hemostasis. For use in 5F introducer sheaths; overall length of the sheath (including the hub) needs to be less than 15cm.
CARDIVA MEDICAL, INC.
700-500DX
In Commercial Distribution

  • M729700500DX1 ()
  • M729700500DX0 ()
  • M729700500DX3 ()

  • Catheter Gauge: 5 French


  • Femoral artery closure plug/patch, collagen
INTRODUCER,KIT 4FR X 11CM WITH .018X45CM SS/SS WIRE 21GX7CM NEEDLE
STRADIS MEDICAL, LLC
525-079
Not in Commercial Distribution

  • M7525250791 ()
  • M7525250793 ()
  • M7525250792 ()

  • Catheter Gauge: 4 French
  • Needle Gauge: 21 Gauge
  • Length: 11 Centimeter
525-079

  • Vascular catheter introduction set, nonimplantable
5FR Micro-Introducer Kit
STRADIS MEDICAL, LLC
525-038 R1
Not in Commercial Distribution

  • M752525038R10 ()
  • M752525038R13 ()
  • M752525038R15 ()


  • Vascular catheter introduction set, nonimplantable
MRI ECG Electrode 110mm x 110mm
MIPM Mammendorfer Institut für Physik und Medizin GmbH
large
In Commercial Distribution

  • EMIP53002030 ()
  • EMIP53002031 ()
  • EMIP53002032 ()
5300203

  • Electrocardiographic electrode, single-use
MRI ECG Electrode 70mm x 70mm
MIPM Mammendorfer Institut für Physik und Medizin GmbH
small
In Commercial Distribution

  • EMIP53002020 ()
  • EMIP53002021 ()
  • EMIP53002022 ()
5300202

  • Electrocardiographic electrode, single-use
NEEDLE,25 X 1
American Health Service Sales Corporation
AHS2525RN
In Commercial Distribution

  • B031AHS2525RN2 ()
  • B031AHS2525RN1 ()
  • B031AHS2525RN0 ()


  • Hypodermic needle, single-use
NEEDLE,22 X 1
American Health Service Sales Corporation
AHS2225RN
In Commercial Distribution

  • B031AHS2225RN2 ()
  • B031AHS2225RN1 ()
  • B031AHS2225RN0 ()


  • Hypodermic needle, single-use
NEEDLE,20 X 1.5
American Health Service Sales Corporation
AHS2038RN
In Commercial Distribution

  • B031AHS2038RN2 ()
  • B031AHS2038RN1 ()
  • B031AHS2038RN0 ()


  • Hypodermic needle, single-use
NEEDLE,20 X 1
American Health Service Sales Corporation
AHS2025RN
In Commercial Distribution

  • B031AHS2025RN2 ()
  • B031AHS2025RN1 ()
  • B031AHS2025RN0 ()


  • Hypodermic needle, single-use
SYRINGE,1CC,29X1/2,U-40,INSULIN
American Health Service Sales Corporation
AH10M291340
In Commercial Distribution

  • B031AH10M2913402 ()
  • B031AH10M2913401 ()
  • B031AH10M2913400 ()


  • Insulin syringe/needle, basic
SYRINGE,1CC 29 X 1/2,U-100 INSULIN
American Health Service Sales Corporation
AH10M2913
In Commercial Distribution

  • B031AH10M29132 ()
  • B031AH10M29131 ()
  • B031AH10M29130 ()


  • Insulin syringe/needle, basic
SYRINGE,1/2CC 29X1/2,U-40,INSULIN
American Health Service Sales Corporation
AH05M291340
In Commercial Distribution

  • B031AH05M2913402 ()
  • B031AH05M2913401 ()
  • B031AH05M2913400 ()


  • Insulin syringe/needle, basic
SYRINGE,1/2CC,29X1/2,U-100 INSULIN
American Health Service Sales Corporation
AH05M2913
In Commercial Distribution

  • B031AH05M29132 ()
  • B031AH05M29131 ()
  • B031AH05M29130 ()


  • Insulin syringe/needle, basic
SYRINGE,3CC 22 X 3/4,LUER SLIP
American Health Service Sales Corporation
AH03S2219
In Commercial Distribution

  • B031AH03S22192 ()
  • B031AH03S22191 ()
  • B031AH03S22190 ()


  • General-purpose syringe, single-use
SYRINGE,3CC,LUER LOCK,27 X 1.5
American Health Service Sales Corporation
AH03L2738
In Commercial Distribution

  • B031AH03L27382 ()
  • B031AH03L27381 ()
  • B031AH03L27380 ()


  • General-purpose syringe, single-use
SYRINGE,3CC,LUER LOCK,25 X 1.5
American Health Service Sales Corporation
AH03L2538
In Commercial Distribution

  • B031AH03L25382 ()
  • B031AH03L25381 ()
  • B031AH03L25380 ()


  • General-purpose syringe, single-use
SYRINGE,3CC,LUER LOCK,25 X 1
American Health Service Sales Corporation
AH03L2525
In Commercial Distribution

  • B031AH03L25252 ()
  • B031AH03L25251 ()
  • B031AH03L25250 ()


  • General-purpose syringe, single-use
SYRINGE,3CC,LUER LOCK,25 X 5/8
American Health Service Sales Corporation
AH03L2516
In Commercial Distribution

  • B031AH03L25162 ()
  • B031AH03L25161 ()
  • B031AH03L25160 ()


  • General-purpose syringe, single-use
SYRINGE,3CC,LUER LOCK,23 X 1
American Health Service Sales Corporation
AH03L2325
In Commercial Distribution

  • B031AH03L23252 ()
  • B031AH03L23251 ()
  • B031AH03L23250 ()


  • General-purpose syringe, single-use
SYRINGE,3CC,LUER LOCK,22 X 1.5
American Health Service Sales Corporation
AH03L2238
In Commercial Distribution

  • B031AH03L22382 ()
  • B031AH03L22381 ()
  • B031AH03L22380 ()


  • General-purpose syringe, single-use
SYRINGE,LUER LOCK,3CC 22 X 1
American Health Service Sales Corporation
AH03L2225
In Commercial Distribution

  • B031AH03L22252 ()
  • B031AH03L22251 ()
  • B031AH03L22250 ()


  • General-purpose syringe, single-use
SYRINGE,LUER LOCK,3CC 22 X 3/4
American Health Service Sales Corporation
AH03L2219
In Commercial Distribution

  • B031AH03L22192 ()
  • B031AH03L22191 ()
  • B031AH03L22190 ()


  • General-purpose syringe, single-use
SYRINGE,3CC,LUER LOCK,21 X 1
American Health Service Sales Corporation
AH03L2125
In Commercial Distribution

  • B031AH03L21252 ()
  • B031AH03L21251 ()
  • B031AH03L21250 ()


  • General-purpose syringe, single-use
SYRINGE,3CC,20 X 1.5,L/L
American Health Service Sales Corporation
AH03L2038
In Commercial Distribution

  • B031AH03L20382 ()
  • B031AH03L20381 ()
  • B031AH03L20380 ()


  • General-purpose syringe, single-use
SYRINGE,3CC 20 X 1,L/L
American Health Service Sales Corporation
AH03L2025
In Commercial Distribution

  • B031AH03L20252 ()
  • B031AH03L20251 ()
  • B031AH03L20250 ()


  • General-purpose syringe, single-use
Monophase Crown Impression Material
Prismatik Dentalcraft, Inc
70-1031-CAP0030
In Commercial Distribution

  • D745701031CAP00171 ()
  • D745701031CAP00300 ()
  • D745701028CAP00121 ()
70-1031-CAP0030

  • Silicone dental impression material
Monophase Bridge Impression Material
Prismatik Dentalcraft, Inc
70-1031-CAP0029
In Commercial Distribution

  • D745701031CAP00181 ()
  • D745701031CAP00290 ()
  • D745701028CAP00091 ()
70-1031-CAP0029

  • Silicone dental impression material
Medium Crown Impression Material
Prismatik Dentalcraft, Inc
70-1031-CAP0028
In Commercial Distribution

  • D745701031CAP00131 ()
  • D745701031CAP00280 ()
  • D745701028CAP00111 ()
70-1031-CAP0028

  • Silicone dental impression material
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