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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Aquasil® Ultra+ XLV Regular Set Small digit® 50 pack
DENTSPLY INTERNATIONAL INC.
678643
In Commercial Distribution

  • D0026786431 ()
  • D0026786430 ()

  • Total Volume: 1.6 Milliliter
  • 50 (1.6mL) Small Unit Doses, 50 Mix Tips, 50 Intraoral Tips
678643

  • Silicone dental impression material
Aquasil® Ultra+ LV Fast Set Small digit® 50 pack
DENTSPLY INTERNATIONAL INC.
678642
In Commercial Distribution

  • D0026786421 ()
  • D0026786420 ()

  • 50 (1.6mL) Small Unit Doses, 50 Mix Tips, 50 Intraoral Tips
  • Total Volume: 1.6 Milliliter
678642

  • Silicone dental impression material
Aquasil® Ultra+ LV Regular Set Large digit® 50 pack
DENTSPLY INTERNATIONAL INC.
678641
In Commercial Distribution

  • D0026786411 ()
  • D0026786410 ()

  • 50 (2.4mL) Large Unit Doses, 50 Mix Tips, 50 Intraoral Tips
  • Total Volume: 2.4 Milliliter
678641

  • Silicone dental impression material
Aquasil® Ultra+ LV Regular Set Small digit® 50 pack
DENTSPLY INTERNATIONAL INC.
678640
In Commercial Distribution

  • D0026786401 ()
  • D0026786400 ()

  • 50 (1.6mL) Small Unit Doses, 50 Mix Tips, 50 Intraoral Tips
  • Total Volume: 1.6 Milliliter
678640

  • Silicone dental impression material
SureFil® SDR® flow Posterior Bulk Fill Flowable Base Universal Syringe Sampler
DENTSPLY INTERNATIONAL INC.
61C004
Not in Commercial Distribution

  • D00261C0041 ()

  • 1 half-filled SureFil SDR Flow Universal syringe and 3 mix tips
  • Weight: 0.5 Gram
61C004

  • Dental composite resin
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Syringe. Italian..
SCIENTIFIC PHARMACEUTICALS, INC.
ID 65-024 I
In Commercial Distribution

  • D801ID65024I1 ()
65-024

  • Dentine adhesive
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix. Primer. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 65-021 I
In Commercial Distribution

  • D801ID65021I1 ()
65-021

  • Dentine adhesive
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. Spanish.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 65-02 S
In Commercial Distribution

  • D801SP6502S1 ()
65-02

  • Dentine adhesive
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. Non-Boxed.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 65-021 N
In Commercial Distribution

  • D801SP65021N1 ()
65-021

  • Dentine adhesive
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. Boxed.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 65-021 B
In Commercial Distribution

  • D801SP65021B1 ()
65-021

  • Dentine adhesive
Mixing tips 15 pcs. Mixing tips used for dispensing EZ PickUp material from auto mix cartridges.
STERNGOLD DENTAL LLC
220233
In Commercial Distribution

  • 00841549118210 ()


  • Dental material mixing nozzle
T-Saver Blue/Orange C&B Mix Tip, Bag of 25, 3.2 mm diameter, 57.6 mm length
BENCO DENTAL SUPPLY CO.
4898-908
In Commercial Distribution

  • 00366975025906 ()


  • Dental material mixing nozzle
Whip Mix Nasopharyngeal Swab is a 3D printed device designed to collect test samples from patient.
WHIP-MIX CORPORATION
70203
Not in Commercial Distribution

  • D040702031 ()
70203

  • Oral/upper respiratory tract specimen collection swab
3M™ ESPE™ Ketac™ Nano Light-Curing Glass Ionomer Quick Mix Restorative Trial Kit, 3305TK
3M COMPANY
3305TK
In Commercial Distribution

  • 50605861012077 ()
  • 30605861012073 ()
3305TK

  • Glass ionomer dental cement
"The MGB Alert Platinum Master Mix is intended for use in the development of laboratory assays which target DNA analytes using real-time PCR. The MGB Alert Platinum Master Mix itself generates no diagnostic information or data."
Elitechgroup Mdx LLC
M800694
In Commercial Distribution

  • 03661540951824 ()
M800694

  • Nucleic acid amplification mastermix kit IVD
The MGB Alert Platinum Master Mix is intended for use in the development of laboratory assays which target DNA analytes using real-time PCR. The MGB Alert Platinum Master Mix itself generates no diagnostic information or data.
Elitechgroup Mdx LLC
M800691
In Commercial Distribution

  • 03661540951800 ()
M800691

  • Nucleic acid amplification mastermix kit IVD
The MGB Alert Platinum Master Mix is intended for use in the development of laboratory assays which target DNA analytes using real-time PCR. The MGB Alert Platinum Master Mix itself generates no diagnostic information or data.
Elitechgroup Mdx LLC
M800599
In Commercial Distribution

  • 03661540950278 ()
M800599

  • Nucleic acid amplification mastermix kit IVD
The MGB Alert Platinum Master Mix is intended for use in the development of laboratory assays which target DNA analytes using real-time PCR. The MGB Alert Platinum Master Mix itself generates no diagnostic information or data.
Elitechgroup Mdx LLC
M800693
In Commercial Distribution

  • 03661540951817 ()
M800693

  • Nucleic acid amplification mastermix kit IVD
The MGB Alert Platinum Master Mix is intended for use in the development of laboratory assays which target DNA analytes using real-time PCR. The MGB Alert Platinum Master Mix itself generates no diagnostic information or data.
Elitechgroup Mdx LLC
M800599-am
In Commercial Distribution

  • 03661540951794 ()
M800599-am

  • Nucleic acid amplification mastermix kit IVD
This kit is used for extrusion of teeth. This is a chemical cure self mix kit containing 3 Oval Attachments with Chain and 2 Pad Attachments with Chain, Excel Regular Self Mix syringe and Assure Bonding Resin.
RELIANCE ORTHODONTIC PRODUCTS INC
CCCCK
Not in Commercial Distribution

  • D798CCCK0 ()
CCCCK

  • Dentine bonding agent/set
  • Orthodontic aligner auxiliary attachment kit
  • Orthodontic bracket adhesive
Pantos R 2.0 | C SC119_ Gun Green Havana Mix/Melanin AR Vintage Grey - B4.5 : 46 * 25 148
TAVAT EYEWEAR SRL
SC119_46GGR SV
In Commercial Distribution

  • 08053879821018 ()


  • Tinted non-prescription spectacles
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix. Trial Size. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 65-12
In Commercial Distribution

  • D801ID6512I1 ()
65-12

  • Dentine adhesive
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix. Paste / Liquid. Carpule.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 67-02
In Commercial Distribution

  • D801SP67021 ()
67-02

  • Dentine adhesive
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. Trial Syringe.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 65-12
In Commercial Distribution

  • D801SP65121 ()
65-12

  • Dentine adhesive
Mixing tips 50 pcs. Mixing tips used for dispensing Stern Vantage Impression Material from auto mix cartridges.
STERNGOLD DENTAL LLC
220162
In Commercial Distribution

  • 00841549115936 ()


  • Dental material mixing nozzle
3M™ ESPE™ Ketac™ Nano Light-Curing Glass Ionomer Quick Mix Capsule Shade A1 Refill, 3305A1
3M COMPANY
3305A1
In Commercial Distribution

  • 50605861012091 ()
  • 30605861012097 ()
  • 00605861012096 ()
3305A1

  • Glass ionomer dental cement
3M™ ESPE™ Ketac™ Nano Light-Curing Glass Ionomer Quick Mix Capsule Shade A4 Refill, 3305A4
3M COMPANY
3305A4
In Commercial Distribution

  • 50605861041435 ()
  • 30605861041431 ()
  • 00605861041430 ()
3305A4

  • Glass ionomer dental cement
3M™ ESPE™ Ketac™ Nano Light-Curing Glass Ionomer Quick Mix Capsule Shade A3, Sample, 3305A3-S
3M COMPANY
3305A3-S
In Commercial Distribution

  • 50605861039098 ()
  • 30605861039094 ()
  • 00605861039093 ()
3305A3-S

  • Glass ionomer dental cement
3M™ ESPE™ Ketac™ Nano Light-Curing Glass Ionomer Quick Mix Capsule Shade B2 Refill, 3305B2
3M COMPANY
3305B2
In Commercial Distribution

  • 50605861039074 ()
  • 30605861039070 ()
  • 00605861039079 ()
3305B2

  • Glass ionomer dental cement
3M™ ESPE™ Ketac™ Nano Light-Curing Glass Ionomer Quick Mix Capsule Shade A3.5 Refill, 3305A3.5
3M COMPANY
3305A3.5
In Commercial Distribution

  • 50605861039050 ()
  • 30605861039056 ()
  • 00605861039055 ()
3305A3.5

  • Glass ionomer dental cement
3M™ ESPE™ Ketac™ Nano Light-Curing Glass Ionomer Quick Mix Capsule Shade A3 Refill, 3305A3
3M COMPANY
3305A3
In Commercial Distribution

  • 50605861039036 ()
  • 30605861039032 ()
  • 00605861039031 ()
3305A3

  • Glass ionomer dental cement
3M™ ESPE™ Ketac™ Nano Light-Curing Glass Ionomer Quick Mix Capsule Shade A2 Refill, 3305A2
3M COMPANY
3305A2
In Commercial Distribution

  • 50605861039012 ()
  • 30605861039018 ()
  • 00605861039017 ()
3305A2

  • Glass ionomer dental cement
ORTHODONTIC GLITTER
LANG DENTAL MANUFACTURING CO., INC.
28 GRAMS SILVER MIX
In Commercial Distribution

  • D6502410SM0 ()
2410SM

  • Dental prosthesis restorative material, unfilled resin
No Description
Axiodent Inc.
25016 Manual Mix Pack
In Commercial Distribution

  • D161250160 ()


  • Calcium hydroxide dental cement
No Description
Axiodent Inc.
19020 Manual Mix Pack
In Commercial Distribution

  • D161190200 ()


  • Calcium hydroxide dental cement
No Description
Axiodent Inc.
19009 Manual Mix Pack
In Commercial Distribution

  • D161190090 ()


  • Calcium hydroxide dental cement
No Description
BURKHART DENTAL SUPPLY CO., THE
72720806
In Commercial Distribution

  • 00854212006981 ()
  • 00854212006974 ()


  • Dental material mixing nozzle
No Description
BIOMET
418300
In Commercial Distribution

  • 00880304371002 ()

  • 120G
418300

  • Orthopaedic cement preparation/delivery kit
No Description
BIOMET
418200
In Commercial Distribution

  • 00880304370999 ()

  • 80G
418200

  • Orthopaedic cement preparation/delivery kit
No Description
BIOMET
417300
In Commercial Distribution

  • 00880304370623 ()

  • 120G
417300

  • Orthopaedic cement preparation/delivery kit
No Description
BIOMET
417200
In Commercial Distribution

  • 00880304370609 ()

  • 80G
417200

  • Orthopaedic cement preparation/delivery kit
No Description
BIOMET
417100
In Commercial Distribution

  • 00880304370579 ()

  • 40G
417100

  • Orthopaedic cement preparation/delivery kit
Genotyping system for the detection of Factor II (Prothrombin) G20210A mutations.
AUTOGENOMICS, INC
01-3020-01
Not in Commercial Distribution

  • 00850009370068 ()
01-3020-01

  • Coagulation factor II (prothrombin) mutation IVD, kit, nucleic acid technique (NAT)
No Description
Lonza Verviers
BESP698P1/0.5
In Commercial Distribution

  • 05407010126976 ()
BESP698P1/0.5

  • Ex vivo cell culture medium
DSQ Alert™ HT HDV Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences within the Hepatitis Delta Virus RNA. The mix consists of a total of 7.8 nmol of DSQ probe per vial in a 1X TE buffer solution. The probe is labeled with the 6-FAM fluorophore and has an excitation wavelength maximum of 496 nm and an emission wavelength maximum of 517 nm. The reagent contained in this package should be protected from light and stored at less or equal to -10 degrees Celsius. The reagent must be used by the expiration date printed on the vial label. Product use is limited to five freeze-thaws.
Elitechgroup Mdx LLC
M800812
In Commercial Distribution

  • 03661540952814 ()
M800812

  • Hepatitis D virus nucleic acid IVD, kit, nucleic acid technique (NAT)
The MGB Alert PCR Master Mix package includes ready to use 2x master mix containing a non-Taq thermostable enzyme lacking exonuclease activity and provided in antibody inactivated form. An initial high-temperature incubation step denatures the antibodies to activate the enzyme. The master mix also includes Uracil-DNA Glycosylase (UDG) and dUTP to prevent carry-over contamination. MGB Alert PCR Enhancer and MGB Alert 25 mM MgCl2 are provided for additional flexibility in optimizing reaction conditions.
Elitechgroup Mdx LLC
M800331-am
In Commercial Distribution

  • 03661540950193 ()
M800331-am

  • Nucleic acid amplification mastermix kit IVD
MGB Alert® Pneumocystis Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences from Pneumocystis jirovecii. The mix consists of one probe at 0.56 nmol of probe per vial in a 1X TE buffer solution. The probe is labeled with 6-carboxyfluorescein and has an excitation wavelength maxima of 496 nm and an emission wavelength maxima of 517 nm.
Elitechgroup Mdx LLC
M800572
In Commercial Distribution

  • 03661540950049 ()
M800572

  • Pneumocystis jirovecii nucleic acid IVD, kit, nucleic acid technique (NAT)
DSQ Alert™ HT HDV Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences within the Hepatitis Delta Virus RNA. The mix consists of a total of 31.2 nmol of primers per vial in a 1X TE buffer solution. The primers target a 57 bp region of the Hepatitis Delta Virus RNA. The reagent contained in this package should be protected from light and stored at less or equal to -10 degrees Celsius. The reagent must be used by the expiration date printed on the vial label. Product use is limited to five freeze-thaws.
Elitechgroup Mdx LLC
M800811
In Commercial Distribution

  • 03661540952807 ()
m800811

  • Hepatitis D virus nucleic acid IVD, kit, nucleic acid technique (NAT)
MGB Alert® Pneumocystis Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from Pneumocystis jirovecii. The mix consists of a total of 3.5 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 156 bp nucleic acid sequence from the multi-copy mitochondrial large subunit rRNA (mtLSU) gene of Pneumocystis jirovecii.
Elitechgroup Mdx LLC
M800573
In Commercial Distribution

  • 03661540950056 ()
M800573

  • Pneumocystis jirovecii nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Sarstedt Aktiengesellschaft & Co.KG
65.716.399
In Commercial Distribution

  • 04038917925648 ()
  • 04038917925624 ()
65.716.399

  • Test tube/reservoir cap IVD
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