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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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BeadCheck HEA Ref-pB, Bulk and Fill - 10888234102328

No Description
BIOARRAY SOLUTIONS LTD
800-00229
In Commercial Distribution

  • 10888234102328 ()
800-00229

  • Multiple blood group genotyping IVD, control

BeadCheck HEA Ref-pA, Bulk and Fill - 10888234102298

No Description
BIOARRAY SOLUTIONS LTD
800-00228
In Commercial Distribution

  • 10888234102298 ()
800-00228

  • Multiple blood group genotyping IVD, control

Immucor Precise TypeTM Human Erythrocyte Antigen Molecular BeadChip Test Slides - 10888234100065

No Description
BIOARRAY SOLUTIONS LTD
800-20202-08
In Commercial Distribution

  • 10888234100065 ()
800-20202-08

  • Multiple blood group genotyping IVD, nucleic acid technique (NAT)

ID CORE XT - 08437013457019

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)

LANCER™ Pedicle Screw System - 00840996109635

UNIV,ROD,STRAIGHT,CO,5.5X90
Choice Spine, LP
MC40-S090
In Commercial Distribution

  • 00840996109635 ()

  • Length: 90 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

LANCER™ Pedicle Screw System - 00840996109482

UNIV,ROD,PREBENT,CO,5.5X90
Choice Spine, LP
MC40-P090
In Commercial Distribution

  • 00840996109482 ()

  • Length: 90 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

THUNDERBOLT™ Minimally Invasive Pedicle Screw Systems - 00840996108553

TBOLT,ROD,STRAIGHT,CO,5.5X90
Choice Spine, LP
MC20-S090
In Commercial Distribution

  • 00840996108553 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 90 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

THUNDERBOLT™ Minimally Invasive Pedicle Screw Systems - 00840996108348

TBOLT,ROD,PREBENT,CO,5.5X90
Choice Spine, LP
MC20-P090
In Commercial Distribution

  • 00840996108348 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 90 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

BLACKBIRD™ Spinal System - 00840996107587

UNIV,ROD,STRAIGHT,CO,3.5X90
Choice Spine, LP
LC40-S090
In Commercial Distribution

  • 00840996107587 ()

  • Length: 90 Millimeter
  • Outer Diameter: 3.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

BLACKBIRD™ Spinal System - 00840996107457

UNIV,ROD,PREBENT,CO,3.5X90
Choice Spine, LP
LC40-P090
In Commercial Distribution

  • 00840996107457 ()

  • Outer Diameter: 3.5 Millimeter
  • Length: 90 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

Filled Vial,HotStarTaq DNA Polymerase - 10888234100928

No Description
BIOARRAY SOLUTIONS LTD
800-10242
In Commercial Distribution

  • 10888234100928 ()
800-10242

  • Multiple blood group genotyping IVD, reagent

Filled Vial,Negative Control 1mL - 10888234100836

No Description
BIOARRAY SOLUTIONS LTD
800-00287
In Commercial Distribution

  • 10888234100836 ()
800-00287

  • Multiple blood group genotyping IVD, reagent

Filled Vial, Lambda Exonuclease - 10888234100683

No Description
BIOARRAY SOLUTIONS LTD
800-00195
In Commercial Distribution

  • 10888234100683 ()
800-00195

  • Multiple blood group genotyping IVD, reagent

Filled Vial, HEA 1.2 PCR Mix - 10888234100669

No Description
BIOARRAY SOLUTIONS LTD
800-00194
In Commercial Distribution

  • 10888234100669 ()
800-00194

  • Multiple blood group genotyping IVD, reagent

Filled Vial, eMAPTM Elongation Mix - 10888234100645

No Description
BIOARRAY SOLUTIONS LTD
800-00193
In Commercial Distribution

  • 10888234100645 ()
800-00193

  • Multiple blood group genotyping IVD, reagent

Filled Vial, Clean-up, 330uL - 10888234100621

No Description
BIOARRAY SOLUTIONS LTD
800-00191
In Commercial Distribution

  • 10888234100621 ()
800-00191

  • Multiple blood group genotyping IVD, reagent

EVONOS GMBH & Co. Kg - 00821925011991

JORDAN CAPSULE KNIFE 1 MM BLADE LENGTH STAINLESS STEEL EBONY FINISH
Gyrus ACMI, LLC
130393
In Commercial Distribution

  • 00821925011991 ()


  • Middle ear pick

EVONOS GMBH & Co. Kg - 00821925011977

JORDAN PICK 90 DEGREE TIP ANGLE, LEFT .70 MM TIP LENGTH STAINLESS STEEL
Gyrus ACMI, LLC
130391
In Commercial Distribution

  • 00821925011977 ()


  • Middle ear pick

EVONOS GMBH & Co. Kg - 00821925011953

JORDAN PICK 90 DEGREE TIP ANGLE, RIGHT .70 MM TIP LENGTH STAINLESS STEEL
Gyrus ACMI, LLC
130389
In Commercial Distribution

  • 00821925011953 ()


  • Middle ear pick

Lamitrode® - 05414734402248

88 Lead Kit, 60cm Length
ADVANCED NEUROMODULATION SYSTEMS, INC.
3288
In Commercial Distribution

  • 05414734402248 ()

  • Length: 60 Centimeter
3288

  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection

LANCER™ Pedicle Screw System - 00840996109000

UNIV,ROD,STRAIGHT HEX,CO,5.5X90
Choice Spine, LP
MC40-H090
In Commercial Distribution

  • 00840996109000 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 90 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

Hu-Friedy MFG Co., LLC. - 10889950023294

#7K SE Hoe Scaler
HU-FRIEDY MFG. CO., LLC
S7K
In Commercial Distribution

  • 10889950023294 ()


  • Periodontal hoe

Hu-Friedy MFG Co., LLC. - 10889950023102

44/45 Remington DE Hoe Scaler
HU-FRIEDY MFG. CO., LLC
S44/456
In Commercial Distribution

  • 10889950023102 ()


  • Periodontal hoe

Hu-Friedy MFG Co., LLC. - 10889950023096

#44/45 Remington DE Hoe Scaler
HU-FRIEDY MFG. CO., LLC
S44/45
In Commercial Distribution

  • 10889950023096 ()


  • Periodontal hoe

Hu-Friedy MFG Co., LLC. - 10889950043377

32/33 HOE DE
HU-FRIEDY MFG. CO., LLC
CP1252
Not in Commercial Distribution

  • 10889950043377 ()


  • Periodontal hoe

Hu-Friedy MFG Co., LLC. - 10889950033194

#WV1/2 DE Hoe Scaler
HU-FRIEDY MFG. CO., LLC
SWV1/2
In Commercial Distribution

  • 10889950033194 ()


  • Periodontal hoe

Hu-Friedy MFG Co., LLC. - 10889950030667

#8/9 Orban DE Hoe Scaler
HU-FRIEDY MFG. CO., LLC
SO8/96
In Commercial Distribution

  • 10889950030667 ()


  • Periodontal hoe

Hu-Friedy MFG Co., LLC. - 10889950030650

#8/9 Orban DE Hoe Scaler
HU-FRIEDY MFG. CO., LLC
SO8/9
In Commercial Distribution

  • 10889950030650 ()


  • Periodontal hoe

Hu-Friedy MFG Co., LLC. - 10889950030643

6/7 ORBAN DE HOE SCALER SATIN STEEL HDL
HU-FRIEDY MFG. CO., LLC
SO6/76
In Commercial Distribution

  • 10889950030643 ()


  • Periodontal hoe

Hu-Friedy MFG Co., LLC. - 10889950030636

#6/7 Orban DE Hoe Scaler
HU-FRIEDY MFG. CO., LLC
SO6/7
In Commercial Distribution

  • 10889950030636 ()


  • Periodontal hoe

Hu-Friedy MFG Co., LLC - 10889950097172

#9 McCall SE Hoe Scaler
HU-FRIEDY MFG. CO., LLC
SM9
In Commercial Distribution

  • 10889950097172 ()


  • Periodontal hoe

Hu-Friedy MFG Co., LLC - 10889950097158

#7/9 McCall DE Hoe Scaler
HU-FRIEDY MFG. CO., LLC
SM7/9
In Commercial Distribution

  • 10889950097158 ()


  • Periodontal hoe

Hu-Friedy MFG Co., LLC. - 10889950093693

Goldman Fox #5 HOE Scaler DE #6 HDL
HU-FRIEDY MFG. CO., LLC
SC6612
In Commercial Distribution

  • 10889950093693 ()


  • Periodontal hoe

Hu-Friedy MFG Co., LLC. - 10889950092979

#7K SE Hoe Scaler, SATIN STEEL
HU-FRIEDY MFG. CO., LLC
SC52986
In Commercial Distribution

  • 10889950092979 ()


  • Periodontal hoe

Hu-Friedy MFG Co., LLC. - 10889950089863

Concavity Hoe Scaler DE CH5/6 #7 Hdl Red
HU-FRIEDY MFG. CO., LLC
S156/5776
In Commercial Distribution

  • 10889950089863 ()


  • Periodontal hoe

Hu-Friedy MFG Co., LLC. - 10889950097264

#8/9 MacFarlane DE Hoe, #7, Yellow
HU-FRIEDY MFG. CO., LLC
SMF8/975
In Commercial Distribution

  • 10889950097264 ()


  • Periodontal hoe

Hu-Friedy MFG Co., LLC - 10889950097240

#6/7 MacFarlane DE Hoe, #7, Orange
HU-FRIEDY MFG. CO., LLC
SMF6/773
In Commercial Distribution

  • 10889950097240 ()


  • Periodontal hoe

Hu-Friedy MFG Co., LLC - 10889950097189

#9 McCALL SE HOE SCALER SATIN STL HANDLE
HU-FRIEDY MFG. CO., LLC
SM96
In Commercial Distribution

  • 10889950097189 ()


  • Periodontal hoe

Arjo Wiggins Medical, Inc. - 00815588024719

88 54X54,100_CASE
STERIMED INC.
1010885454D
In Commercial Distribution

  • 00815588024719 ()
  • 00815588024702 ()
1010885454D

  • Sterilization packaging, single-use

Arjo Wiggins Medical, Inc. - 00815588024672

88 54X54,100_CASE
STERIMED INC.
1010885454D
In Commercial Distribution

  • 00815588024672 ()
  • 00815588024665 ()
1010885454D

  • Sterilization packaging, single-use

Arjo Wiggins Medical, Inc. - 00815588024597

88 48X48,100_CASE
STERIMED INC.
1010884848D
In Commercial Distribution

  • 00815588024597 ()
  • 00815588024580 ()
1010884848D

  • Sterilization packaging, single-use

Arjo Wiggins Medical, Inc. - 00815588024573

88 48X48,100_CASE
STERIMED INC.
1010884848D
In Commercial Distribution

  • 00815588024573 ()
  • 00815588024566 ()
1010884848D

  • Sterilization packaging, single-use

Arjo Wiggins Medical, Inc. - 00815588024535

88 45X45,100_CASE
STERIMED INC.
1010884545D
In Commercial Distribution

  • 00815588024535 ()
  • 00815588024900 ()
1010884545D

  • Sterilization packaging, single-use

Arjo Wiggins Medical, Inc. - 00815588024528

88 45X45,100_CASE
STERIMED INC.
1010884545D
In Commercial Distribution

  • 00815588024528 ()
  • 00815588024894 ()
1010884545D

  • Sterilization packaging, single-use

Arjo Wiggins Medical, Inc. - 00815588024450

88 40X40,100_CASE
STERIMED INC.
1010884040D
In Commercial Distribution

  • 00815588024450 ()
  • 00815588024863 ()
1010884040D

  • Sterilization packaging, single-use

Arjo Wiggins Medical, Inc. - 00815588024443

88 40X40,100_CASE
STERIMED INC.
1010884040D
In Commercial Distribution

  • 00815588024443 ()
  • 00815588024856 ()
1010884040D

  • Sterilization packaging, single-use

Arjo Wiggins Medical, Inc. - 00815588024399

88 36X36,150_CASE
STERIMED INC.
1010883636D
In Commercial Distribution

  • 00815588024399 ()
  • 00815588024382 ()
1010883636D

  • Sterilization packaging, single-use

Arjo Wiggins Medical, Inc. - 00815588024375

88 36X36,150_CASE
STERIMED INC.
1010883636D
In Commercial Distribution

  • 00815588024375 ()
  • 00815588024368 ()
1010883636D

  • Sterilization packaging, single-use

Arjo Wiggins Medical, Inc. - 00815588024344

88 32X32,250_CASE
STERIMED INC.
1010883232G
In Commercial Distribution

  • 00815588024344 ()
  • 00815588024337 ()
1010883232G

  • Sterilization packaging, single-use

Arjo Wiggins Medical, Inc. - 00815588024306

88 30X30,250_CASE
STERIMED INC.
1010883030D
In Commercial Distribution

  • 00815588024306 ()
1010883030D

  • Sterilization packaging, single-use
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