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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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GelShot - 10850958007647

RICHMAR WINNER EVO 10CM US ADAPTOR, Case of 10
COMPASS HEALTH BRANDS CORP.
GSA10RM1
Not in Commercial Distribution

  • 10850958007647 ()


  • Ultrasound coupling pad holder

GelShot - 10850958007159

CHATTANOOGA INTELECT ADVANCED, GENISYS, XT, OR INTELECT MOBILE, INTELECT TRANSPORT 2CM US ADAPTOR Case of 10
COMPASS HEALTH BRANDS CORP.
GSA2CH1
In Commercial Distribution

  • 10850958007159 ()


  • Ultrasound coupling pad holder

GelShot - 10850958007142

CHATTANOOGA INTELECT ADVANCED, GENISYS, XT, OR INTELECT MOBILE, INTELECT TRANSPORT 10CM US ADAPTOR Case of 10
COMPASS HEALTH BRANDS CORP.
GSA10CH1
Not in Commercial Distribution

  • 10850958007142 ()


  • Ultrasound coupling pad holder

GelShot - 10850958007135

DYNATRON SOLARIS PLUS 709 (D719), SOLARIS PLUS 708 (D718), AND DYNATRON 25 SERIES COMBO UNITS (D925B, D825B) 5CM US ADAPTOR, Case of 10
COMPASS HEALTH BRANDS CORP.
GSA5DY2
Not in Commercial Distribution

  • 10850958007135 ()


  • Ultrasound coupling pad holder

GelShot - 10850958007111

RICHMAR WINNER EVO 2CM US ADAPTOR, CASE OF 10
COMPASS HEALTH BRANDS CORP.
GSA2RM1
Not in Commercial Distribution

  • 10850958007111 ()


  • Ultrasound coupling pad holder

OVOIL HEAVY - 07350025910314

No Description
Vitrolife Sweden AB
10174
In Commercial Distribution

  • 07350025910314 ()


  • IVF medium

Kendall - 20884527017291

Ultrasound Gel Cube
Cardinal Health, Inc.
4061
Not in Commercial Distribution

  • 20884527017291 ()

  • Total Volume: 5 Liter


  • Skin topical coupling gel

Medichoice - 30885632133385

Gel Ultrasound Premium 20 Gram Non-Sterile Single Patient Packet Fragrance Free Clear Not Made With Natural Rubber Latex MediChoice
OWENS & MINOR DISTRIBUTION, INC.
30400400
In Commercial Distribution

  • 50885632133389 ()
  • 30885632133385 ()
  • 10885632133381 ()


  • Skin topical coupling gel

Kendall - 30884527017281

Ultrasound Gel Bottle
Cardinal Health, Inc.
4060
Not in Commercial Distribution

  • 20884527017284 ()
  • 30884527017281 ()

  • Total Volume: 250 Milliliter
4060

  • Skin topical coupling gel

Bausch + Lomb - 20757770057874

Independent Viewing Chamber
Bausch & Lomb Incorporated
IVC-12
In Commercial Distribution

  • 20757770057874 ()
  • 00757770057870 ()
IVC-12

  • Corneal resection holder, single-use

Stradis Medical, LLC. - M752HCT984910

Ultrasound Procedure Kit
STRADIS MEDICAL LLC
HCT9849-1
In Commercial Distribution

  • M752HCT984915 ()
  • M752HCT984910 ()


  • Topical coupling gel, sterile

Stradis Medical, LLC. - M752HCT98490

Ultrasound Procedure Kit
STRADIS MEDICAL, LLC
HCT9849
In Commercial Distribution

  • M752HCT98490 ()
  • M752HCT98495 ()


  • Topical coupling gel, sterile

Bausch + Lomb - 00757770059881

Independent Corneal Viewing Chamber (IVC-21)
Bausch & Lomb Incorporated
IVC-21
In Commercial Distribution

  • 00757770059881 ()
IVC-21

  • Corneal resection holder, single-use

GelShot - 20853904006296

METRON 5CM US ADAPTOR, Case of 10
COMPASS HEALTH BRANDS CORP.
GSA5MT1
Not in Commercial Distribution

  • 20853904006296 ()


  • Ultrasound coupling pad holder

PRAS Anaerobic Enrichment Broth (MTGE BROTH) - 00810048900572

AS-7785 Anaerobic Enrichment Broth (MTGE BROTH) is an enriched non-selective medium used for the cultivation of most anaerobic bacteria and other fastidious microorganisms. Pre-reduced anaerobically sterilized (PRAS). 500 mL fill volume. 500 mL Pyrex bottle. Transparent light yellow liquid. 1 bottle per pack.
ANAEROBE SYSTEMS
AS-7785
In Commercial Distribution

  • 00810048900572 ()
AS-7785

  • Enriched broth culture medium IVD

PRAS Anaerobic Enrichment Broth (MTGE BROTH) - 00810048900565

AS-7782 Anaerobic Enrichment Broth (MTGE BROTH) is an enriched non-selective medium used for the cultivation of most anaerobic bacteria and other fastidious microorganisms. Pre-reduced anaerobically sterilized. 250 mL fill volume. 250 mL Pyrex bottle. Transparent light yellow liquid. 1 bottle per pack.
ANAEROBE SYSTEMS
AS-7782
In Commercial Distribution

  • 00810048900565 ()
AS-7782

  • Enriched broth culture medium IVD

PRAS Anaerobic Enrichment Broth (MTGE BROTH) - 00810048900558

AS-778 Anaerobic Enrichment Broth (MTGE BROTH) is an enriched non-selective medium used for the cultivation of most anaerobic bacteria and other fastidious microorganisms. Pre-reduced anaerobically sterilized (PRAS). 6 mL fill volume. 16 x 100 mm hungate-capped tube. Transparent light yellow liquid. 10 tubes per pack.
ANAEROBE SYSTEMS
AS-778
In Commercial Distribution

  • 00810048901838 ()
  • 00810048900558 ()
AS-778

  • Enriched broth culture medium IVD

PRAS Anaerobic Enrichment Agar (MTGE) - 00810048900541

AS-777 Anaerobic Enrichment Agar (MTGE) is an enriched non-selective medium used for the cultivation of most anaerobic bacteria and other fastidious microorganisms. Pre-reduced anaerobically sterilized (PRAS). 100 x 15 mm agar plate. Transparent light yellow color. 4 plates per pack.
ANAEROBE SYSTEMS
AS-777
In Commercial Distribution

  • 00810048901821 ()
  • 00810048900541 ()
AS-777

  • Enriched agar culture medium IVD

PRAS Yeast Casitone Fatty Acids Broth w/ Carbohydrates (YCFAC BROTH) - 00810048900503

AS-6805 Yeast Casitone Fatty Acids Broth with Carbohydrates (YCFAC BROTH) is an enriched non-selective media for the cultivation of most anaerobic bacteria and other fastidious microorganisms, including Faecalibacterium prausnitzii. Pre-reduced anaerobically sterilized (PRAS). 500 mL fill volume. 500mL Pyrex bottle. Transparent dark yellow with slight precipitation. 1 bottle per pack.
ANAEROBE SYSTEMS
AS-6805
In Commercial Distribution

  • 00810048900503 ()
AS-6805

  • Enriched broth culture medium IVD

PRAS Yeast Casitone Fatty Acids Broth w/ Carbohydrates (YCFAC BROTH) - 00810048900497

AS-6802 Yeast Casitone Fatty Acids Broth with Carbohydrates (YCFAC BROTH) is an enriched non-selective media for the cultivation of most anaerobic bacteria and other fastidious microorganisms, including Faecalibacterium prausnitzii. Pre-reduced anaerobically sterilized (PRAS). 250 mL fill volume. 250mL Pyrex bottle. Transparent dark yellow liquid with slight precipitation. 1 bottle per pack.
ANAEROBE SYSTEMS
AS-6802
In Commercial Distribution

  • 00810048900497 ()
AS-6802

  • Enriched broth culture medium IVD

PRAS Yeast Casitone Fatty Acids Broth w/ Carbohydrates (YCFAC BROTH) - 00810048900480

AS-680 Yeast Casitone Fatty Acids Broth with Carbohydrates (YCFAC BROTH) is an enriched non-selective media for the cultivation of most anaerobic bacteria and other fastidious microorganisms, including Faecalibacterium prausnitzii. Pre-reduced anaerobically sterilized. 7 mL fill volume. 16 x 100 mm hungate-capped tube. Transparent light yellow with slight precipitation. 10 tubes per pack.
ANAEROBE SYSTEMS
AS-680
In Commercial Distribution

  • 00810048901814 ()
  • 00810048900480 ()
AS-680

  • Enriched broth culture medium IVD

PRAS Yeast Casitone Fatty Acid Agar w/ Carbohydrates (YCFAC) - 00810048900466

AS-675 Yeast Casitone Fatty Acids Agar with Carbohydrates (YCFAC) is an enriched non-selective media for the cultivation of most anaerobic bacteria and other fastidious microorganisms, including Faecalibacterium prausnitzii. Pre-reduced anaerobically sterilized (PRAS). 100 x 15 mm agar plate. Transparent light yellow. 4 plates per pack.
ANAEROBE SYSTEMS
AS-675
In Commercial Distribution

  • 00810048901791 ()
  • 00810048900466 ()
AS-675

  • Enriched agar culture medium IVD

PRAS Brain Heart Infusion Agar w/ Horse Blood & Taurocholate (BHIY-HT) - 00810048900435

AS-6463 Brain Heart Infusion Agar with Horse Blood and Taurocholate (BHIY-HT) is an enriched non-selective media for the germination and cultivation of Clostridioides difficile cells and spores along with other fastidious anaerobic microorganisms. Pre-reduced anaerobically sterilized (PRAS). 100 x 15 mm agar plate. Opaque burgundy red. 4 plates per pack.
ANAEROBE SYSTEMS
AS-6463
In Commercial Distribution

  • 00810048901760 ()
  • 00810048900435 ()
AS-6463

  • Enriched agar culture medium IVD

PRAS Oral Treponeme Enrichment Broth (OTEB) - 00810048900268

AS-6032 Oral Treponeme Enrichment Broth (OTEB) is an enriched non-selective medium used for the isolation, cultivation, and maintenance of Treponema spp. from clinical specimens. Pre-reduced anaerobically sterilized (PRAS). 250 mL fill volume. 250mL Pyrex bottle. Slightly turbid light yellow liquid. 1 bottle per pack.
ANAEROBE SYSTEMS
AS-6032
In Commercial Distribution

  • 00810048900268 ()
AS-6032

  • Enriched broth culture medium IVD

BD BBL™ Brain Heart Infusion Agar with 5% Sheep Blood Slants - 30382902971994

Tube BHI Ag Sl With 5% SB 10 Ea
BECTON, DICKINSON AND COMPANY
297199
Not in Commercial Distribution

  • 30382902971994 ()
  • 00382902971993 ()
297199

  • Enriched broth culture medium IVD

BD BBL™ Sabouraud Dextrose Agar, Emmons Mycoflask™ - 30382902963081

BD BBL™ Sabouraud Dextrose Agar, Emmons Mycoflask™
BECTON, DICKINSON AND COMPANY
296308
Not in Commercial Distribution

  • 30382902963081 ()
  • 00382902963080 ()
296308

  • Differential/selective agar culture medium IVD

BD BBL™ Brain Heart Infusion Agar with 5% Sheep Blood Slants - 30382902960677

BD BBL™ Brain Heart Infusion Agar with 5% Sheep Blood Slants
BECTON, DICKINSON AND COMPANY
296067
Not in Commercial Distribution

  • 30382902960677 ()
  • 00382902960676 ()
296067

  • Basic/simple nutrient agar culture medium IVD

BD BBL™ CTA Medium™ with Fructose - 30382902960011

BD BBL™ CTA Medium™ with Fructose
BECTON, DICKINSON AND COMPANY
296001
In Commercial Distribution

  • 30382902960011 ()
  • 00382902960010 ()
296001

  • Differential/selective broth culture medium IVD

BD BBL™ Cooked Meat Medium with Glucose, Hemin and Vitamin K1 - 30382902959824

BD BBL™ Cooked Meat Medium with Glucose, Hemin and Vitamin K1, Package of 10 size K tubes, 9 mL
BECTON, DICKINSON AND COMPANY
295982
In Commercial Distribution

  • 30382902959824 ()
  • 00382902959823 ()

  • Total Volume: 9 Milliliter
295982

  • Enriched broth culture medium IVD

BD BBL™ Potato Flakes Agar Slants with Chlor and Gent - 30382902922590

Tube Potato Flake Ag W/Chlor&Gent 100Ea
BECTON, DICKINSON AND COMPANY
292259
Not in Commercial Distribution

  • 30382902922590 ()
  • 00382902922599 ()
292259

  • Differential/selective agar culture medium IVD

BD BBL™ Cooked Meat Medium - 30382902215081

BD BBL™ Cooked Meat Medium, 8 mL, Carton of 100 size K tubes
BECTON, DICKINSON AND COMPANY
221508
In Commercial Distribution

  • 30382902215081 ()
  • 00382902215080 ()

  • Total Volume: 8 Milliliter
221508

  • Enriched broth culture medium IVD

BD BBL™ Lowenstein-Jensen Medium Slants - 30382902209097

BD BBL™ Lowenstein-Jensen Medium Slants, Carton of 100 size A tubes
BECTON, DICKINSON AND COMPANY
220909
In Commercial Distribution

  • 30382902209097 ()
  • 00382902209096 ()

  • Total Volume: 10 Milliliter
220909

  • Differential/selective agar culture medium IVD

BD BBL™ Lowenstein-Jensen Medium Slants - 30382902209080

BD BBL™ Lowenstein-Jensen Medium Slants, Package of 10 size A tubes
BECTON, DICKINSON AND COMPANY
220908
In Commercial Distribution

  • 30382902209080 ()
  • 00382902209089 ()

  • Total Volume: 10 Milliliter
220908

  • Differential/selective agar culture medium IVD

BD BBL™ Trichosel™ Broth, Modified, with 5% Horse Serum - 30382902983232

BD BBL™ Trichosel™ Broth, Modified, with 5% Horse Serum
BECTON, DICKINSON AND COMPANY
298323
In Commercial Distribution

  • 30382902983232 ()
  • 00382902983231 ()

  • Total Volume: 8 Milliliter
298323

  • Differential/selective broth culture medium IVD

BD BBL™ CTA Medium™ with Arabinose - 30382902977316

BD BBL™ CTA Medium™ with Arabinose
BECTON, DICKINSON AND COMPANY
297731
In Commercial Distribution

  • 30382902977316 ()
  • 00382902977315 ()
297731

  • Differential/selective broth culture medium IVD

BD BBL™ Sabouraud Brain Heart Infusion Agar Slants - 30382902976913

BD BBL™ Sabouraud Brain Heart Infusion Agar Slants, Ctn. of 100 size C tubes
BECTON, DICKINSON AND COMPANY
297691
In Commercial Distribution

  • 30382902976913 ()
  • 00382902976912 ()
297691

  • Differential/selective agar culture medium IVD

BD BBL™ Brucella Broth - 30382902961858

Tube Brucella Broth 5Ml 100 Ea
BECTON, DICKINSON AND COMPANY
296185
Not in Commercial Distribution

  • 30382902961858 ()
  • 00382902961857 ()
296185

  • Differential/selective agar culture medium IVD

BD BBL™ Sabouraud Dextrose Agar Deeps - 30382902961827

BD BBL™ Sabouraud Dextrose Agar Deeps, 20 mL, Carton of 100 size A tubes
BECTON, DICKINSON AND COMPANY
296182
In Commercial Distribution

  • 30382902961827 ()
  • 00382902961826 ()

  • Total Volume: 20 Milliliter
296182

  • Differential/selective agar culture medium IVD

BD BBL™ GN Broth - 30382902217306

BD BBL™ GN Broth, 8 mL
BECTON, DICKINSON AND COMPANY
221730
In Commercial Distribution

  • 30382902217306 ()
  • 00382902217305 ()

  • Total Volume: 8 Milliliter
221730

  • Enriched broth culture medium IVD

BD BBL™ GN Broth - 30382902217290

Tube Gn Broth 8Ml 10 Ea
BECTON, DICKINSON AND COMPANY
221729
Not in Commercial Distribution

  • 30382902217290 ()
  • 00382902217299 ()
221729

  • Differential/selective broth culture medium IVD

BD BBL™ CTA Medium™ with Xylose - 30382902216477

BD BBL™ CTA Medium™ with Xylose
BECTON, DICKINSON AND COMPANY
221647
Not in Commercial Distribution

  • 30382902216477 ()
  • 00382902216476 ()
221647

  • Differential/selective broth culture medium IVD

BD BBL™ Lowenstein-Jensen Medium Mycoflask™ - 30382902211168

Mycoflask Lowenstein Jensen Med 100 Ea
BECTON, DICKINSON AND COMPANY
221116
Not in Commercial Distribution

  • 30382902211168 ()
  • 00382902211167 ()
221116

  • Differential/selective agar culture medium IVD

McKesson - 20612479262106

UltraSound Gel Clear 20g pouch
MCKESSON MEDICAL-SURGICAL INC.
16-4960
In Commercial Distribution

  • 40612479262117 ()
  • 20612479262106 ()
  • 10612479262147 ()


  • Topical coupling gel, sterile

PRAS Oral Treponeme Enrichment Broth (OTEB) - 00810048900275

AS-6035 Oral Treponeme Enrichment Broth (OTEB) is an enriched non-selective medium used for the isolation, cultivation, and maintenance of Treponema spp. from clinical specimens. Pre-reduced anaerobically sterilized (PRAS). 500 mL fill volume. 500mL Pyrex bottle. Slightly turbid light yellow liquid. 1 bottle per pack.
ANAEROBE SYSTEMS
AS-6035
In Commercial Distribution

  • 00810048900275 ()
AS-6035

  • Enriched broth culture medium IVD

PRAS Oral Treponeme Enrichment Broth (OTEB) - 00810048900251

AS-603 Oral Treponeme Enrichment Broth (OTEB) is an enriched non-selective medium used for the isolation, cultivation, and maintenance of Treponema spp. from clinical specimens. Pre-reduced anaerobically sterilized (PRAS). 7 mL fill volume. 16 x 100 mm hungate-capped tube. Slightly turbid light yellow liquid. 10 tubes per pack.
ANAEROBE SYSTEMS
AS-603
In Commercial Distribution

  • 00810048901609 ()
  • 00810048900251 ()
AS-603

  • Enriched broth culture medium IVD

PRAS Enriched Tryptic Soy Agar (ETSA) - 00810048900237

AS-548 Enriched Tryptic Soy Agar (ETSA) is an enriched, non-selective, and differential medium intended for the isolation, quantitation, and partial identification of many fastidious and non-fastidious microorganisms. Pre-reduced anaerobically sterilized. 100 x 15 mm agar plate. Transparent yellow/red. 4 plates per pack.
ANAEROBE SYSTEMS
AS-548
In Commercial Distribution

  • 00810048901586 ()
  • 00810048900237 ()
AS-548

  • Enriched agar culture medium IVD

PRAS Chocolate Agar (CHOC) - 00810048900169

AS-244 Chocolate Agar (CHOC) is an enriched non-selective agar media recommended for use in the isolation and cultivation of fastidious aerobic and anaerobic organisms. Pre-reduced anaerobically sterilized (PRAS). 100 x 15 mm agar plate. Opaque milk chocolate color. 4 plates per pack.
ANAEROBE SYSTEMS
AS-244
In Commercial Distribution

  • 00810048901555 ()
  • 00810048900169 ()
AS-244

  • Enriched agar culture medium IVD

PRAS Chocolate Agar (CHOC) - 00810048900152

AS-214 Chocolate Agar (CHOC) is an enriched non-selective agar media recommended for use in the isolation and cultivation of fastidious aerobic and anaerobic organisms. Pre-reduced anaerobically sterilized (PRAS). 100 x 15 mm agar plate. Opaque milk chocolate color. 1 plate per pack.
ANAEROBE SYSTEMS
AS-214
In Commercial Distribution

  • 00810048900152 ()
AS-214

  • Enriched agar culture medium IVD

CaseBioscience® - 07540161790042

CaseBioscience® PBS1X-Dulbecco's Phosphate Buffered Saline Solution 500 mL
CaseBioscience Inc
APBS-500
In Commercial Distribution

  • 07540161790042 ()

  • Total Volume: 500 Milliliter
APBS-500

  • IVF medium

ManaMed Inc - 00810113688473

This Ultrasound Coupling Gel is to be used with our ManaSport+ product or any other Ultrasound devices or non-adhesive electrodes. This allows the wave pattern to transmit through the skin into the treatment site.
Manamed, Inc.
ManaMed Ultrasound Coupling Gel
In Commercial Distribution

  • 00810113688473 ()
MANAGEL01

  • Skin topical coupling gel
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