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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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ZILIENT - 10852528005527

6 gram tip, long taper, .018" diameter 300cm
Cardiovascular Systems, Inc.
06G-300-018
Not in Commercial Distribution

  • 30852528005521 ()
  • 10852528005527 ()

  • Max Tip Diameter: 0.018 inches; Tip Support: 6 grams; Length: 300cm
7-10049-08

  • Peripheral vascular guidewire, manual

ZILIENT - 10852528005510

6gram tip, long taper, .018" diameter 195cm
Cardiovascular Systems, Inc.
06G-195-018
Not in Commercial Distribution

  • 30852528005514 ()
  • 10852528005510 ()

  • Max Tip Diameter: 0.018 inches; Tip Support: 6 grams; Length: 195cm
7-10049-07

  • Peripheral vascular guidewire, manual

ZILIENT - 10852528005503

6gram tip, long taper, .014" diameter 300cm
Cardiovascular Systems, Inc.
06G-300-014
Not in Commercial Distribution

  • 30852528005507 ()
  • 10852528005503 ()

  • Max Tip Diameter: 0.014 inches; Tip Support: 6 grams; Length: 300cm
7-10049-06

  • Peripheral vascular guidewire, manual

ZILIENT - 10852528005497

6gram tip, long taper, .014" diameter 195cm
Cardiovascular Systems, Inc.
06G-195-014
Not in Commercial Distribution

  • 30852528005491 ()
  • 10852528005497 ()

  • Max Tip Diameter: 0.014 inches; Tip Support: 6 grams; Length: 195cm
7-10049-05

  • Peripheral vascular guidewire, manual

ZILIENT - 10852528005480

4gram tip, short taper, .018" diameter 300cm
Cardiovascular Systems, Inc.
04G-300-018
Not in Commercial Distribution

  • 30852528005484 ()
  • 10852528005480 ()

  • Max Tip Diameter: 0.018 inches; Tip Support: 4 grams; Length: 300cm
7-10049-04

  • Peripheral vascular guidewire, manual

ZILIENT - 10852528005473

4gram tip, short taper, .018" diameter 195cm
Cardiovascular Systems, Inc.
04G-195-018
Not in Commercial Distribution

  • 10852528005473 ()
  • 30852528005477 ()

  • Max Tip Diameter: 0.018 inches; Tip Support: 4 grams; Length: 195cm
7-10049-03

  • Peripheral vascular guidewire, manual

Extended Length ViperWire Advance - 10852528005466

ViperWire, Advance, Extended Length, Peripheral, 0.018" Dia spring tip, 475cm, 5 Pack
Cardiovascular Systems, Inc.
VPR-GW-EL18
In Commercial Distribution

  • 10852528005466 ()
  • 30852528005460 ()

  • Length: 475 Centimeter
  • Shaft Diameter 0.014 inches
  • Max Tip Diameter 0.018 inches
7-10035-02

  • Peripheral vascular guidewire, manual

Extended Length ViperWire Advance - 10852528005459

ViperWire, Advance, Extended Length, Peripheral, 0.014" Dia spring tip, 475cm, 5 Pack
Cardiovascular Systems, Inc.
VPR-GW-EL14
In Commercial Distribution

  • 30852528005453 ()
  • 10852528005459 ()

  • Length: 475 Centimeter
  • Shaft Diameter 0.014 inches
  • Max Tip Diameter 0.014 inches
7-10035-01

  • Peripheral vascular guidewire, manual

Diamondback Coronary - 10852528005442

SALINE INFUSION PUMP (SIP)
Cardiovascular Systems, Inc.
SIP-3000
In Commercial Distribution

  • 10852528005442 ()
7-10037-01

  • Atherectomy system saline/lubricant pump

Diamondback Peripheral - 10852528005008

Diamondback Peripheral, Exchangeable Series, Cartridge, 1.75 Solid, 180 cm shaft
Cardiovascular Systems, Inc.
DBP-CART-175SOL180
In Commercial Distribution

  • 10852528005008 ()

  • Intro Sheath: 6 Fr
  • Max OD: 0.069 inches
  • Crown Type: Solid
  • High Speed: 120krpm
  • Medium Speed: 90krpm
  • Low Speed: 60krpm
  • Guidewire: 0.014 inches
  • Shaft Length: 180cm
  • Nose Length: 30mm
  • Crown Diameter: 1.75mm
7-10031-09

  • Mechanical atherectomy system catheter, peripheral

Diamondback Coronary - 10850026568698

DIAMONDBACK CORONARY, CLASSIC CROWN, 1.25MM, 135CM SHAFT
Cardiovascular Systems, Inc.
DBEC-125
In Commercial Distribution

  • 10850026568698 ()

  • Low Speed 80krpm
  • Medium Speed krpm
  • High Speed 120krpm
  • Crown Type Classic
  • Max OD 0.0495in
  • Intro Sheath 6Fr
  • Crown Diameter 1.25mm
  • Nose Length 5mm
  • Shaft Length: 135 Centimeter
  • Guidewire Size OD 0.012in
7-10098-01

  • Mechanical atherectomy system, coronary, line-powered

2F AND 3F VASCU-SHEATH TEARAWAY INTRODUCER2F AND 3F VASCU-SHEATH TEARAWAY INTROD - 00884908104196

2F (0.7MM ID) X 2CM2F (0.7MM ID) TEARAWAY INTRODUCER SETTEARAWAY W/60CM STEEL WIREW/60CM STEEL WI & 22GA SAFETY NEEDLE
Medical Components, Inc.
MR1902622S
Not in Commercial Distribution

  • 30884908104197 ()
  • 00884908104196 ()
  • 50884908104191 ()
MR1902622S

  • Vascular catheter introduction needle

2F AND 3F VASCU-SHEATH TEARAWAY INTRODUCER2F AND 3F VASCU-SHEATH TEARAWAY INTROD - 00884908104189

2F (0.7MM ID) X 2CM2F (0.7MM ID) TEARAWAY INTRODUCER SETTEARAWAY W/60CM STEEL WIREW/60CM STEEL WI & 24GA SAFETY NEEDLE
Medical Components, Inc.
MR1902624S
Not in Commercial Distribution

  • 30884908104180 ()
  • 00884908104189 ()
  • 50884908104184 ()
MR1902624S

  • Vascular catheter introduction needle

2F AND 3F VASCU-SHEATH TEARAWAY INTRODUCER2F AND 3F VASCU-SHEATH TEARAWAY INTROD - 00884908104295

3F (1.1MM ID) X 3CM3F (1.1MM ID) TEARAWAY INTRODUCER SETTEARAWAY W/60CM STEEL WIREW/60CM STEEL WI & 22GA SAFETY NEEDLE
Medical Components, Inc.
MR1903622S
Not in Commercial Distribution

  • 50884908104290 ()
  • 30884908104296 ()
  • 00884908104295 ()
MR1903622S

  • Vascular catheter introduction needle

2F AND 3F VASCU-SHEATH TEARAWAY INTRODUCER2F AND 3F VASCU-SHEATH TEARAWAY INTROD - 00884908104288

3F (1.1MM ID) X 3CM3F (1.1MM ID) TEARAWAY INTRODUCER SETTEARAWAY W/60CM STEEL WIREW/60CM STEEL WI & 24GA SAFETY NEEDLE
Medical Components, Inc.
MR1903624S
Not in Commercial Distribution

  • 50884908104283 ()
  • 30884908104289 ()
  • 00884908104288 ()
MR1903624S

  • Vascular catheter introduction needle

KC 105 Adapter - M996KC1050

Adult Adapter - 15mm ID/22mm OD x15mm ID/22mm OD. Fits components of adult ventilator circuits. Molded of polycarbonate. Reusable.
INSTRUMENTATION INDUSTRIES, INCORPORATED
KC 105
In Commercial Distribution

  • M996KC1052 ()
  • M996KC1050 ()
KC 105

  • Straight/elbow breathing circuit connector, reusable

SG 101-D Reducing Adapter - M996SG101D0

Reducing Adapter for use in breathing/ventilator circuit. 15mm ID x 22mm ID. Molded of polystyrene butadiene. Single Patient Use.
INSTRUMENTATION INDUSTRIES, INCORPORATED
SG 101-D
In Commercial Distribution

  • M996SG101D6 ()
  • M996SG101D0 ()
  • M996SG101D4 ()
SG 101-D

  • Straight/elbow breathing circuit connector, single-use

PF 1510 Reducing Silicone Rubber Connector - M996PF15100

Reducing Connector - 15mm ID x 10mm ID. Fits components of pediatric to neonatal ventilator circuits. Molded of silicone rubber. Reusable.
INSTRUMENTATION INDUSTRIES, INCORPORATED
PF 1510
In Commercial Distribution

  • M996PF15102 ()
  • M996PF15100 ()
  • M996PF15105 ()
PF 1510

  • Straight/elbow breathing circuit connector, reusable

RAPID 20 E™ - 03573026588526

4-hour ID of Enterobacteriaceae. API®strips give accurate ID based on extensive databases and are standardized, easy-to-use test systems.
BIOMERIEUX SA
RAPID 20 E™
In Commercial Distribution

  • 03573026048617 ()
  • 03573026588526 ()


  • Multiple gram negative bacteria species culture isolate identification IVD, kit

SUPER SHEATH 2.1SUPER SHEATH 2.1 - 00884908145519

7F (2.3MM ID) X 10CM7F (2.3MM ID TEARAWAY INTRODUCER SETTEARAWAY W/NITINOL GUIDEWIREW/NITINOL GUI W/RADIOPAQUE TIPW/RADIOPAQUE TIP
Medical Components, Inc.
DMR210780
Not in Commercial Distribution

  • 50884908145514 ()
  • 30884908145510 ()
  • 00884908145519 ()
DMR210780

  • Vascular catheter introduction needle

VASCU-SHEATH® - 00884908145427

3F (1.0MM ID) X 5CM3F (1.0MM ID) TEARAWAY INTRODUCER SETTEARAWAY W/NITINOL GUIDEWIREW/NITINOL GUI W/RADIOPAQUE TIPW/RADIOPAQUE TIP
Medical Components, Inc.
DMR190300
Not in Commercial Distribution

  • 30884908145428 ()
  • 00884908145427 ()
  • 50884908145422 ()
DMR190300

  • Vascular catheter introduction needle

Trulink - 10841522127373

SAMPLE LINE,AGENT,MALE LUER,SPU,7',50/BOX
SPACELABS HEALTHCARE (WASHINGTON), INC
NIBP Hoses and adapters
In Commercial Distribution

  • 00841522127376 ()
  • 10841522127373 ()

  • 1.19mm ID, 213 cm length
162-0047-01

  • Patient monitoring system module, multiple-gas

Ultracheck - 10841522106651

BP CUFF,UC NYLON,1T-16IN,LG.AD,32-42CM,NF,EA
Statcorp Medical
UltraCheck BP Cuffs
In Commercial Distribution

  • 10841522106651 ()

  • 32-42 cm ID, 16" tube
US3242-16S

  • Blood pressure cuff, reusable

Novation - 10885862537379

No Description
Exactech, Inc.
140-40-55
In Commercial Distribution

  • 10885862537379 ()

  • 40mm ID
  • Size Group 5
140-40-55

  • Non-constrained polyethylene acetabular liner

Novation - 10885862537362

No Description
Exactech, Inc.
140-40-54
In Commercial Distribution

  • 10885862537362 ()

  • Size Group 4
  • 40mm ID
140-40-54

  • Non-constrained polyethylene acetabular liner

Novation - 10885862537355

No Description
Exactech, Inc.
140-40-53
In Commercial Distribution

  • 10885862537355 ()

  • 40mm ID
  • Size Group 3
140-40-53

  • Non-constrained polyethylene acetabular liner

Novation - 10885862537348

No Description
Exactech, Inc.
140-36-55
In Commercial Distribution

  • 10885862537348 ()

  • Size Group 5
  • 36mm ID
140-36-55

  • Non-constrained polyethylene acetabular liner

Novation - 10885862537331

No Description
Exactech, Inc.
140-36-54
In Commercial Distribution

  • 10885862537331 ()

  • 36mm ID
  • Size Group 4
140-36-54

  • Non-constrained polyethylene acetabular liner

Novation - 10885862537324

No Description
Exactech, Inc.
140-36-53
In Commercial Distribution

  • 10885862537324 ()

  • Size Group 3
  • 36mm ID
140-36-53

  • Non-constrained polyethylene acetabular liner

Novation - 10885862537317

No Description
Exactech, Inc.
140-36-52
In Commercial Distribution

  • 10885862537317 ()

  • 36mm ID
  • Size Group 2
140-36-52

  • Non-constrained polyethylene acetabular liner
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