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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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STOMA® - ESAM3701011

Tongue depressor, Wieder, 14cm
Storz am Mark GmbH
3701.01
In Commercial Distribution

  • ESAM3701010 ()
  • ESAM3701011 ()
3701.01

  • Tongue depressor, surgical

STOMA® - ESAM3700001

Tongue spatula, Brünings, 19cm
Storz am Mark GmbH
3700.00
In Commercial Distribution

  • ESAM3700000 ()
  • ESAM3700001 ()
3700.00

  • Tongue depressor, surgical

Symmetry Surgical - 00887482090299

Symmetry® Valvulotome, Retrograde, 6 1/4 in
SYMMETRY SURGICAL INC.
55-8685
In Commercial Distribution

  • 00887482090299 ()

  • Length: 6.25 Inch
55-8685

  • Valvulotome

Symmetry Surgical - 00887482090282

Symmetry® Valvulotome, Antegrade, 9 1/4 in
SYMMETRY SURGICAL INC.
55-8684
In Commercial Distribution

  • 00887482090282 ()

  • Length: 9.25 Inch
55-8684

  • Valvulotome

Symmetry Wieder - 00887482049174

Symmetry® Depressor, Wieder Tongue, 36 mm Wide, Large
SYMMETRY SURGICAL INC.
72-0141
In Commercial Distribution

  • 00887482049174 ()

  • Width: 36 Millimeter
72-0141

  • Tongue depressor, surgical

Symmetry Surgical - 00887482049969

Symmetry® Valvulotome, Antegrade, 12 in
SYMMETRY SURGICAL INC.
55-8683
In Commercial Distribution

  • 00887482049969 ()

  • Length: 12 Inch
55-8683

  • Valvulotome

Symmetry Surgical - 00887482049952

Symmetry® Valvulotome, Retrograde, 12 in
SYMMETRY SURGICAL INC.
55-8682
In Commercial Distribution

  • 00887482049952 ()

  • Length: 12 Inch
55-8682

  • Valvulotome

Symmetry Surgical - 00887482049945

Symmetry® Valvulotome, Antegrade, 6 1/4 in
SYMMETRY SURGICAL INC.
55-8681
In Commercial Distribution

  • 00887482049945 ()

  • Length: 6.25 Inch
55-8681

  • Valvulotome

Symmetry Surgical - 00887482049938

Symmetry® Valvulotome, Retrograde, 9 7/8 in
SYMMETRY SURGICAL INC.
55-8680
In Commercial Distribution

  • 00887482049938 ()

  • Length: 9.875 Inch
55-8680

  • Valvulotome

BEAR - B351B800030

Hartmann Tongue Depressor
Mytamed, Inc.
8.00.03
Not in Commercial Distribution

  • B351B800030 ()
8.00.03

  • Tongue depressor, surgical

mytaMed - B351800030

Hartmann Tongue Depressor
Mytamed, Inc.
8.00.03
Not in Commercial Distribution

  • B351800030 ()
8.00.03

  • Tongue depressor, surgical

mytaMed - B351800020

Wieder Tongue Depressor, Large
Mytamed, Inc.
8.00.02
Not in Commercial Distribution

  • B351800020 ()
8.00.02

  • Tongue depressor, surgical

mytaMed - B351800010

Wieder Tongue Depressor, Small
Mytamed, Inc.
8.00.01
Not in Commercial Distribution

  • B351800010 ()
8.00.01

  • Tongue depressor, surgical

Symmetry Andrew - 00887482049150

Symmetry® Depressor, Andrew Tongue, 17 mm Wide
SYMMETRY SURGICAL INC.
72-0130
In Commercial Distribution

  • 00887482049150 ()

  • Width: 17 Millimeter
72-0130

  • Tongue depressor, surgical

PILLING - 24026704507232

ANDREWS DEPRESSOR LARGE
TELEFLEX INCORPORATED
IPN002356
In Commercial Distribution

  • 24026704507232 ()
  • 04026704507238 ()

  • Length: 114 Millimeter
  • Width: 100 Millimeter
070107

  • Tongue depressor, surgical

Burkhart 3-0 Chromic Suture 27", C-6 Needle - 00854212006011

No Description
BURKHART DENTAL SUPPLY CO., THE
72720761
In Commercial Distribution

  • 10854212006018 ()
  • 00854212006011 ()


  • Catgut suture, chromic

PULSAR - 04048551242513

KARL STORZ PULSAR II Stroboscope
Karl Storz GmbH & Co. KG
40160120
In Commercial Distribution

  • 04048551242513 ()


  • Laryngostroboscope system

UNIVERSAL PLUS - 30653405010818

UNIVERSAL PLUS LAPAROSCOPIC ELECTRODE WITH ESCHAR-RESISTANT COATING - SUCTION/IRRIGATION, 5MM X 27CM NEEDLE
Conmed Corporation
60-5274-927
Not in Commercial Distribution

  • 20653405010811 ()
  • 30653405010818 ()
  • 00653405010817 ()

  • Length: 27 Centimeter
  • Outer Diameter: 5 Millimeter
60-5274-927

  • Open-surgery electrosurgical electrode, monopolar, single-use

CATALINA WATER BATH 2000 110V Serial Number: - D248429040

Dental lab water bath for softening wax
HAGER WORLDWIDE, INC.
42904
In Commercial Distribution

  • D248429040 ()


  • Laboratory water bath

CranialMask Tracker - 07613327097627

CranialMask Tracker
Stryker Leibinger GmbH & Co. KG
6000-390-000
In Commercial Distribution

  • 37613327097628 ()
  • 07613327097627 ()
6000-390-000

  • Optical surgical navigation device tracking system

ARTSMedia Sperm Gradient Medium 90 % (AM-SDG Medium 90 %) - 05745000591091

Intended for human sperm separation by density gradient centrifugation.
Artsmedia Denmark ApS
100 ml
In Commercial Distribution

  • 05745000591091 ()
504100

  • IVF medium

ARTSMedia Sperm Gradient Medium 90 % (AM-SDG Medium 90 %) - 05745000591084

Intended for human sperm separation by density gradient centrifugation.
Artsmedia Denmark ApS
50 ml
In Commercial Distribution

  • 05745000591084 ()
504050

  • IVF medium

ARTSMedia Sperm Gradient Medium 90 % (AM-SDG Medium 90 %) - 05745000591077

Intended for human sperm separation by density gradient centrifugation.
Artsmedia Denmark ApS
20 ml
In Commercial Distribution

  • 05745000591077 ()
504020

  • IVF medium

Alleset - 16931918177731

Diathermy Pouch_50x60cm_1-Pocket_w/ Adhesive_250ea/cs
GRI Medical & Electronic Technology Co., Ltd.
Model 80-14815
In Commercial Distribution

  • 06931918177734 ()
  • 16931918177731 ()


  • Instrument management bag

Alleset - 16931918163321

Diathermy Pouch_40x32cm_2-Pockets_w/ adhesive_Sterile_100ea/cs
GRI Medical & Electronic Technology Co., Ltd.
Model 80-14805-S
In Commercial Distribution

  • 06931918163324 ()
  • 16931918163321 ()


  • Instrument management bag

Alleset - 16931918115344

Diathermy Pouch_30x50cm_3-Pockets_w/ adhesive_Sterile_100ea/cs
GRI Medical & Electronic Technology Co., Ltd.
Model 80-14806-S
In Commercial Distribution

  • 06931918115347 ()
  • 16931918115344 ()


  • Instrument management bag

Alleset - 16931918148762

Diathermy Pouch, 40x32cm, 2-Pockets, w/ Adhesive_500ea/cs
GRI Medical & Electronic Technology Co., Ltd.
Model 80-14805
In Commercial Distribution

  • 06931918148765 ()
  • 16931918148762 ()


  • Instrument management bag

Friendship Medical - 16955739020144

No Description
Xi'an Friendship Medical Electronics Co.,Ltd.
SEAg-P-2500/20×27
In Commercial Distribution

  • 26955739020141 ()
  • 16955739020144 ()
  • 06955739020147 ()


  • Electrode conductive medium

Friendship Medical - 16955739020137

No Description
Xi'an Friendship Medical Electronics Co.,Ltd.
SEAg-P-1500/20×27
In Commercial Distribution

  • 26955739020134 ()
  • 16955739020137 ()
  • 06955739020130 ()


  • Electrode conductive medium

Friendship Medical - 16955739020090

No Description
Xi'an Friendship Medical Electronics Co.,Ltd.
SEAg-T-2500/20×27
In Commercial Distribution

  • 26955739020097 ()
  • 16955739020090 ()
  • 06955739020093 ()


  • Electrode conductive medium

Friendship Medical - 16955739020083

No Description
Xi'an Friendship Medical Electronics Co.,Ltd.
SEAg-T-1500/20×27
In Commercial Distribution

  • 26955739020080 ()
  • 16955739020083 ()
  • 06955739020086 ()


  • Electrode conductive medium

Friendship Medical - 16955739020052

No Description
Xi'an Friendship Medical Electronics Co.,Ltd.
SEAg-S-2500/20×27
In Commercial Distribution

  • 26955739020059 ()
  • 16955739020052 ()
  • 06955739020055 ()


  • Electrode conductive medium

Friendship Medical - 16955739020045

No Description
Xi'an Friendship Medical Electronics Co.,Ltd.
SEAg-S-1500/20×27
In Commercial Distribution

  • 26955739020042 ()
  • 16955739020045 ()
  • 06955739020048 ()


  • Electrode conductive medium

SAHARA - 04028339710236

Warming equipment with heatable agitation plate for thawing and warming of up to 3 blood components packed in plastic bags
Transmed Medizintechnik GmbH & Co. KG
SAHARA-III basic model 115V
In Commercial Distribution

  • 04028339710236 ()
97.8710.502

  • Cryopreserved blood/tissue thawing unit

SAHARA - 04028339710939

Warming equipment with passive agitation plate for thawing and warming of up to 6 blood components packed in plastic bags
Transmed Medizintechnik GmbH & Co. KG
SAHARA-III MAXITHERM 115V
In Commercial Distribution

  • 04028339710939 ()
97.8710.802

  • Cryopreserved blood/tissue thawing unit

Max Pulse - 00191237000038

No Description
Medicore Co., Ltd.
Max Pulse
In Commercial Distribution

  • 40191237000036 ()
  • 10191237000035 ()
  • 00191237000038 ()
  • 30191237000039 ()
  • 20191237000032 ()
Max Pulse

  • Sphygmograph

SA-3000P - 00191237000014

No Description
Medicore Co., Ltd.
SA-3000P
In Commercial Distribution

  • 10191237000011 ()
  • 00191237000014 ()
SA-3000P

  • Sphygmograph

K-2oem ALT-AIRE+ - 00817012022353

On-Demand Low Air loss Expandable mattress system, 80"-84"-88" x 36"-42"-48" x 10"
KAP MEDICAL
U-K-2oemXMS
In Commercial Distribution

  • 00817012022353 ()
U-K-2oemXMS

  • Low-air-loss bed

K-6 TURN-ZONE - 00817012022308

Alternating Pressure Lateral Rotation Expandable Mattress System, 80"-84"-88" x 36"-42"-48" x 10"
KAP MEDICAL
U-K-6XMS
In Commercial Distribution

  • 00817012022308 ()
U-K-6XMS

  • Low-air-loss bed

K-2oem ALT-AIRE+ - 00817012022193

On-Demand Low Air Loss Expandable Mattress System, 80"-84"-88" x 36"~39-42"-48" x 10"
KAP MEDICAL
K-2oemXMS
In Commercial Distribution

  • 00817012022193 ()
K-2oemXMS

  • Low-air-loss bed
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