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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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
DETAX GmbH
03913
In Commercial Distribution

  • EDET039131 ()


  • Earmould impression material
No Description
SEPTODONT, INC
FP-NOVOINC-054
In Commercial Distribution

  • 07540187001061 ()


  • Orthodontic bracket adhesive
Silcone Dental Impression Material
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
275380
In Commercial Distribution

  • 07540172008105 ()

  • cartridge
  • Total Volume: 380 Milliliter
275380

  • Silicone dental impression material
No Description
BURKHART DENTAL SUPPLY CO., THE
72720802
In Commercial Distribution

  • 00815878022067 ()


  • Dental material mixing nozzle
No Description
BURKHART DENTAL SUPPLY CO., THE
72720801
In Commercial Distribution

  • 00815878022050 ()


  • Dental material mixing nozzle
No Description
BURKHART DENTAL SUPPLY CO., THE
72720800
In Commercial Distribution

  • 00815878022043 ()


  • Dental material mixing nozzle
No Description
BISCO INC.
F-6101
Not in Commercial Distribution

  • D757F61010 ()

  • sixe text
F-6101

  • Dentine bonding agent/set
No Description
BISCO INC.
F-6102D
Not in Commercial Distribution

  • D757F6102D1 ()

  • sixe text
F-6102D

  • Dentine bonding agent/set
No Description
BISCO INC.
F-6101D
Not in Commercial Distribution

  • D757F6101D1 ()

  • sixe text
F-6101D

  • Dentine bonding agent/set
No Description
Lonza Walkersville, Inc.
15-1007XS
In Commercial Distribution

  • 00840075404071 ()
15-1007XS

  • Cell culture medium IVD
No Description
Lonza Walkersville, Inc.
15-1007I
In Commercial Distribution

  • 00840075403180 ()
15-1007I

  • Ex vivo cell culture medium
Blister Support Bandage Cushion
HRA PHARMA AMERICA, INC.
00810000310036
In Commercial Distribution

  • 00810000310036 ()


  • Adhesive bandage
No Description
PEARSON DENTAL SUPPLIES, INC.
D440752
In Commercial Distribution

  • D724D4407521 ()


  • Orthodontic bracket adhesive
600ml
PEARSON DENTAL SUPPLIES, INC.
D010426
In Commercial Distribution

  • D724D0104260 ()


  • Polysulfide dental impression material
600ml
PEARSON DENTAL SUPPLIES, INC.
D010400
In Commercial Distribution

  • D724D0104000 ()


  • Polysulfide dental impression material
This kit is used for extrusion of teeth. This is a chemical cure self mix kit containing 3 Disposable Oval Attachments with Chain and 2 Disposable Pad Attachments with Chain, Excel Regular Self Mix syringe and Assure Bonding Resin.
RELIANCE ORTHODONTIC PRODUCTS INC
DCCCCK
Not in Commercial Distribution

  • D798DCCCCK0 ()
DCCCCK

  • Dentine bonding agent/set
  • Orthodontic aligner auxiliary attachment kit
  • Orthodontic bracket adhesive
Contains 1 Montage Flowable Cartridge 00850391007290 1 Montage Flowable Dispenser 00850391007306 3 Montage Flowable Static Mix Tips 00850391007313
ABYRX, INC.
MON-BVF-1501FL
In Commercial Distribution

  • 00850391007320 ()


  • Synthetic bone graft
  • Bone matrix implant, synthetic, non-antimicrobial
Whip Mix VeriGuide™ OS is a 3D printed resin for producing drilling guides used in dental surgery.
WHIP-MIX CORPORATION
71175
In Commercial Distribution

  • D040711751 ()
71175

  • Custom-made orthopaedic/craniofacial surgical guide
50 mL automix cartridge + 30 mix tips -Multi-purpose core and tooth build up resin- dual cure, fluoride releasing
PULPDENT CORPORATION
SBU50
In Commercial Distribution

  • D701SBU502 ()

  • Total Volume: 50 Milliliter


  • Dental composite resin
25 mL automix cartridge + 20 mix tips -Multi-purpose core and tooth build up resin- dual cure, fluoride releasing
PULPDENT CORPORATION
SBU
In Commercial Distribution

  • D701SBU2 ()

  • Total Volume: 25 Milliliter


  • Dental composite resin
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix. Paste / Liquid. Syringe. Non-Boxed.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 66-02
In Commercial Distribution

  • D801SP66021 ()
66-02

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

  • D801SP6512S1 ()
65-12

  • Dentine adhesive
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. Activator / Primer. Non-Boxed.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 65-121 N
In Commercial Distribution

  • D801SP65121N1 ()
65-121

  • Dentine adhesive
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. Activator / Primer. Boxed.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 65-121 B
In Commercial Distribution

  • D801SP65121B1 ()
65-121

  • Dentine adhesive
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. Part B. Carpule.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 65-028 C
In Commercial Distribution

  • D801SP65028C1 ()
65-028

  • Dentine adhesive
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. Part B. Boxed.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 65-024 B
In Commercial Distribution

  • D801SP65024B1 ()
65-024

  • Dentine adhesive
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. Part B. Non-Boxed.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 65-024
In Commercial Distribution

  • D801SP650241 ()
65-024

  • Dentine adhesive
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. Part B. Boxed.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 65-022 B
In Commercial Distribution

  • D801SP65022B1 ()
65-022

  • Dentine adhesive
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. Part B. Boxed.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 65-022
In Commercial Distribution

  • D801SP650221 ()
65-022

  • Dentine adhesive
Aquasil Ultra+ Tray Material Hand Mix Soft Putty Regular Set (Orange) with 50mL LV Regular Set Wash Material
DENTSPLY INTERNATIONAL INC.
678712
Not in Commercial Distribution

  • D0026787121 ()
678712

  • Silicone dental impression material
Aquasil Ultra+ Tray Material Hand Mix Soft Putty Regular Set (Teal) with 50mL XLV Regular Set Wash Material
DENTSPLY INTERNATIONAL INC.
678711
Not in Commercial Distribution

  • D0026787111 ()
678711

  • Silicone dental impression material
Self Mixing Tips are intended for use in the mix / delivery of two part adhesives/cements. Qty 15
RELIANCE ORTHODONTIC PRODUCTS INC
SMT
In Commercial Distribution

  • D798SMT1 ()
  • D798SMT0 ()
SMT

  • Dental material injection cannula, single-use
3M™ ESPE™ Ketac™ Nano Light-Curing Glass Ionomer Quick Mix Capsule Shade A1 Sample Kit, 3305A1-S
3M COMPANY
3305A1-S
Not in Commercial Distribution

  • 50605861005451 ()
  • 30605861005457 ()
  • 00605861005456 ()
3305A1-S

  • Glass ionomer dental cement
A device used to mix the powder and liquid in application capsules intended for use in dental treatments.
E.M.S. Electro Medical Systems (Hangzhou)Co.,Ltd.
A
In Commercial Distribution

  • 06971503860788 ()
Y200F6D490 9050

  • Dental amalgam mixer
The MGB Alert One-Step Reverse Transcriptase PCR Master Mix package includes a 2X master mix containing a thermostable polymerase with exonuclease activity and provided in hot-start format. Included are 100X reverse transcriptase, 50X RNase inhibitor, and RNase-free water in separate tubes.
Elitechgroup Mdx LLC
M800689
In Commercial Distribution

  • 03661540951756 ()
M800689

  • Nucleic acid amplification mastermix kit IVD
oncoReveal CDx Box 2 of 4. This box contains all of the indexing primers and indexing PCR master mix.
Pillar Biosciences, Inc.
HDA-LC-2001-48-2
In Commercial Distribution

  • 00860001218237 ()
HDA-LC-2001-48-2

  • Colorectal cancer genotyping IVD, kit, nucleic acid technique (NAT)
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix. Paste / Liquid. Syringe. Non-Boxed. Spanish.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 66-02 S
In Commercial Distribution

  • D801SP6602S1 ()
66-02

  • Dentine adhesive
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix. Paste / Liquid. Syringe. Non-Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 66-02 I
In Commercial Distribution

  • D801ID6602I1 ()
66-02

  • Dentine adhesive
No Description
Dentsply International Inc.
644432
In Commercial Distribution

  • D0016444321 ()
644432

  • Solution agitator
  • Root canal ultrasonic irrigation handpiece tip
  • Medical equipment/instrument drape, single-use
No Description
Dentsply International Inc.
644431
In Commercial Distribution

  • D0016444311 ()
644431

  • Medical equipment/instrument drape, single-use
  • Root canal ultrasonic irrigation handpiece tip
  • Solution agitator
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. Activator / Primer Plastic Bottle. Boxed.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 65-126 B
In Commercial Distribution

  • D801SP65126B1 ()
65-126

  • Dentine adhesive
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. Activator / Primer Plastic Bottle. Non-Boxed.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 65-126
In Commercial Distribution

  • D801SP651261 ()
65-126

  • Dentine adhesive
No Description
Lonza Verviers
BESP698P20S
In Commercial Distribution

  • 05407010126983 ()
BESP698P20S

  • Ex vivo cell culture medium
No Description
Lonza Verviers
BESP808X10
Not in Commercial Distribution

  • 05407010124507 ()
BESP808X10

  • Ex vivo cell culture medium
No Description
Lonza Verviers
BESP808X5
In Commercial Distribution

  • 05407010121612 ()
BESP808X5

  • Ex vivo cell culture medium
No Description
Lonza Verviers
BESP808X0.365
In Commercial Distribution

  • 05407010121605 ()
BESP808X0.365

  • Ex vivo cell culture medium
No Description
Lonza Verviers
BESP808J
In Commercial Distribution

  • 05407010121599 ()
BESP808J

  • Ex vivo cell culture medium
No Description
Lonza Verviers
BESP808D
In Commercial Distribution

  • 05407010121582 ()
BESP808D

  • Ex vivo cell culture medium
No Description
Lonza Verviers
BESP808B1
In Commercial Distribution

  • 05407010121575 ()
BESP808B1

  • Ex vivo cell culture medium
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