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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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Criticare - B4388100E1US0

nGenuity with CO2
CRITICARE TECHNOLOGIES, INC.
nGenuity 8100E1
In Commercial Distribution

  • B4388100E1US0 ()


  • General-purpose multi-parameter bedside monitor

Compression Stocking - G420420

Suit with Sleeves
Gottfried Medical, Inc.
420
In Commercial Distribution

  • G420420 ()
420

  • Compression/pressure shirt/pants

Compression Stocking - G420412

Vest with Sleeves
Gottfried Medical, Inc.
412
In Commercial Distribution

  • G420412 ()
412

  • Compression/pressure shirt/pants

PC - 00026072019290

RETRACTOR-HOSE ASSEMBLY WITH
Allied Medical, LLC
15-61-6006
In Commercial Distribution

  • 00026072019290 ()


  • Custom-made medical device mount

B&F - 00026072023495

Mask with Nebulizer
Allied Medical, LLC
64085
In Commercial Distribution

  • 00026072023495 ()


  • Benchtop nebulizer, non-heated

Plastalune - 00082161104384

Armboards with Stockinette
BROWNMED, INC.
SP10438-25
In Commercial Distribution

  • 00082161104384 ()


  • Hand/finger splint, reusable

Plastalume - 00082161104377

Armboards with Stockinette
BROWNMED, INC.
SP10437-25
In Commercial Distribution

  • 00082161104377 ()


  • Hand/finger splint, reusable

Plastalume - 00082161104360

Armboards with Stockinette
BROWNMED, INC.
SP10436-25
In Commercial Distribution

  • 00082161104360 ()


  • Hand/finger splint, reusable

Plastalume - 00082161104346

Armboards with Stockinette
BROWNMED, INC.
SP10434-25
In Commercial Distribution

  • 00082161104346 ()


  • Hand/finger splint, reusable

Plastalume - 00082161104315

Armboards with Stockinette
BROWNMED, INC.
SP10431-25
In Commercial Distribution

  • 00082161104315 ()


  • Hand/finger splint, reusable

AUTOFIX - 03700586902688

Tray with Lid
Stryker GmbH
603-0005
In Commercial Distribution

  • 03700586902688 ()
603-0005

  • Instrument tray, reusable

In'tech Medical SAS - 03664888000346

K-WIRE WITH GRADUATION
IN'TECH MEDICAL
S06ITM365-C628
In Commercial Distribution

  • 03664888000346 ()


  • Hand-held surgical retractor, reusable

NOBILIUM - M4820100NK0

WITALLOY WITH PLATINUM
CMP INDUSTRIES LLC
0100NK
In Commercial Distribution

  • M4820100NK0 ()


  • Dental casting non-noble alloy

PASS LP - 03613720240846

SPEEDRIVER WITH T-HANDLE
MEDICREA INTERNATIONAL
A02230080
Not in Commercial Distribution

  • 03613720240846 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable

KARMA - 00840606116169

Tensioner with Cutoff
SPINAL ELEMENTS, INC.
75120-000
In Commercial Distribution

  • 00840606116169 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

Medline Industries, Inc. - 10884389860366

TRANSDUCER WITH WINGS
MEDLINE INDUSTRIES, INC.
DYNJTRANSWG
In Commercial Distribution

  • 10884389860366 ()
  • 40884389860367 ()
DYNJTRANSWG

  • General surgical procedure kit, non-medicated, single-use

Powered breast pump - 08800051100504

2pumps with iBox
IMANI
imani i2Plus
Not in Commercial Distribution

  • 08800051100504 ()


  • Breast pump, electric

Millennium - 00190776116729

Posts with screw
Avalign Technologies, Inc.
2000-162-114
In Commercial Distribution

  • 00190776116729 ()


  • Device sterilization/disinfection container, reusable

Monoject - 10884521544833

Bluntfill with Filter
Cardinal Health, Inc.
11811022F
In Commercial Distribution

  • 10884521544833 ()
  • 30884521544837 ()
  • 20884521544830 ()

  • Length: 1.5 Inch
  • Needle Gauge: 18 Gauge
11811022F

  • Medicine preparation needle/cannula, sterile

CONMED - 10845854029992

OSTEOTOME WITH MARKINGS
Conmed Corporation
8213
In Commercial Distribution

  • 20845854029999 ()
  • 10845854029992 ()
8213

  • Bone file/rasp, manual, reusable

MILLENNIUM - 00190776315764

Probe, with eye,
Avalign Technologies, Inc.
0-42612
In Commercial Distribution

  • 00190776315764 ()


  • Neurosurgical probe

Nautilus CA - 00190837091071

Awl, With Stop
Life Spine, Inc.
116-234
In Commercial Distribution

  • 00190837091071 ()
116-234

  • Bone awl, single-use

Centerline Thoracolumbar Spinal System - 00190837064075

Awl with Stop
Life Spine, Inc.
148-193
In Commercial Distribution

  • 00190837064075 ()
148-193

  • Bone awl, single-use

Prima - D76845009K0

Base with Anatite
KEYSTONE DENTAL, INC.
45009K
Not in Commercial Distribution

  • D76845009K0 ()

  • Outer Diameter 10.0 - 10.0 mm
45009K

  • Dental implant suprastructure, permanent, preformed

Prima - D76845008K0

Base with Anatite
KEYSTONE DENTAL, INC.
45008K
Not in Commercial Distribution

  • D76845008K0 ()

  • Outer Diameter 10.0 - 10.0 mm
45008K

  • Dental implant suprastructure, permanent, preformed

Prima - D76845007K0

Base with Anatite
KEYSTONE DENTAL, INC.
45007K
Not in Commercial Distribution

  • D76845007K0 ()

  • Outer Diameter 10.0 - 10.0 mm
45007K

  • Dental implant suprastructure, permanent, preformed

BioStamp® nPoint - G012BRCA02

Adhesive with hydrogel
Medidata Solutions, Inc.
BRCA02
In Commercial Distribution

  • G012MC0009 ()
  • G012BRCA02 ()
  • B493BRCA02 ()


  • Biomechanical function analysis/rehabilitation software
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder

N/A - 00889095141818

Tap with Stop
GLOBUS MEDICAL, INC.
610.741
In Commercial Distribution

  • 00889095141818 ()


  • Bone tap, reusable

Diamond Orthopedic, LLC - B551DMD311430

Handle with quick-coupling
DIAMOND ORTHOPEDIC, LLC
DMD-311-430
In Commercial Distribution

  • B551DMD311430 ()
DMD-311-430

  • Surgical screwdriver, reusable

Peritron - 10627825006283

with Vaginal Sensor
Laborie Medical Technologies Canada ULC
PRN09301
In Commercial Distribution

  • 10627825006283 ()


  • Perineometer

Peritron - 10627825006276

with Anal Sensor
Laborie Medical Technologies Canada ULC
PRN09300
In Commercial Distribution

  • 10627825006276 ()


  • Perineometer

CARDINAL HEALTH - 10888439260656

SHOULDER WITH POUCH
Cardinal Health 200, LLC
SOPOCSPRA4
In Commercial Distribution

  • 50888439260654 ()
  • 10888439260656 ()
SOPOCSPRA4

  • Orthopaedic surgical procedure kit, non-medicated, single-use

CARDINAL HEALTH - 10888439274837

ANGIOPLASTY WITH STENT
Cardinal Health 200, LLC
SCV41APPD3
In Commercial Distribution

  • 50888439274835 ()
  • 10888439274837 ()
SCV41APPD3

  • Angiography kit

CARDINAL HEALTH - 10888439270501

SHOULDER WITH POUCH
Cardinal Health 200, LLC
SOPOCSPRA5
In Commercial Distribution

  • 50888439270509 ()
  • 10888439270501 ()
SOPOCSPRA5

  • Orthopaedic surgical procedure kit, non-medicated, single-use

CARDINAL HEALTH - 10888439267686

OCULOPLASTIC WITH PREP
Cardinal Health 200, LLC
SEY31OCCD2
In Commercial Distribution

  • 50888439267684 ()
  • 10888439267686 ()
SEY31OCCD2

  • Ophthalmic surgical procedure kit, non-medicated, single-use

GAMMA - 04546540661340

K-Wire With Washer
Stryker GmbH
1320-0016S
In Commercial Distribution

  • 04546540661340 ()

  • Diameter: 3.2 Millimeter
  • Length: 500.0 Millimeter
1320-0016S

  • Orthopaedic guidewire, reusable

NA - 04546540605191

K-Wire with Washer
Stryker GmbH
1806-0051
In Commercial Distribution

  • 04546540605191 ()

  • Diameter: 3.0 Millimeter
  • Length: 285.0 Millimeter
1806-0051

  • Orthopaedic guidewire, reusable

NA - 04546540604606

K-Wire with Washer
Stryker GmbH
1806-0051S
In Commercial Distribution

  • 04546540604606 ()

  • Length: 285.0 Millimeter
  • Diameter: 3.0 Millimeter
1806-0051S

  • Orthopaedic guidewire, reusable

ImageWorks Panoura - 04547497759067

WITH CEPHALO(XP73)
YOSHIDA DENTAL MFG. CO., LTD., THE
ImageWorks Panoura C
In Commercial Distribution

  • 04547497759067 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

CARDINAL HEALTH - 10888439040401

CENTESIS WITH TURKEL
Cardinal Health 200, LLC
30-0307H
In Commercial Distribution

  • 50888439040409 ()
  • 10888439040401 ()
30-0307H

  • General surgical procedure kit, medicated

CARDINAL HEALTH - 10888439034486

OCULOPLASTIC WITH PREP
Cardinal Health 200, LLC
SEY31OCCDS
In Commercial Distribution

  • 50888439034484 ()
  • 10888439034486 ()
SEY31OCCDS

  • Ophthalmic surgical procedure kit, non-medicated, single-use

CARDINAL HEALTH - 10888439032673

CRANIOTOMY WITH BASIN
Cardinal Health 200, LLC
SNE69CRECF
In Commercial Distribution

  • 50888439032671 ()
  • 10888439032673 ()
SNE69CRECF

  • Craniotomy kit

CARDINAL HEALTH - 10888439096811

OCULOPLASTIC WITH PREP
Cardinal Health 200, LLC
SEY31OCCDT
In Commercial Distribution

  • 50888439096819 ()
  • 10888439096811 ()
SEY31OCCDT

  • Ophthalmic surgical procedure kit, non-medicated, single-use

Altus Spine Interbody Fusion System - 00843210131771

Inserter with Tabs
Altus Spine, LLC
780-0021
In Commercial Distribution

  • 00843210131771 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable

Brickyard Stand-Alone ALIF - 00843210179964

Awl With Sleeve
Altus Spine, LLC
1030-0100
In Commercial Distribution

  • 00843210179964 ()


  • Bone awl, reusable

Indy Standalone - 00843210147291

Awl With Sleeve
Altus Spine, LLC
1030-0100
In Commercial Distribution

  • 00843210147291 ()


  • Bone awl, reusable

CARDINAL HEALTH - 10888439043105

ANGIOPLASTY WITH STENT
Cardinal Health 200, LLC
SCV41APPD1
In Commercial Distribution

  • 50888439043103 ()
  • 10888439043105 ()
SCV41APPD1

  • Angiography kit

CARDINAL HEALTH - 10888439130096

SHOULDER WITH POUCH
Cardinal Health 200, LLC
SOPOCSPRAE
In Commercial Distribution

  • 50888439130094 ()
  • 10888439130096 ()
SOPOCSPRAE

  • Orthopaedic surgical procedure kit, non-medicated, single-use

CARDINAL HEALTH - 10888439057683

SHOULDER WITH POUCH
Cardinal Health 200, LLC
SOPOCSPRA2
In Commercial Distribution

  • 50888439057681 ()
  • 10888439057683 ()
SOPOCSPRA2

  • Orthopaedic surgical procedure kit, non-medicated, single-use

CARDINAL HEALTH - 10888439058109

CENTESIS WITH TURKEL
Cardinal Health 200, LLC
30-0307I
In Commercial Distribution

  • 50888439058107 ()
  • 10888439058109 ()
30-0307I

  • General surgical procedure kit, medicated
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