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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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Tinto ZFAND3 (BSB-169) - B502BSB3797150

Tinto ZFAND3 is a mouse monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
BSB-3797-15
In Commercial Distribution

  • B502BSB3797150 ()

  • Total Volume: 15 Milliliter
BSB-3797-15

  • AN1-type zinc finger protein 3 (ZFAND3) IVD, antibody

ID CORE CONTROL - 08437013457040

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

TIDI - 00618125183685

RECTANGLE, .88" x 3" x 5", 1 Each
TIDI PRODUCTS, LLC
33274
In Commercial Distribution

  • 00618125183685 ()


  • Multifunction body cushion

JUNIORTHO PLATING SYSTEM - 18053800899755

JPS SS LOCKING SCREW L16MM DOUBLE START THREAD D3.0MM
ORTHOFIX SRL
1
In Commercial Distribution

  • 18053800899755 ()

  • Width: 88 Millimeter
5413016

  • Orthopaedic bone screw, non-bioabsorbable, sterile

EVONOS GMBH & Co - 00821925012424

GUILFORD ADHESION PICK 45 DEGREE TIP ANGLE 1 MM TIP ANGLE STAINLESS STEEL
Gyrus ACMI, LLC
130260
In Commercial Distribution

  • 00821925012424 ()


  • Middle ear pick

FREE GLIDING SCFE SCREW SYSTEM - 07540194002549

Female Component 88/90mm Ø7.3mm
Orthopediatrics Canada ULC
SCF-F73-88S/90L
In Commercial Distribution

  • 07540194002549 ()

  • Length: 88 Millimeter
  • Outer Diameter: 7.3 Millimeter
  • Length: 90 Millimeter
SCF-F73-88S/90L

  • Orthopaedic bone screw (non-sliding)

FREE GLIDING SCFE SCREW SYSTEM - 07540194002365

Female Component 88/90mm Ø6.5mm
Orthopediatrics Canada ULC
SCF-F65-88S/90L
In Commercial Distribution

  • 07540194002365 ()

  • Outer Diameter: 6.5 Millimeter
  • Length: 88 Millimeter
  • Length: 90 Millimeter
SCF-F65-88S/90L

  • Orthopaedic bone screw (non-sliding)

Hemo-QC - 00858352006009

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

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)

Precise TypeTM HEA BeadCheck Kit - 10888234102632

No Description
BIOARRAY SOLUTIONS LTD
800-20236
In Commercial Distribution

  • 10888234102632 ()
800-20236

  • Multiple blood group genotyping IVD, control

Immucor Precise TypeTM Human Erythrocyte Antigen Molecular BeadChip Test Plate - 10888234102618

No Description
BIOARRAY SOLUTIONS LTD
800-20202-96
In Commercial Distribution

  • 10888234102618 ()
800-20202-96

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

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

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, 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,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, 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. - 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. - 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. - 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. - 10889950023294

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

  • 10889950023294 ()


  • Periodontal hoe
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