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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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CARDINAL HEALTH - 10195594736705

TOTAL JOINT B PACK
Cardinal Health 200, LLC
SOP73TBHP4
In Commercial Distribution

  • 50195594736703 ()
  • 10195594736705 ()
SOP73TBHP4

  • Orthopaedic surgical procedure kit, medicated

PANAVIA™ 21 - EKUR001054KA1

ED PRIMER Liquid B
KURARAY NORITAKE DENTAL INC.
#1054-KA
In Commercial Distribution

  • EKUR001054KA1 ()


  • Dental composite resin kit

CERABIEN™ ZR - EKUR1043831KA0

Internal Stain B+ 3g
KURARAY NORITAKE DENTAL INC.
104-3831KA
In Commercial Distribution

  • EKUR1043831KA0 ()


  • Dental appliance fabrication material, ceramic

CERABIEN™ ZR - EKUR1043651KA0

External Stain B+ 3g
KURARAY NORITAKE DENTAL INC.
104-3651KA
In Commercial Distribution

  • EKUR1043651KA0 ()


  • Dental appliance fabrication material, ceramic

CERABIEN™ - EKUR1031651KA0

Internal Stain B+ 3g
KURARAY NORITAKE DENTAL INC.
103-1651KA
In Commercial Distribution

  • EKUR1031651KA0 ()


  • Dental appliance fabrication material, ceramic

CERABIEN™ - EKUR1031481KA0

External Stain B+ 3g
KURARAY NORITAKE DENTAL INC.
103-1481KA
In Commercial Distribution

  • EKUR1031481KA0 ()


  • Dental appliance fabrication material, ceramic

Noritake Super Porcelain EX-3 - EKUR1023821KA0

Internal Stain B+ 3g
KURARAY NORITAKE DENTAL INC.
102-3821KA
In Commercial Distribution

  • EKUR1023821KA0 ()


  • Dental appliance fabrication material, ceramic

Noritake Super Porcelain EX-3 - EKUR1023631KA0

External Stain B+ 3g
KURARAY NORITAKE DENTAL INC.
102-3631KA
In Commercial Distribution

  • EKUR1023631KA0 ()


  • Dental appliance fabrication material, ceramic

CZR PRESS LF - EKUR1071801KA0

Internal Stain B+ 3g
KURARAY NORITAKE DENTAL INC.
107-1801KA
In Commercial Distribution

  • EKUR1071801KA0 ()


  • Dental appliance fabrication material, ceramic

CZR PRESS LF - EKUR1071621KA0

External Stain B+ 3g
KURARAY NORITAKE DENTAL INC.
107-1621KA
In Commercial Distribution

  • EKUR1071621KA0 ()


  • Dental appliance fabrication material, ceramic

MEDLINE INDUSTRIES, INC. - 10198459428784

OPEN HEART PACK B
MEDLINE INDUSTRIES, INC.
DYNJ54970B
In Commercial Distribution

  • 40198459428785 ()
  • 10198459428784 ()
DYNJ54970B

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

A.L.P.S. mvX™ - 00196449033379

ANKLE SCREW RACK B
Tyber Medical, LLC
770103060
In Commercial Distribution

  • 00196449033379 ()


  • Surgical instrument/implant rack

MEDLINE INDUSTRIES, INC. - 10198459442360

MINOR VASCULAR PACK B
MEDLINE INDUSTRIES, INC.
DYNJT4292
In Commercial Distribution

  • 40198459442361 ()
  • 10198459442360 ()
DYNJT4292

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

Etymotic Research - 00846430004955

ER7C series B Microphone ER7C series B Pre-Amp ER7-14 Probe Tubes
ETYMOTIC RESEARCH, INC.
ER7C Probe Microphone Series B
In Commercial Distribution

  • 00846430004955 ()


  • Audiometric/hearing aid tester

E-CUBE - 08809260470910

20:1, EP Type E-CUBE(C/B)+CUBE-EP+ACL(B)-42EP
Saeshin Precision Co., Ltd.
E-CUBE #1
In Commercial Distribution

  • 08809260470910 ()


  • Dental power tool system, line-powered

E-CUBE - 08809260470903

20:1, EM Type E-CUBE(C/B)+CUBE-EM+ACL(B)-42EM
Saeshin Precision Co., Ltd.
E-CUBE #2
In Commercial Distribution

  • 08809260470903 ()


  • Dental power tool system, line-powered

ANKYLOS® - EFRI310561902

Gold Coping, Degunorm b/1.5/6.0 & b/3.0/6.0 with screw
Dentsply Implants Manufacturing GmbH
31056190
Not in Commercial Distribution

  • EFRI310561902 ()
31056190

  • Dental implant suprastructure, permanent, preformed

ANKYLOS® - EFRI310561802

Gold Coping, Degunorm b/1.5/4.0 & b/3.0/4.0 with screw
Dentsply Implants Manufacturing GmbH
31056180
Not in Commercial Distribution

  • EFRI310561802 ()
31056180

  • Dental implant suprastructure, permanent, preformed

ANKYLOS® - EFRI310561302

Gold Coping, Permador b/1.5/6.0 & b/3.0/6.0 with screw
Dentsply Implants Manufacturing GmbH
31056130
Not in Commercial Distribution

  • EFRI310561302 ()
31056130

  • Dental implant suprastructure, permanent, preformed

ANKYLOS® - EFRI310561202

Gold Coping, Permador b/1.5/4.0 & b/3.0/4.0 with screw
Dentsply Implants Manufacturing GmbH
31056120
Not in Commercial Distribution

  • EFRI310561202 ()
31056120

  • Dental implant suprastructure, permanent, preformed

ANKYLOS® - EFRI310453102

Temporary Cap for Standard Abutment b/1.5/6.0 & b/3.0/6.0
Dentsply Implants Manufacturing GmbH
31045310
Not in Commercial Distribution

  • EFRI310453102 ()
31045310

  • Dental implant suprastructure, temporary, preformed, single-use

ANKYLOS® - EFRI310453002

Temporary Cap for Standard Abutment b/1.5/4.0 & b/3.0/4.0
Dentsply Implants Manufacturing GmbH
31045300
Not in Commercial Distribution

  • EFRI310453002 ()
31045300

  • Dental implant suprastructure, temporary, preformed, single-use

gSource - 00840314211088

Standard Scissors, 5 1/4 shaft, str, 3.4mm diameter, b/b
GSOURCE LLC
gS 30.4034
In Commercial Distribution

  • 00840314211088 ()
gS 30.4034

  • General-purpose surgical scissors, reusable

Brush&Bond® - M595S2880

Brush&Bond® Kit with Mini/Endo B&B Activator Brushes
PARKELL, INC.
S288
Not in Commercial Distribution

  • M595S2880 ()
S288

  • Dentine bonding agent/set

Skytron - 10841736117238

3 Inch LEG SECTION 6001k 6002&B 6500&HD 6600&B
SKYTRON LLC
1-011-02-33
In Commercial Distribution

  • 10841736117238 ()
1-011-02-33

  • Operating table patient pressure distribution pad, reusable

Skytron - 10841736117214

3 Inch HEAD SECTION 6001k 6002&B 6500&HD 6600&B
SKYTRON LLC
1-011-02-31
In Commercial Distribution

  • 10841736117214 ()
1-011-02-31

  • Operating table patient pressure distribution pad, reusable

N/A - 00840329809515

B&B ANGLED DOUBLE BEVEL BLADE SCISSORS; 4 1/2" (11.5CM)
BLACK & BLACK SURGICAL, INC.
B66131
In Commercial Distribution

  • 00840329809515 ()
B66131

  • General-purpose surgical scissors, reusable

Surgical Direct - B382SD90347711SC0

4 1/2" Stevens Tenotomy Scissors, Curved, B/B, Super Cut
Surgical Direct, Inc.
SD90347711SC
In Commercial Distribution

  • B382SD90347711SC0 ()
SD90347711SC

  • General-purpose surgical scissors, single-use

Brush&Bond® - 00810000529155

Brush&Bond® Kit with Mini/Endo B&B Activator Brushes
PARKELL, INC.
S288
In Commercial Distribution

  • 00810000529155 ()
S288

  • Dentine bonding agent/set

ANKYLOS® - 07392532222399

Gold Coping, Degunorm b/1.5/6.0 & b/3.0/6.0 with screw
Dentsply Implants Manufacturing GmbH
31056190
In Commercial Distribution

31056190

  • Dental implant suprastructure, permanent, preformed

ANKYLOS® - 07392532222382

Gold Coping, Degunorm b/1.5/4.0 & b/3.0/4.0 with screw
Dentsply Implants Manufacturing GmbH
31056180
In Commercial Distribution

31056180

  • Dental implant suprastructure, permanent, preformed

ANKYLOS® - 07392532222344

Gold Coping, Permador b/1.5/6.0 & b/3.0/6.0 with screw
Dentsply Implants Manufacturing GmbH
31056130
In Commercial Distribution

  • 07392532222344 ()
31056130

  • Dental implant suprastructure, permanent, preformed

ANKYLOS® - 07392532222337

Gold Coping, Permador b/1.5/4.0 & b/3.0/4.0 with screw
Dentsply Implants Manufacturing GmbH
31056120
In Commercial Distribution

  • 07392532222337 ()
31056120

  • Dental implant suprastructure, permanent, preformed

ANKYLOS® - 07392532221408

Temporary Cap for Standard Abutment b/1.5/6.0 & b/3.0/6.0
Dentsply Implants Manufacturing GmbH
31045310
In Commercial Distribution

31045310

  • Dental implant suprastructure, permanent, preformed

ANKYLOS® - 07392532221392

Temporary Cap for Standard Abutment b/1.5/4.0 & b/3.0/4.0
Dentsply Implants Manufacturing GmbH
31045300
In Commercial Distribution

31045300

  • Dental implant suprastructure, permanent, preformed

ANKYLOS® - 07392532221217

Laboratory Analog one piece 15° b/1.5/6.0 & b/3.0/6.0
Dentsply Implants Manufacturing GmbH
31045172
In Commercial Distribution

  • 07392532221217 ()
31045172

  • Dental implant suprastructure, temporary, preformed, single-use

ANKYLOS® - 07392532221200

Laboratory Analog one piece b/1.5/6.0 & b/3.0/6.0 straight
Dentsply Implants Manufacturing GmbH
31045170
In Commercial Distribution

  • 07392532221200 ()
31045170

  • Dental implant suprastructure, temporary, preformed, single-use

ANKYLOS® - 07392532221194

Laboratory Analog one piece 15° b/1.5/4.0 & b/3.0/4.0
Dentsply Implants Manufacturing GmbH
31045162
In Commercial Distribution

  • 07392532221194 ()
31045162

  • Dental implant suprastructure, temporary, preformed, single-use

ANKYLOS® - 07392532221187

Laboratory Analog one piece b/1.5/4.0 & b/3.0/4.0 straight
Dentsply Implants Manufacturing GmbH
31045160
In Commercial Distribution

  • 07392532221187 ()
31045160

  • Dental implant suprastructure, temporary, preformed, single-use

Lumipulse G B-Amyloid Controls (Plasma)-N - 04987270235485

Lumipulse G B-Amyloid Controls (Plasma)-N
FUJIREBIO INC.
235485
Not in Commercial Distribution

  • 04987270235485 ()

  • 4 bottles per unit; 1.0mLs per bottle


  • Tau protein IVD, kit, chemiluminescent immunoassay
  • Amyloid B component IVD, kit, chemiluminescent immunoassay

Lumipulse G B-Amyloid 1-42-N Plasma Calibrator - 04987270235454

Lumipulse G B-Amyloid 1-42-N Plasma Calibrator
FUJIREBIO INC.
235454
In Commercial Distribution

  • 04987270235454 ()

  • 4 Bottles per unit; 1.5mLs per bottle


  • Tau protein IVD, kit, chemiluminescent immunoassay
  • Amyloid B component IVD, kit, chemiluminescent immunoassay

Lumipulse G B-Amyloid 1-42-N Plasma - 04987270235447

Lumipulse G B-Amyloid 1-42-N Plasma IRC
FUJIREBIO INC.
235447
In Commercial Distribution

  • 04987270235447 ()

  • 42 Tests per Kit


  • Tau protein IVD, kit, chemiluminescent immunoassay
  • Amyloid B component IVD, kit, chemiluminescent immunoassay

DAAVLIN - 00850054882202

7 Series DT 311-12, 110-120V, 60Hz
DAAVLIN DISTRIBUTING CO., THE
7 Series
In Commercial Distribution

  • 00850054882202 ()


  • Ultraviolet phototherapy unit, professional

DAAVLIN - 00850054882165

4 Series DT 311-4, 120-240V, 50/60Hz
DAAVLIN DISTRIBUTING CO., THE
4 Series
In Commercial Distribution

  • 00850054882165 ()


  • Ultraviolet phototherapy unit, professional

DAAVLIN - 00850054882158

1 Series DT 311-4, 120-240V, 50/60Hz
DAAVLIN DISTRIBUTING CO., THE
1 Series
In Commercial Distribution

  • 00850054882158 ()


  • Ultraviolet phototherapy unit, professional

Panosol 6-3D - 00850054882134

UVB-612
DAAVLIN DISTRIBUTING CO., THE
Panosol 6-3D
In Commercial Distribution

  • 00850054882134 ()


  • Ultraviolet phototherapy unit, professional

Panosol 6-3D - 00850054882110

UVA-612
DAAVLIN DISTRIBUTING CO., THE
Panosol 6-3D
In Commercial Distribution

  • 00850054882110 ()


  • Ultraviolet phototherapy unit, professional

Panosol 6 - 00850054882097

UVB-640
DAAVLIN DISTRIBUTING CO., THE
Panosol 6
In Commercial Distribution

  • 00850054882097 ()


  • Ultraviolet phototherapy unit, professional

Panosol 6 - 00850054882080

UVA-660
DAAVLIN DISTRIBUTING CO., THE
Panosol 6
In Commercial Distribution

  • 00850054882080 ()


  • Ultraviolet phototherapy unit, professional

Panosol 6 - 00850054882073

UVA-640
DAAVLIN DISTRIBUTING CO., THE
Panosol 6
In Commercial Distribution

  • 00850054882073 ()


  • Ultraviolet phototherapy unit, professional
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