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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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METRON - 00885914022023

METRON CLEAR ULTRASOUND GEL, 5L
Performance Health Supply, LLC
922099
Not in Commercial Distribution

  • 10885914022020 ()
  • 00885914022023 ()

  • Total Volume: 5 Liter
922099

  • Skin topical coupling gel

METRON - 00885914004050

METRON ULTRASOUND GEL, 5L
Performance Health Supply, LLC
303001
In Commercial Distribution

  • 10885914004057 ()
  • 00885914004050 ()

  • Total Volume: 5 Liter
303001

  • Skin topical coupling gel

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

AQUASONIC CLEAR - 30855683006099

AQUASONC CLEAR 60G TUBE
PARKER LABORATORIES INC
ULTRASOUND GEL
In Commercial Distribution

  • 30855683006099 ()
  • 00855683006098 ()
03-02-1

  • Electrode conductive medium

AQUASONIC 100 - 30855683006044

AQUASONIC 100 ULTRASOUND TRANSMISSION GEL 0.25L
PARKER LABORATORIES INC
ULTRASOUND TRANSMISSION GEL
In Commercial Distribution

  • 30855683006044 ()
  • 00855683006043 ()
01-08-700189/40483A

  • Electrode conductive medium

AQUASONIC 100 - 30855683006037

AQUASONIC 100, 60G TUBE
PARKER LABORATORIES INC
ULTRASOUND TRANSMISSION GEL
In Commercial Distribution

  • 30855683006037 ()
  • 00855683006036 ()
01-02-1

  • Electrode conductive medium

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) - 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) - 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

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

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

VitaVitro - 06971982050410

No Description
SHENZHEN VITAVITRO BIOTECH CO.,LTD.
Culture Oil, Oil-1.0,500 ml
In Commercial Distribution

  • 06971982050410 ()
V009500

  • IVF medium

VitaVitro - 06971982050403

No Description
SHENZHEN VITAVITRO BIOTECH CO.,LTD.
Culture Oil, Oil-1.0,125ml
In Commercial Distribution

  • 06971982050403 ()
V009125

  • IVF medium

VitaVitro - 06971982050397

No Description
SHENZHEN VITAVITRO BIOTECH CO.,LTD.
Culture Oil, Oil-1.0, 60ml
In Commercial Distribution

  • 06971982050397 ()
V009060

  • IVF medium

Retractor - The University of Minnesota Retractor - 00083208130229

The University of Minnesota Retractor is used to hold mucoperiosteal flaps, cheeks, lips, and tongue away from the surgical area
Suncoast Dental, Inc
Retractor U of M
In Commercial Distribution

  • 00083208130229 ()
Retractor U of M

  • Hand-held dental retractor

syngo Application Software Media - 04056869025902

syngo Application Software VD1;syngo Application Software Media;Registered Medical Devices:syngo Application Software – GTIN 04056869012902
Siemens Healthcare GmbH
10849116
In Commercial Distribution

  • 04056869025902 ()


  • Basic diagnostic x-ray system application software

ProCHO5, Production media 10kg - 05407010125474

No Description
Lonza Verviers
BESP822X10
In Commercial Distribution

  • 05407010125474 ()
BESP822X10

  • Ex vivo cell culture medium

ProCHO5, Production media 1kg - 05407010125467

No Description
Lonza Verviers
BESP822X1
In Commercial Distribution

  • 05407010125467 ()
BESP822X1

  • Ex vivo cell culture medium

N/A - 00816576028108

Blood Agar 5% / CLED Agar with Bile, 15x100mm Biplate, 10ml/10ml. Hardy Diagnostics Blood Agar products are recommended for use as general purpose growth media for the isolation, cultivation, and differentiation of a wide variety of microorganisms. Hardy Diagnostics CLED Agar is recommended for the isolation, enumeration, and presumptive identification of urinary pathogens on the basis of lactose fermentation, while controlling the swarming of Proteus spp.
HARDY DIAGNOSTICS
J65
In Commercial Distribution

  • 00816576028092 ()
  • 00816576028108 ()
J65

  • Multiple formulation agar culture medium IVD

N/A - 00816576027224

Blood Agar 5% / Group A Beta Strep Agar, 15x100mm Biplate, 10ml/10ml. Hardy Diagnostics Blood Agar products are recommended for use as general purpose growth media for the isolation, cultivation, and differentiation of a wide variety of microorganisms. Hardy Diagnostics Group A Beta Strep Agar is an enriched media for the selective isolation of group A streptococci (Streptococcus pyogenes).
HARDY DIAGNOSTICS
J92
Not in Commercial Distribution

  • 00816576027217 ()
  • 00816576027224 ()
J92

  • Multiple formulation agar culture medium IVD

N/A - 00816576027187

Brucella Agar with Hemin and Vitamin K /LKV (Laked Blood Kanamycin Vancomycin) Agar Biplate, 15x100 biplate, 10/pk For the cultivation of anaerobic bacteria and the selective isolation of Bacteroides spp.
HARDY DIAGNOSTICS
J67
In Commercial Distribution

  • 00816576027170 ()
  • 00816576027187 ()
J87

  • Multiple formulation agar culture medium IVD

N/A - 00816576026753

Blood Agar / CLED Agar / MacConkey Agar, 15x100mm Triplate, 7ml/section. Hardy Diagnostics Blood Agar products are recommended for use as general purpose growth media for the isolation, cultivation, and differentiation of a wide variety of microorganisms. Hardy Diagnostics CLED Agar is recommended for the isolation, enumeration, and presumptive identification of urinary pathogens on the basis of lactose fermentation, while controlling the swarming of Proteus spp. Hardy Diagnostics MacConkey Agar is recommended for use as a selective and differential medium for the isolation of gram-negative bacilli (including coliform organisms and enteric pathogens), on the basis of lactose fermentation.
HARDY DIAGNOSTICS
J315
In Commercial Distribution

  • 00816576026746 ()
  • 00816576026753 ()
J315

  • Multiple formulation agar culture medium IVD

N/A - 00816576026739

Blood Agar 5% / Eosin Methylene Blue (EMB), Levine Agar, 15x100mm Biplate, 10ml/10ml. Hardy Diagnostics Blood Agar products are recommended for use as general purpose growth media for the isolation, cultivation, and differentiation of a wide variety of microorganisms. Hardy Diagnostics EMB Agar formulations are recommended for use as selective and differential media for the isolation of gram-negative bacilli (including coliform organisms and enteric pathogens) from clinical and nonclinical specimens.
HARDY DIAGNOSTICS
J22
In Commercial Distribution

  • 00816576026722 ()
  • 00816576026739 ()
J22

  • Multiple formulation agar culture medium IVD

N/A - 00816576026654

V Agar / Starch Agar with Bromcresol Purple, 15x100mm Biplate, 10ml/10ml. Hardy Diagnostics Starch Agar with Bromcresol Purple is recommended for use in the differentiation of Gardnerella vaginalis from genitourinary specimens. Hardy Diagnostics V Agar is an enriched media used for the isolation and differentiation of Gardnerella vaginalis.
HARDY DIAGNOSTICS
J181
Not in Commercial Distribution

  • 00816576026647 ()
  • 00816576026654 ()
J181

  • Multiple formulation agar culture medium IVD

N/A - 00816576026555

BluEcoli™ Urine Biplate, 15x100mm Biplate, 10ml/10ml. Hardy Diagnostics BluEcoli™ Urine Biplate is a urine culture media, consisting of Blood Agar on one side and BluEcoli™ Agar on the other side, which is used for the isolation of urinary pathogens and for the identification of E. coli.
HARDY DIAGNOSTICS
J123
In Commercial Distribution

  • 00816576026548 ()
  • 00816576026555 ()
J123

  • Multiple formulation agar culture medium IVD

HardyCHROM - 00816576026524

Blood Agar 5% / HardyCHROM™ UTI, 15x100mm Biplate, 10ml/10ml. Hardy Diagnostics Blood Agar products are recommended for use as general purpose growth media for the isolation, cultivation, and differentiation of a wide variety of microorganisms. HardyCHROM™ UTI is a non-selective chromogenic medium recommended for the cultivation, differentiation and enumeration of urinary tract pathogens based on colony color and morphology.
HARDY DIAGNOSTICS
J119
In Commercial Distribution

  • 00816576026517 ()
  • 00816576026524 ()
J119

  • Multiple formulation agar culture medium IVD

AnaeroGRO - 00816576024490

MultiPak B, BRU with Hemin and Vitamin K, Monoplate; LKV, Monoplate; PEA, Monoplate. Hardy Diagnostics AnaeroGRO™ Brucella Agar with Hemin and Vitamin K is recommended for use in the primary isolation, quantitation, and partial identification of obligately anaerobic microorganisms from clinical specimens. This non-selective medium is also suitable for the growth of aerobic and microaerophilic bacteria when incubated under the appropriate conditions.
HARDY DIAGNOSTICS
AG313
In Commercial Distribution

  • 00816576024490 ()
AG313

  • Enriched agar culture medium IVD
  • Differential/selective agar culture medium IVD

N/A - 00819398028431

PEA w/SB/Tergitol 7 Agar 15x100 biplate, 10 plates per pack Differentiation and isolation of gram-negative and gram-positive organisms (as well as fermenting characteristics), preventing of Proteus swarming, differentiation of gram-positive organisms, early detector of yeast (growth on both PEA & T7 with white colonies).
HARDY DIAGNOSTICS
J120
In Commercial Distribution

  • 00819398028028 ()
  • 00819398028431 ()
J120

  • Multiple formulation agar culture medium IVD
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