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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The QUATTRO Elite Snares are intended for use in the cardiovascular system and hollow viscus to retrieve and/or manipulate objects using minimally invasive surgical procedures. Manipulation procedures include retrieval and/or repositioning of intravascular foreign objects such as coils, balloons, catheters and/or guidewires within the cardiovascular system.
Vascular Solutions, Inc.
8414
Not in Commercial Distribution

  • M20684140 ()

  • Length: 150 Centimeter
  • 35 mm Snare Loop
  • Outer Diameter: 0.035 Inch


  • Intravascular extraction catheter-snare
The EXPRO Elite Snares are intended for use in the cardiovascular system and hollow viscus to retrieve and/or manipulate objects using minimally invasive surgical procedures. Manipulation procedures include retrieval and/or repositioning of intravascular foreign objects such as coils, balloons, catheters and/or guidewires within the cardiovascular system.
Vascular Solutions, Inc.
8404
Not in Commercial Distribution

  • M20684040 ()

  • Length: 150 Centimeter
  • 35 mm Snare Loop
  • Outer Diameter: 0.035 Inch


  • Intravascular extraction catheter-snare
DIST, LEFORT 3/MONO, BI LEVEL MIDFACE, ADJ, RIGHT, 1.5-1.8 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
51-411-30-09
In Commercial Distribution

  • 00888118098610 ()

  • 30 MM, 35 HOLE


  • Implantable craniofacial bone distractor
DIST, LEFORT 3/MONO, BI LEVEL MIDFACE, ADJ, LEFT, 1.5-1.8 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
51-410-30-09
In Commercial Distribution

  • 00888118098603 ()

  • 30 MM, 35 HOLE


  • Implantable craniofacial bone distractor
DIST, LEFORT 3/MONO, MULTI LEVEL MIDFACE, RIGHT, 1.5-1.8 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
990-6933-02
Not in Commercial Distribution

  • 00888118093332 ()

  • 30 MM, 35 HOLE


  • Implantable craniofacial bone distractor
DIST, LEFORT 3/MONO, MULTI LEVEL MIDFACE, LEFT, 1.5-1.8 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
990-6933-01
Not in Commercial Distribution

  • 00888118093325 ()

  • 30 MM, 35 HOLE


  • Implantable craniofacial bone distractor
DIST, LEFORT 3/MONO, MULTI LEVEL MIDFACE, RIGHT, 1.5-1.8 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
99-069-33-02
Not in Commercial Distribution

  • 00888118095459 ()

  • 30 MM, 35 HOLE


  • Implantable craniofacial bone distractor
DIST, LEFORT 3/MONO, MULTI LEVEL MIDFACE, LEFT, 1.5-1.8 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
99-069-33-01
Not in Commercial Distribution

  • 00888118095442 ()

  • 30 MM, 35 HOLE


  • Implantable craniofacial bone distractor
DIST, LEFORT 3/MONO, BI LEVEL MIDFACE, ADJ, RIGHT, RTCH, 1.5-1.8 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
51-411-30-71
In Commercial Distribution

  • 00888118104670 ()

  • 30 MM, 35 HOLE


  • Implantable craniofacial bone distractor
DIST, LEFORT 3/MONO, BI LEVEL MIDFACE, ADJ, LEFT, RTCH, 1.5-1.8 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
51-410-30-71
In Commercial Distribution

  • 00888118104632 ()

  • 30 MM, 35 HOLE


  • Implantable craniofacial bone distractor
CLIP PENDITURE LAAC35
MEDTRONIC, INC.
LAAC35
In Commercial Distribution

  • 00763000791445 ()

  • Clip size 35 mm


  • Ligation clip, metallic
No Description
Biomet Orthopedics, LLC
CP250312
In Commercial Distribution

  • 00887868246586 ()

  • 5 mm 35 mm
CP250312

  • Orthopaedic bone screw, non-bioabsorbable, sterile
Toxi-Titer Plate, 48 Wells
MARDX DIAGNOSTICS, INC.
B1029-70D
In Commercial Distribution

  • 05391516747998 ()
B1029-70D

  • Clostridium difficile toxin A/B antigen IVD, reagent
FreeStyle Control Solution
ABBOTT DIABETES CARE INC
70432
In Commercial Distribution

  • 20699073704324 ()
  • 00699073704320 ()
70432

  • Glucose monitoring system IVD, home-use
FreeStyle Control Solution
ABBOTT DIABETES CARE INC
14002
In Commercial Distribution

  • 20699073140023 ()
  • 00699073140029 ()
  • 10699073140026 ()
14002

  • Glucose monitoring system IVD, home-use
Coag-Sense PT/INR Patient Self-Test System
COAGUSENSE INC.
200221
In Commercial Distribution

  • 00861900000381 ()
03P70-01

  • Prothrombin time (PT) IVD, kit, rapid clotting, clinical
Coag-Sense PT/INR Professional System
COAGUSENSE INC.
200222
In Commercial Distribution

  • 00861900000374 ()
03P70-02

  • Prothrombin time (PT) IVD, kit, rapid clotting, clinical
Coag-Sense PT/INR Meter
COAGUSENSE INC.
200107
In Commercial Distribution

  • 00861900000350 ()
03P73-01

  • Prothrombin time (PT) IVD, kit, rapid clotting, clinical
Coag-Sense Professional Control Test Strip Kit - 10 Ct
COAGUSENSE INC.
100250
In Commercial Distribution

  • 00861900000343 ()
03P69-10

  • Prothrombin time (PT) IVD, kit, rapid clotting, clinical
Coag-Sense Test Strip Kit - 50 Ct
COAGUSENSE INC.
100218
In Commercial Distribution

  • 00861900000336 ()
03P56-50

  • Prothrombin time (PT) IVD, kit, rapid clotting, clinical
Skin Surface Temperature Probe Reusable; stainless steel disc; epoxy backing; size = 3/8" (9.5mm); length = 10' (3.1m); wgt = 1 lb (454g)
Philips Medical Systems Hsg
Skin Surface Temperature Probe
Not in Commercial Distribution

  • 00884838001015 ()
21078A

  • General-purpose patient temperature probe, reusable
Esophageal/Rectal Temperature Probe Reusable; vinyl tip end lead; size 10Fr; probe length = 10' (3.1m); wgt = 1 lb (454g)
Philips Medical Systems Hsg
Esophageal/Rectal Temperature Probe
Not in Commercial Distribution

  • 00884838001008 ()
21076A

  • General-purpose patient temperature probe, reusable
Esophageal/Rectal Temperature Probe Reusable; vinyl tip end lead; size = 15 Fr; probe length = 10' (3.1m); wgt = l lb (454g)
Philips Medical Systems Hsg
Esophageal/Rectal Temperature Probe
Not in Commercial Distribution

  • 00884838000995 ()
21075A

  • General-purpose patient temperature probe, reusable
A device that is applied to the tip of a contact type tonometer in order to avoid cross-infection between patients. The device is made of plastic. This is a single-use device.
AUTOMATED OPHTHALMICS, INC.
AO316
In Commercial Distribution

  • 00860000603805 ()


  • Ophthalmic tonometer tip cover
LeadCare® Blood Lead Control Kit
MAGELLAN DIAGNOSTICS, INC.
LeadCare®
In Commercial Distribution

  • 00850355006161 ()
70-3440

  • Lead (Pb) analyser IVD
TRAY,CATHETER,INTERMITTENT,14F,STERIL
MEDLINE INDUSTRIES, INC.
DYNDT1041
In Commercial Distribution

  • 40884389228679 ()
  • 10884389228678 ()
DYNDT1041

  • Indwelling urethral catheterization kit, adult
Ureteral Stent - 4 Pack
Q UROLOGICAL CORPORATION
NP377SS0724
In Commercial Distribution

  • 10811503033528 ()
NP377SS0724

  • Polymeric ureteral stent
Ureteral Stent - 4 Pack
Q UROLOGICAL CORPORATION
NP377SS0726
In Commercial Distribution

  • 10811503033511 ()
NP377SS0726

  • Polymeric ureteral stent
Ureteral Stent - 4 Pack
Q UROLOGICAL CORPORATION
NP378SS0724
In Commercial Distribution

  • 10811503033481 ()


  • Polymeric ureteral stent
Ureteral Stent - 4 Pack
Q UROLOGICAL CORPORATION
NP378SS0726
In Commercial Distribution

  • 10811503033474 ()


  • Polymeric ureteral stent
Ureteral Stent - 4 Pack
Q UROLOGICAL CORPORATION
NP377SP0728
In Commercial Distribution

  • 10811503033436 ()


  • Polymeric ureteral stent
Ureteral Stent - 4 Pack
Q UROLOGICAL CORPORATION
NP377EO0828
In Commercial Distribution

  • 10811503033429 ()


  • Polymeric ureteral stent
Ureteral Stent - 4 Pack
Q UROLOGICAL CORPORATION
NP377ER0830
In Commercial Distribution

  • 10811503033412 ()


  • Polymeric ureteral stent
Ureteral Stent - 4 Pack
Q UROLOGICAL CORPORATION
NP377EO0826
In Commercial Distribution

  • 10811503033405 ()


  • Polymeric ureteral stent
Ureteral Stent - 4 Pack
Q UROLOGICAL CORPORATION
NP377SL7526
In Commercial Distribution

  • 10811503033399 ()


  • Polymeric ureteral stent
Ureteral Stent - 4 Pack
Q UROLOGICAL CORPORATION
NP331TP0724
In Commercial Distribution

  • 10811503033382 ()


  • Polymeric ureteral stent
Ureteral Stent - 4 Pack
Q UROLOGICAL CORPORATION
NP330SP0626
In Commercial Distribution

  • 10811503033375 ()


  • Polymeric ureteral stent
Ureteral Stent - 4 Pack
Q UROLOGICAL CORPORATION
NP331TP0726
In Commercial Distribution

  • 10811503033368 ()


  • Polymeric ureteral stent
Ureteral Stent - 4 Pack
Q UROLOGICAL CORPORATION
NP376SJ0728
In Commercial Distribution

  • 10811503033337 ()


  • Polymeric ureteral stent
Ureteral Stent - 4 Pack
Q UROLOGICAL CORPORATION
NP376SJ0726
In Commercial Distribution

  • 10811503033320 ()


  • Polymeric ureteral stent
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