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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Mighty Mix; Hydrophilic Vinyl Polysiloxane Impression Material; 5:1 Cartridge System; Auto-Mix Putty
Kerr Corporation
Q34MB
In Commercial Distribution

  • 10814978022998 ()
  • 00814978022991 ()

  • Total Volume: 760 Milliliter


  • Silicone dental impression material
Mighty Mix; Hydrophilic Vinyl Polysiloxane Impression Material; 5:1 Cartridge System; Universal Body
Kerr Corporation
Q34MA
In Commercial Distribution

  • 10814978022981 ()
  • 00814978022984 ()

  • Total Volume: 760 Milliliter


  • Silicone dental impression material
T 80202 Hydrocolloid Probe Cover, Silver/Gold Mix, Heart, Large (1 1/4")
TARRY MEDICAL PRODUCTS, INC.
T 80202
Not in Commercial Distribution

  • 00810031980420 ()
  • 10810031980427 ()
T 80202 B50

  • Dressing-fixation skin adhesive tape, non-silicone
T 80202 Hydrocolloid Probe Cover, Silver/Gold Mix, Heart, Large (1 1/4")
TARRY MEDICAL PRODUCTS, INC.
T 80202
Not in Commercial Distribution

  • 00810031980420 ()
  • 20810031980424 ()
T 80202 B200

  • Dressing-fixation skin adhesive tape, non-silicone
Thyreoglobulin - IMMULITE - CONS - 3x2mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385247
In Commercial Distribution

  • 00630414978345 ()
LTYCM(D)

  • Thyroglobulin IVD, control
Thyreoglobulin - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381647
In Commercial Distribution

  • 00630414972084 ()
L2KTY2(D)

  • Thyroglobulin antibody IVD, kit, chemiluminescent immunoassay
2x60g cart.,12 mix&12 oral tips. Medium viscosity polyvinyl siloxane precision impression material.
STERNGOLD DENTAL LLC
220121
In Commercial Distribution

  • 00841549115929 ()


  • Silicone dental impression material
T-Saver Mix Tip Refills, Bag of 48, Yellow 4.2 mm diameter, 50.1 mm length
BENCO DENTAL SUPPLY CO.
4886-966
In Commercial Distribution

  • 00366975025890 ()


  • Dental material mixing nozzle
T-Saver Mix Tip Refills, Bag of 48, Pink 5.4 mm diameter, 59.4 mm length
BENCO DENTAL SUPPLY CO.
4886-957
In Commercial Distribution

  • 00366975025883 ()


  • Dental material mixing nozzle
Sensi Temp® Non-Eugenol Zinc Oxide Temporary Cement NEZO 5ml Syringe 10 Mix Tips
Sultan Healthcare Inc
70050
In Commercial Distribution

  • D687700501 ()

  • Total Volume: 5 Milliliter


  • Dental composite resin
Sensi Temp® Non-Eugenol Zinc Oxide Temporary Cement NEZO 25ml Cartridge 15 Mix Tips
Sultan Healthcare Inc
70055
In Commercial Distribution

  • D687700551 ()

  • Total Volume: 25 Milliliter


  • Dental composite resin
Cinch™ Platinum Medium Body In Split-Cartridge No Clog Auto Mix System (4-Cartridges & Tips)
PARKELL, INC.
S454S
Not in Commercial Distribution

  • M595S454S1 ()
  • M595S454S0 ()
S454S

  • Silicone dental impression material
CYP450 2C9 drug metabolizing enzyme and VKORC1 genotyping system
AUTOGENOMICS, INC
03-3140-01
Not in Commercial Distribution

  • 00850009370181 ()
03-3140-01

  • Anticoagulant-resistance multiple genetic risk factor IVD, kit, nucleic acid technique (NAT)
CYP2C19 drug metabolyzing enzyme genotyping system
AUTOGENOMICS, INC
03-3220-01
Not in Commercial Distribution

  • 00850009370150 ()
03-3220-01

  • Cytochrome P450 (CYP450) gene polymorphism IVD, kit, multiplex
No Description
OXOID LIMITED
SR0113E
In Commercial Distribution

  • 05032384011889 ()


  • Culture medium antimicrobial supplement IVD
No Description
BIOARRAY SOLUTIONS LTD
800-00193
In Commercial Distribution

  • 10888234100645 ()
800-00193

  • Multiple blood group genotyping IVD, reagent
No Description
Lonza Walkersville, Inc.
15-1007J
In Commercial Distribution

  • 00840075403197 ()
15-1007J

  • Ex vivo cell culture medium
No Description
Diamond Diagnostics Inc.
OY-MU8267D
In Commercial Distribution

  • 00811403017041 ()


  • Multiple clinical chemistry analyser IVD, laboratory
No Description
BISCO INC.
F-6102
Not in Commercial Distribution

  • D757F61020 ()

  • sixe text
F-6102

  • Dentine bonding agent/set
No Description
BISCO INC.
F-6100D
Not in Commercial Distribution

  • D757F6100D1 ()

  • sixe text
F-6100D

  • Dentine bonding agent/set
No Description
HYCOR BIOMEDICAL LLC
118877-001
In Commercial Distribution

  • 00816879023091 ()


  • General laboratory container, reusable
The Amplification Mix provides the reagent for the PCR amplification of the DNA sample as part of AvertD™, a prescription, qualitative genotyping test used to detect and identify 15 genetic polymorphisms in genomic DNA.
AUTOGENOMICS, INC
03-7560-01
In Commercial Distribution

  • 30850009370250 ()
  • 10850009370256 ()
03-7560-01

  • Opioid use disorder (OUD) genotyping IVD, kit, nucleic acid technique (NAT)
The PE Mix Reagent Module acts as a communication link with up to four reservoirs that house the test reagents as the Primer Extension Reaction is part of AvertD™, a prescription, qualitative genotyping test used to detect and identify 15 genetic polymorphisms in genomic DNA.
AUTOGENOMICS, INC
03-6560-01
In Commercial Distribution

  • 30850009370243 ()
  • 10850009370249 ()
03-6560-01

  • Opioid use disorder (OUD) genotyping IVD, kit, nucleic acid technique (NAT)
No Description
Sarstedt Aktiengesellschaft & Co.KG
72.737.992
In Commercial Distribution

  • 04038917195126 ()
  • 04038917120197 ()
72.737.992

  • Assay container IVD, single-use
Bone Cement Mixing and Delivery System
SUMMIT MEDICAL LIMITED
C703
In Commercial Distribution

  • 25060238200237 ()
  • 15060238200230 ()
  • 35060238200234 ()


  • Orthopaedic cement preparation/delivery kit
A radioimmunoassay for the quantitative or qualitative determination of antibodies to thyroglobulin(Tg) in human serum.
KRONUS, INC.
KR6275
In Commercial Distribution

  • B126KR62750 ()
KR6275

  • Thyroglobulin antibody IVD, kit, radioimmunoassay
A radioimmunoassay for the quantitative or qualitative determination of antibodies to thyroglobulin(Tg) in human serum.
KRONUS, INC.
KR6270
In Commercial Distribution

  • B126KR62700 ()
KR6270

  • Thyroglobulin antibody IVD, kit, radioimmunoassay
Mixing tips 50 pcs. Mixing tips used from an auto mix cartridge for Tempolok material.
STERNGOLD DENTAL LLC
220301
In Commercial Distribution

  • 00841549118494 ()


  • Dental material mixing nozzle
1x50ml cart.15 mix&15 oral tips. Self-curing, tissue colored silicone, a gingival reproduction material.
STERNGOLD DENTAL LLC
222025
In Commercial Distribution

  • 00841549118524 ()


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

  • D801SP65021 ()
65-02

  • Dentine adhesive
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