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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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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

Biowave Noninvasive Electrodes - 00859911006089

Biowave Noninvasive Electrode - B-Set
BIOWAVE CORPORATION
MK78560 - BWEN01-B
In Commercial Distribution

  • 20859911006083 ()
  • 10859911006086 ()
  • 00859911006089 ()


  • Transcutaneous electrical stimulation electrode, single-use

Biowave Percutaneous Electrodes - 00859911006003

Biowave Percutaneous Electrode Set - B
BIOWAVE CORPORATION
MK78505 - BWEP01-B
In Commercial Distribution

  • 20859911006007 ()
  • 10859911006000 ()
  • 00859911006003 ()


  • Analgesic PENS system probe, single-use

SpO2.COM® pediatric SpO2 disposable sensor - 10843997000489

No Description
MASIMO CORPORATION
1775
In Commercial Distribution

  • 10843997000489 ()
  • 00843997000482 ()


  • Pulse oximeter probe, single-use

SpO2.COM® Infant SpO2 disposable sensor - 10843997000472

No Description
MASIMO CORPORATION
1777
In Commercial Distribution

  • 10843997000472 ()
  • 00843997000475 ()


  • Pulse oximeter probe, single-use

SpO2.COM® adult SpO2 disposable sensor - 10843997000465

No Description
MASIMO CORPORATION
1774
In Commercial Distribution

  • 10843997000465 ()
  • 00843997000468 ()


  • Pulse oximeter probe, single-use

SpO2.COM® NRC-SL2 Spacelabs Replacement Cable - 00843997001434

No Description
MASIMO CORPORATION
2335
In Commercial Distribution

  • 00843997001434 ()


  • Electrical-only medical device connection cable, reusable

SpO2.COM® NRC-P8 Patient Cable, 3M - 00843997001427

No Description
MASIMO CORPORATION
1949
In Commercial Distribution

  • 00843997001427 ()


  • Electrical-only medical device connection cable, reusable

SpO2.COM® NRC-SL Spacelabs Replacement Cable - 00843997001410

No Description
MASIMO CORPORATION
1900
In Commercial Distribution

  • 00843997001410 ()


  • Electrical-only medical device connection cable, reusable

ALBAclone Anti-A,B - 05060242471445

Blood Grouping Reagent, ALBAclone Anti-A,B (Murine Monoclonal IgM) for slide and tube techniques.
ALBA BIOSCIENCE LIMITED
Z023U
In Commercial Distribution

  • 05060242471445 ()
  • 05060242471278 ()
  • 05060242470882 ()


  • Anti-AB red blood cell grouping IVD, antibody

Streptex Latex B - 05056080501413

No Description
REMEL EUROPE LIMITED
R30950701
In Commercial Distribution

  • 05056080501413 ()


  • Beta-haemolytic Streptococcus serological grouping IVD, reagent

IDS-iSYS Diluent B - 05060169691100

No Description
IMMUNODIAGNOSTIC SYSTEMS LIMITED
IS-10DB
In Commercial Distribution

  • 05060169691100 ()


  • Immunohistochemistry antibody diluent IVD

MIX B Kit - 00858637005512

No Description
EXACT SCIENCES CORPORATION
100310
In Commercial Distribution

  • 00858637005512 ()


  • Nucleic acid amplification mastermix kit IVD

Chang Medium B - 00857515006108

CHANG Basal-450ml
FUJIFILM IRVINE SCIENTIFIC, INC.
C101-450mL
In Commercial Distribution

  • 00857515006108 ()

  • Total Volume: 450 Milliliter
C101

  • Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent

FMAT1 Prism B - 00867009000215

Disposable single use prism for FMAT1 Device
FALCK MEDICAL INC
Prism B
In Commercial Distribution

  • 00867009000215 ()
  • 10867009000212 ()
  • 20867009000219 ()

  • Length: 35 Centimeter


  • Ophthalmic tonometer tip cover

LIGHTSonic B UBM - 00853386006285

No Description
LIGHTMED USA INC
US0000
In Commercial Distribution

  • 00853386006285 ()


  • Ophthalmic ultrasound imaging system

B Medical Systems - 05450104551512

Ultra Low Freezer
B Medical Systems SARL
U201
In Commercial Distribution

  • 05450104551512 ()
991.8643.**

  • Ultralow-temperature laboratory freezer

B Medical Systems - 05450104548390

Pharmacy refrigerator/ freezer
B Medical Systems SARL
PF260
In Commercial Distribution

  • 05450104548390 ()
991.8346.**

  • Pharmacy refrigerator/freezer, mains-powered

B Medical Systems - 05450104548383

Laboratory refrigerator/ freezer
B Medical Systems SARL
LF260
In Commercial Distribution

  • 05450104548383 ()
991.8346.**

  • Laboratory refrigerator/freezer

B Medical Systems - 05450104548376

Blood refrigerator/ Plasma freezer
B Medical Systems SARL
BF261
In Commercial Distribution

  • 05450104548376 ()
991.8346.**

  • Blood refrigerator/freezer

B Medical Systems - 05450104548369

Pharmacy refrigerator
B Medical Systems SARL
P380
In Commercial Distribution

  • 05450104548369 ()
991.8336.**

  • Pharmacy refrigerator

B Medical Systems - 05450104548352

Laboratory refrigerator
B Medical Systems SARL
L380
In Commercial Distribution

  • 05450104548352 ()
991.8336.**

  • Laboratory refrigerator, basic

B Medical Systems - 05450104548338

Pharmacy refrigerator
B Medical Systems SARL
P290
In Commercial Distribution

  • 05450104548338 ()
991.8326.**

  • Pharmacy refrigerator

B Medical Systems - 05450104548314

Blood storage refrigerator
B Medical Systems SARL
B291
In Commercial Distribution

  • 05450104548314 ()
991.8326.**

  • Blood refrigerator

B Medical Systems - 05450104548307

Pharmacy refrigerator
B Medical Systems SARL
P130
In Commercial Distribution

  • 05450104548307 ()
991.8316.**

  • Pharmacy refrigerator

B Medical Systems - 05450104548291

Laboratory refrigerator
B Medical Systems SARL
L130
In Commercial Distribution

  • 05450104548291 ()
991.8316.**

  • Laboratory refrigerator, basic

B Medical Systems - 05450104548260

Laboratory refrigerator
B Medical Systems SARL
L55
In Commercial Distribution

  • 05450104548260 ()
991.8306.**

  • Laboratory refrigerator, basic

B Medical Systems - 05450104548246

Laboratory freezer
B Medical Systems SARL
F130
In Commercial Distribution

  • 05450104548246 ()
991.8706.**

  • Basic laboratory freezer

B Medical Systems - 05450104548239

Plasma storage freezer
B Medical Systems SARL
F131
In Commercial Distribution

  • 05450104548239 ()
991.8706.**

  • Blood plasma freezer
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