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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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SEPTODONT ADHERENCE REF SYR OPAQUE 4GM - 00303620000567

No Description
SEPTODONT, INC
01C2010
In Commercial Distribution

  • 00303620000567 ()

  • Weight: 4 Gram


  • Multi-purpose soft contact lens solution

SmartLite Focus - D010644500701

SmartLite Focus Charging Base is a part of the SmartLite Focus Curing Light and is available separately.
Dentsply De Trey GmbH
64450070
In Commercial Distribution

  • D010644500701 ()

  • Outer Diameter: 6.5 Centimeter
64450070

  • Dental/surgical polymerization lamp

Mixint Tip / Intraoral Tip - D01060620111

Mixing Tip/ Intraoral Tip is the mixing and application device to be applied with AH Plus Jet and is available seperately
Dentsply De Trey GmbH
60620116
In Commercial Distribution

  • D01060620110 ()
  • D01060620111 ()

  • Length: 5.2 Centimeter
60620116

  • Endodontic filling/sealing material

Tissue Goo™ Hemostatic Gel Big Shot Syringe Kit - 00359883005672

Gingival Retraction Solution
DEN-MAT HOLDINGS, LLC
641960
In Commercial Distribution

  • 00359883005672 ()

  • Total Volume: 60 Milliliter
641960

  • Gingival retraction solution

Auto-Cure Activator - 07290115052886

No Description
B.J.M. LABORATORIES LTD
100060
In Commercial Distribution

  • 07290115052886 ()

  • Total Volume: 10 Milliliter


  • Dentine bonding agent/set

Porcelain Etch - 07290115050479

No Description
B.J.M. LABORATORIES LTD
400082
In Commercial Distribution

  • 07290115050479 ()

  • Total Volume: 2.4 Milliliter


  • Dental prosthesis priming agent

Porcelain Silane - 07290115050462

No Description
B.J.M. LABORATORIES LTD
400083
In Commercial Distribution

  • 07290115050462 ()

  • Total Volume: 4 Milliliter


  • Dental prosthesis priming agent

Porcelain Fix - 07290115050448

Single package containing 2 syringes Porcelain Etch and 2 bottles Porcelain Silane
B.J.M. LABORATORIES LTD
400084
In Commercial Distribution

  • 07290115050448 ()

  • 2 Syringes 1.2ml (1.3g) Porcelain Etch, 2 Bottles 2ml (1.6g) Porcelain Silane


  • Dental prosthesis priming agent

High-Q-Bond Adhesive Resin Cement Automix - 07290115050370

No Description
B.J.M. LABORATORIES LTD
100050AM
In Commercial Distribution

  • 07290115050370 ()

  • Total Volume: 5 Milliliter


  • Dental composite resin

Multi Bond - 07290115050158

No Description
B.J.M. LABORATORIES LTD
100047
In Commercial Distribution

  • 07290115050158 ()

  • Total Volume: 2 Milliliter


  • Dentine bonding agent/set

Multi Bond - 07290115050141

No Description
B.J.M. LABORATORIES LTD
100046
In Commercial Distribution

  • 07290115050141 ()

  • Total Volume: 10 Milliliter


  • Dentine bonding agent/set

CARDINAL HEALTH - 20885380168557

DISPETTE 2 PLUGGED WESTERGREN
Cardinal Health 200, LLC
B4515-9
In Commercial Distribution

  • 50885380168558 ()
  • 20885380168557 ()
  • 10885380168550 ()
B4515-9

  • Erythrocyte sedimentation rate (ESR) IVD, kit

SNAP™ - 00810000528233

SNAP™ Intro Kit (1-Liquid & 4-Powders) with Russian Labeling (Kraftway)
PARKELL, INC.
S424-R
In Commercial Distribution

  • 00810000528233 ()
S424-R

  • Temporary dental crown/bridge resin

MucoHard™ - 00810000525690

MucoHard™+ Primer Refill
PARKELL, INC.
S642
In Commercial Distribution

  • 00810000525690 ()
S642

  • Denture reliner, hard

MucoHard™ - 00810000525683

MucoHard™+ Cartridge Refill
PARKELL, INC.
S641
In Commercial Distribution

  • 00810000525683 ()
S641

  • Denture reliner, hard

MucoHard™ - 00810000525676

MucoHard™+ Kit
PARKELL, INC.
S640
In Commercial Distribution

  • 00810000525676 ()
S640

  • Denture reliner, hard

E.T.C.™ - 00810000525331

E.T.C.™ Easy Temporary Cement
PARKELL, INC.
S255
In Commercial Distribution

  • 00810000525331 ()
S255

  • Dentine bonding agent/set

MucoHard™ - 00810000525270

MucoHard™ Hard Denture Reline Kit
PARKELL, INC.
S487
Not in Commercial Distribution

  • 00810000525270 ()
S487

  • Denture reliner, hard

MucoHard™ - 00810000525263

MucoHard™ Resin Refill Cartridge with Tips
PARKELL, INC.
S486
Not in Commercial Distribution

  • 00810000525263 ()
S486

  • Denture reliner, hard

MucoHard™ - 00810000525256

MucoHard™ Bonding Liner with 6-Brushes & 6-Pipettes
PARKELL, INC.
S485
Not in Commercial Distribution

  • 00810000525256 ()
S485

  • Denture reliner, hard

DuraFinish™ - 00810000525195

All-Cure DuraFinish™ Composite Glaze
PARKELL, INC.
S296
In Commercial Distribution

  • 00810000525195 ()
S296

  • Dental unfilled resin sealant/coating

DuraFinish™ - 00810000525188

DuraFinish™ Composite Glaze
PARKELL, INC.
S295
Not in Commercial Distribution

  • 00810000525188 ()
S295

  • Dental unfilled resin sealant/coating

Anti-Thyroglobulin (Anti-Tg) ELISA - 04048474041101

The Quantitative Determination of Thyroglobulin (Tg) Autoantibodies in Human Serum or Plasma by a Microplate Enzyme Immunoassay, Colorimetric.
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-4110
In Commercial Distribution

  • 04048474041101 ()
EIA-4110

  • Multiple thyroid antibody IVD, kit, enzyme immunoassay (EIA)

IMMULITE® Systems TG Recovery Sample Thyroglobulin - 00630414954523

Thyreoglobulin Recovery Sample - IMMULITE - CONS - 80 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381639
In Commercial Distribution

  • 00630414954523 ()
LTYRM

  • Thyroglobulin IVD, reagent

ELISA Tg IgG Smart Kit Test System - 00845533001182

The ZEUS ELISA Thyroglobulin (Tg) IgG Test System is intended for the qualitative and semi-quantitative detection of IgG-class antibody to thyroglobulin in human serum. The test system is intended to be used as an aid in the diagnosis of thyroid diseases. This test is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
SM2Z5061G
In Commercial Distribution

  • 00845533001182 ()
SM2Z5061G

  • Multiple thyroid antibody IVD, kit, enzyme immunoassay (EIA)

Tg AccuLite CLIA Test System - 192 Wells - 00816870023212

No Description
MONOBIND, INC.
2275-300
In Commercial Distribution

  • 00816870023212 ()

  • Width: 7.75 Inch
2275-300B

  • Thyroglobulin antibody IVD, kit, chemiluminescent immunoassay

Monobind AccuLite Tg CLIA Kit - 96 Wells - 00816870023205

No Description
MONOBIND, INC.
2275-300
In Commercial Distribution

  • 00816870023205 ()

  • Width: 7.75 Inch
2275-300A

  • Thyroglobulin IVD, kit, chemiluminescent immunoassay

Tg AccuBind ELISA Test System - 192 Wells - 00816870021775

No Description
MONOBIND, INC.
2225-300
In Commercial Distribution

  • 00816870021775 ()

  • Width: 7.75 Inch
2225-300B

  • Thyroglobulin antibody IVD, kit, enzyme immunoassay (EIA)

Tg AccuBind ELISA Test System - 96 Wells - 00816870021768

No Description
MONOBIND, INC.
2225-300
In Commercial Distribution

  • 00816870021768 ()

  • Width: 7.75 Inch
2225-300A

  • Thyroglobulin antibody IVD, kit, enzyme immunoassay (EIA)

Clear Horizon - 00866001000322

"24"" x 24"" SMS Eye Drape w/ 1 fluid control pouch & 4"" x 5"" w/ Incise"
AUSTIN MEDICAL
AU-1008S
In Commercial Distribution

  • 10866001000329 ()
  • 00866001000322 ()
AU-1008S

  • Patient surgical drape, single-use

Abena - 05703538923937

Abri -Soft Superdry holds 34 fluid ounces/1000 ml which measures which measures 24" x 24".
Abena North America, Inc
254119
In Commercial Distribution

  • 05703538923951 ()
  • 05703538923937 ()


  • Incontinence pants, single-use

Abena - 05703538923890

Abri -Soft Superdry Adult Incontinence holds 24 fluid ounces/700 ml which measures 16" x 24".
Abena North America, Inc
254115
In Commercial Distribution

  • 05703538923890 ()
  • 05703538923913 ()


  • Incontinence pants, single-use

StimChoice OTC Electrodes - 00092237622186

StimChoice OTC Electrodes, White Cloth, Square 24/pk Includes (24) 2" x 2" square snap electrodes
COMPASS HEALTH BRANDS CORP.
E202-24A
In Commercial Distribution

  • 80092237622182 ()
  • 00092237622186 ()
  • 30092237622187 ()
  • 01092237622185 ()


  • Transcutaneous electrical stimulation electrode, single-use

HALF APRON - 00840331244076

HALF APRON - Standard Size with Buckle Closure, .25mm Envirolite Size 6, 24"L X 24"W
BURLINGTON MEDICAL, LLC
UEHALF6B
In Commercial Distribution

  • 00840331244076 ()


  • Radiation shielding apron

HALF APRON - 00840331243932

HALF APRON - Standard Size with Buckle Closure, .35mm Envirolite Size 6, 24"L X 24"W
BURLINGTON MEDICAL, LLC
SEHALF6B
In Commercial Distribution

  • 00840331243932 ()


  • Radiation shielding apron

HALF APRON - 00840331243796

HALF APRON - Standard Size with Buckle Closure, .5mm Envirolite Size 6, 24"L X 24"W
BURLINGTON MEDICAL, LLC
REHALF6B
In Commercial Distribution

  • 00840331243796 ()


  • Radiation shielding apron

HALF APRON - 00840331251883

HALF APRON - Standard Size with Buckle Closure, .25mm Burlite Size 6, 24"L X 24"W
BURLINGTON MEDICAL, LLC
UBHALF1B
In Commercial Distribution

  • 00840331251883 ()


  • Radiation shielding apron

HALF APRON - 00840331251746

HALF APRON - Standard Size with Buckle Closure, .35mm Burlite Size 6, 24"L X 24"W
BURLINGTON MEDICAL, LLC
SBHALF1B
In Commercial Distribution

  • 00840331251746 ()


  • Radiation shielding apron

HALF APRON - 00840331251609

HALF APRON - Standard Size with Buckle Closure, .5mm Burlite Size 6, 24"L X 24"W
BURLINGTON MEDICAL, LLC
RBHALF1B
In Commercial Distribution

  • 00840331251609 ()


  • Radiation shielding apron

HALF APRON - 00840331281422

HALF APRON - Standard Size with Buckle Closure, .25mm Burlite Size 6, 24"L X 24"W
BURLINGTON MEDICAL, LLC
UBHALF6B
In Commercial Distribution

  • 00840331281422 ()


  • Radiation shielding apron

HALF APRON - 00840331281408

HALF APRON - Standard Size with Buckle Closure, .35mm Burlite Size 6, 24"L X 24"W
BURLINGTON MEDICAL, LLC
SBHALF6B
In Commercial Distribution

  • 00840331281408 ()


  • Radiation shielding apron

HALF APRON - 00840331281385

HALF APRON - Standard Size with Buckle Closure, .5mm Burlite Size 6, 24"L X 24"W
BURLINGTON MEDICAL, LLC
RBHALF6B
In Commercial Distribution

  • 00840331281385 ()


  • Radiation shielding apron

HALF APRON - 00840331258004

HALF APRON - Standard Size with Buckle Closure, .25mm Lead Size 6, 24"L X 24"W
BURLINGTON MEDICAL, LLC
ULHALF6B
In Commercial Distribution

  • 00840331258004 ()


  • Radiation shielding apron

HALF APRON - 00840331257861

HALF APRON - Standard Size with Buckle Closure, .35mm Lead Size 6, 24"L X 24"W
BURLINGTON MEDICAL, LLC
SLHALF6B
In Commercial Distribution

  • 00840331257861 ()


  • Radiation shielding apron

HALF APRON - 00840331257724

HALF APRON - Standard Size with Buckle Closure, .5mm Lead Size 6, 24"L X 24"W
BURLINGTON MEDICAL, LLC
RLHALF6B
In Commercial Distribution

  • 00840331257724 ()


  • Radiation shielding apron

Carnegie Surgical LLC - G1414045920

Spare lamp for conventional laryngoscope reusable blades, large (fits MAC 1-5, Flexible 2-4 & MIL 2-4 blades)
Carnegie Surgical LLC
404-592
In Commercial Distribution

  • G1414045920 ()
404-592

  • Laryngoscope blade, reusable

Epimed International, Inc. - 00818788021427

Tun-L--XL™/24 19g X 24" w/ R.K.™ 16 TW X 3.5" w/ plastic LOR
EPIMED INTERNATIONAL, INC
181-2542
In Commercial Distribution

  • 10818788021424 ()
  • 00818788021427 ()

  • Length: 3.5 Inch
  • Needle Gauge: 16 Gauge
  • Length: 24 Inch
  • Catheter Gauge: 3.2 French
  • 16g
  • 3.2Ch
  • 3.5in
  • 24in
181-2542

  • Epidural anaesthesia set, non-medicated

Detecto - 00809161137408

Bariatric Scale, Digital, 1000 lb x .2 lb / 450kg x .1 kg, 24" x 24" Platform
CARDINAL SCALE MANUFACTURING COMPANY
6856
In Commercial Distribution

  • 00809161137408 ()


  • Stand-on floor scale, electronic

Anti-Thyroglobulin (Anti-Tg) ELISA - 00840239041104

The Quantitative Determination of Thyroglobulin (Tg) Autoantibodies in Human Serum or Plasma by a Microplate Enzyme Immunoassay, Colorimetric. Measurements of Tg autoantibodies may aid in the diagnosis of certain thyroid diseases such as Hashimoto’s and Grave’s as well as nontoxic goiter.
DRG International Inc
EIA-4110
In Commercial Distribution

  • 00840239041104 ()

  • Total Volume: 20 Milliliter
  • Wash Solution
  • Calibrators
  • Total Volume: 13 Milliliter
  • Stop Solution
  • Total Volume: 1 Milliliter
  • Substrate B
  • Biotin Reagent
  • Substrate A
  • Total Volume: 7 Milliliter
  • Enzyme Reagent
  • Total Volume: 8 Milliliter
  • Serum Diluent
EIA-4110

  • Multiple thyroid antibody IVD, kit, enzyme immunoassay (EIA)

RINGLOC + INSTRUMENTATION - 05019279415328

No Description
Biomet Uk Ltd
31-400624
In Commercial Distribution

  • 05019279415328 ()

  • SIZE 24
31-400624

  • Orthopaedic implant impactor, reusable
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