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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Symmetry® Tuning Fork, C-1024 w/o Weights, Aluminum Alloy
SYMMETRY SURGICAL INC.
62-0713
In Commercial Distribution

  • 00887482116623 ()


  • Tuning fork
Symmetry® Tuning Fork, C-512 w/o Weights, Aluminum Alloy
SYMMETRY SURGICAL INC.
62-0712
In Commercial Distribution

  • 00887482116616 ()
62-0712

  • Tuning fork
Symmetry® Tuning Fork, C-256 w/Weights, Aluminum Alloy
SYMMETRY SURGICAL INC.
62-0711
In Commercial Distribution

  • 00887482116609 ()
62-0711

  • Tuning fork
Symmetry® Tuning Fork, C-128 w/Weights, Aluminum Alloy
SYMMETRY SURGICAL INC.
62-0710
In Commercial Distribution

  • 00887482116593 ()
62-0710

  • Tuning fork
1024Hz Frequency Tuning Fork
RASHMAN CORPORATION
C-1024
In Commercial Distribution

  • 00786511010249 ()


  • Tuning fork
512Hz Frequency Tuning Fork
RASHMAN CORPORATION
C-512
In Commercial Distribution

  • 00786511005122 ()


  • Tuning fork
256Hz Frequency Tuning Fork with Weights
RASHMAN CORPORATION
C-256
In Commercial Distribution

  • 00786511002565 ()


  • Tuning fork
128Hz Frequency Tuning Fork with Weights
RASHMAN CORPORATION
C-128
In Commercial Distribution

  • 00786511001285 ()


  • Tuning fork
U OF U LVAD DRESSING SYSTEM
CENTURION MEDICAL PRODUCTS CORPORATION
DM535
In Commercial Distribution

  • 00653160286434 ()
  • 10653160286431 ()
DM535

  • General surgical procedure kit, medicated
INMOVILIZADOR DE DEDO PULGAR- U U
PANTYMED S.A.
1102-6020 U U
In Commercial Distribution

  • 07798094547930 ()


  • Wrist immobilizer, reusable
No Description
BIOARRAY SOLUTIONS LTD
800-20202-08
In Commercial Distribution

  • 10888234100065 ()
800-20202-08

  • Multiple blood group genotyping IVD, nucleic acid technique (NAT)
No Description
BIOARRAY SOLUTIONS LTD
800-20236
In Commercial Distribution

  • 10888234102632 ()
800-20236

  • Multiple blood group genotyping IVD, control
No Description
BIOARRAY SOLUTIONS LTD
800-20202-96
In Commercial Distribution

  • 10888234102618 ()
800-20202-96

  • Multiple blood group genotyping IVD, nucleic acid technique (NAT)
No Description
BIOARRAY SOLUTIONS LTD
800-00229
In Commercial Distribution

  • 10888234102328 ()
800-00229

  • Multiple blood group genotyping IVD, control
No Description
BIOARRAY SOLUTIONS LTD
800-00228
In Commercial Distribution

  • 10888234102298 ()
800-00228

  • Multiple blood group genotyping IVD, control
Hemo-QC simulates blood samples and is intended for the daily quality control of routine blood bank reagents used in manual, semi-automated and automated blood typing and antibody screen test systems.
HEMO BIOSCIENCE INC
H9200
In Commercial Distribution

  • 00858352006009 ()
H9200

  • Multiple blood group genotyping IVD, control
The ID CORE CONTROL kit consists of 2 sets of recombinant synthetic DNA plasmids to be used as positive controls to evaluate the performance of the ID CORE XT test(Kit Product Number: 1021720000). The ID CORE CONTROL kit contains two separate vials: ID CORE CONTROL 1 and ID CORE CONTROL 2, both composed of synthetic plasmid pools to be used as assayed positive controls for alternate alleles (alleles 1 and 2, respectively) of the 29 polymorphisms assayed by ID CORE XT. Both control vials must be used in every run of the ID CORE XT test as positive controls for the correct detection of the polymorphism genotypes interrogated by the test. Each control has expected polymorphism genotypes results in the ID CORE XT test when analyzed by the ID CORE XT ANALYSIS SOFTWARE and will produce a valid or invalid run result. ID CORE XT is a qualitative, polymerase chain reaction (PCR) and hybridization-based genotyping test for the simultaneous identification of multiple alleles encoding human erythrocyte antigens (HEAs) in human genomic DNA. ID CORE XT interrogates 29 polymorphisms to predict 53 HEA allele genotypes and 37 antigen phenotypes of the following blood group systems: Rh, Kell, Kidd, Duffy, MNS, Diego, Dombrock, Colton, Cartwright and Lutheran, as an alternative to serology.
PROGENIKA BIOPHARMA, SA
v1
In Commercial Distribution

  • 08437013457040 ()
1301790000

  • Multiple blood group genotyping IVD, control
ID CORE XT (Reagents and Analysis Software) is a qualitative, polymerase chain reaction (PCR) and hybridization-based genotyping test for the simultaneous identification of multiple alleles encoding human erythrocyte antigens (HEAs) in genomic DNA extracted from whole blood specimens collected in EDTA. This test can be used to genotype 29 polymorphisms and predict 37 HEA phenotypes of blood group systems Rh (CW, C, c, E, e, VS, V, hrB, hrS), Kell (K, k, Kpa, Kpb, Jsa, Jsb), Kidd (Jka, Jkb), Duffy (Fya, Fyb), MNS (M, N, S, s, U, Mia), Diego (Dia, Dib), Dombrock (Doa, Dob, Hy, Joa), Colton (Coa, Cob), Cartwright (Yta, Ytb), and Lutheran (Lua, Lub) as an alternative to serology. The ID CORE XT test relies on allele-specific probes attached to color-coded microspheres, which hybridize specifically to the labeled PCR products. A subsequent fluorescent labeling step allows detection and quantification of the hybridization signal. ID CORE XT generates a simultaneous multiplex reaction in a single well, avoiding the need to run separate methods in parallel. The software outcome is a polymorphism genotype, a predicted allele genotype and a predicted phenotype, bypassing any subjective interpretation of the results.
PROGENIKA BIOPHARMA, SA
v3
In Commercial Distribution

  • 08437013457019 ()
1021720000

  • Multiple blood group genotyping IVD, nucleic acid technique (NAT)
U Drape
O&M HALYARD, INC.
48098
In Commercial Distribution

  • 30680651480980 ()
  • 20680651480983 ()
  • 90680651480982 ()
48098

  • Patient surgical drape, single-use, non-sterile
U BAR
MEDLINE INDUSTRIES, INC.
DYNJ908421C
In Commercial Distribution

  • 10198459320484 ()
DYNJ908421C

  • General surgical procedure kit, non-medicated, single-use
Syringe U
TOKUYAMA DENTAL CORPORATION
12715
In Commercial Distribution

  • 04548190127153 ()


  • Dental composite resin
PLT U
TOKUYAMA DENTAL CORPORATION
12735
In Commercial Distribution

  • 04548190127351 ()
  • 94548190127354 ()


  • Dental composite resin
U Pin
Rti Surgical, Inc.
999001
In Commercial Distribution

  • 00191083044460 ()
999001

  • General internal orthopaedic fixation system implantation kit
"U" extractor
CORIN LTD
MDE023
In Commercial Distribution

  • 05056139214912 ()
MDE023

  • Orthopaedic prosthesis implantation positioning instrument, reusable
U BAR
MEDLINE INDUSTRIES, INC.
DYNJ902374D
In Commercial Distribution

  • 10889942759378 ()
DYNJ902374D

  • General surgical procedure kit, non-medicated, single-use
U BAR
MEDLINE INDUSTRIES, INC.
DYNJ902374G
In Commercial Distribution

  • 40193489931939 ()
  • 10193489931938 ()
DYNJ902374G

  • General surgical procedure kit, non-medicated, single-use
U BAR
MEDLINE INDUSTRIES, INC.
DYNJ908421A
In Commercial Distribution

  • 10195327191207 ()
DYNJ908421A

  • General surgical procedure kit, non-medicated, single-use
U BAR
MEDLINE INDUSTRIES, INC.
DYNJ902374I
In Commercial Distribution

  • 40193489977920 ()
  • 10193489977929 ()
DYNJ902374I

  • General surgical procedure kit, non-medicated, single-use
U BAR
MEDLINE INDUSTRIES, INC.
DYNJ902374C
In Commercial Distribution

  • 10889942530533 ()
DYNJ902374C

  • General surgical procedure kit, non-medicated, reusable
U BAR
MEDLINE INDUSTRIES, INC.
DYNJ908421
In Commercial Distribution

  • 10195327074081 ()
DYNJ908421

  • General surgical procedure kit, non-medicated, single-use
U BAR
MEDLINE INDUSTRIES, INC.
DYNJ902374J
In Commercial Distribution

  • 40195327223954 ()
  • 10195327223953 ()
DYNJ902374J

  • General surgical procedure kit, non-medicated, single-use
U BAR
MEDLINE INDUSTRIES, INC.
DYNJ901408D
In Commercial Distribution

  • 10889942236633 ()
DYNJ901408D

  • General surgical procedure kit, non-medicated, reusable
U BAR
MEDLINE INDUSTRIES, INC.
DYNJ902374B
In Commercial Distribution

  • 10889942361793 ()
DYNJ902374B

  • General surgical procedure kit, non-medicated, reusable
U BAR
MEDLINE INDUSTRIES, INC.
DYNJ902374F
In Commercial Distribution

  • 10193489571615 ()
DYNJ902374F

  • General surgical procedure kit, non-medicated, single-use
U BAR
MEDLINE INDUSTRIES, INC.
DYNJ902374A
In Commercial Distribution

  • 10889942195466 ()
DYNJ902374A

  • General surgical procedure kit, non-medicated, reusable
U Drape
O&M HALYARD, INC.
48067
In Commercial Distribution

  • 30680651480676 ()
  • 10680651480672 ()
48067

  • Patient surgical drape, single-use
U Drape
O&M HALYARD, INC.
48057
In Commercial Distribution

  • 30680651480577 ()
  • 10680651480573 ()
48057

  • Patient surgical drape, single-use
U Handle
Paragon 28, Inc.
P99-150-2007
In Commercial Distribution

  • 00889795130914 ()
P99-150-2007

  • Surgical instrument handle, torque-limiting
U BAR
MEDLINE INDUSTRIES, INC.
DYNJ908421B
In Commercial Distribution

  • 10195327410698 ()
DYNJ908421B

  • General surgical procedure kit, non-medicated, single-use
U BAR
MEDLINE INDUSTRIES, INC.
DYNJ902374L
In Commercial Distribution

  • 10198459128899 ()
DYNJ902374L

  • General surgical procedure kit, non-medicated, single-use
TRIAL (U)
KURARAY NORITAKE DENTAL INC.
#4232-KA
In Commercial Distribution

  • EKUR004232KA1 ()


  • Dental composite resin
PLT (U)
KURARAY NORITAKE DENTAL INC.
#3191-KA
In Commercial Distribution

  • EKUR003191KA0 ()
  • EKUR003191KA1 ()


  • Dental composite resin
Syringe (U)
KURARAY NORITAKE DENTAL INC.
#3181-KA
In Commercial Distribution

  • EKUR003181KA1 ()


  • Dental composite resin
U Drape
O&M HALYARD, INC.
48069
In Commercial Distribution

  • 90680651480692 ()
  • 30680651480690 ()
48069

  • Patient surgical drape, single-use, non-sterile
U BAR
MEDLINE INDUSTRIES, INC.
DYNJ902374K
In Commercial Distribution

  • 10195327505844 ()
DYNJ902374K

  • General surgical procedure kit, non-medicated, single-use
No Description
BIOARRAY SOLUTIONS LTD
800-10242
In Commercial Distribution

  • 10888234100928 ()
800-10242

  • Multiple blood group genotyping IVD, reagent
No Description
BIOARRAY SOLUTIONS LTD
800-00287
In Commercial Distribution

  • 10888234100836 ()
800-00287

  • Multiple blood group genotyping IVD, reagent
No Description
BIOARRAY SOLUTIONS LTD
800-00195
In Commercial Distribution

  • 10888234100683 ()
800-00195

  • Multiple blood group genotyping IVD, reagent
No Description
BIOARRAY SOLUTIONS LTD
800-00194
In Commercial Distribution

  • 10888234100669 ()
800-00194

  • Multiple blood group genotyping IVD, reagent
No Description
BIOARRAY SOLUTIONS LTD
800-00193
In Commercial Distribution

  • 10888234100645 ()
800-00193

  • Multiple blood group genotyping IVD, reagent
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