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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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
Post-Mortem Bag Kit (Body Bag) Adult 36"x90", Contents include: Body Bag, (3) Toe-Tags, Shroud Sheet, (4) Precaution Labels, White Vinyl Disposable gloves
Dynarex Corporation
4772
In Commercial Distribution

  • 00616784477237 ()
  • 00616784477213 ()


  • Cadaver bag
Windsor Slit Knife/ Keratome 20 gauge angled sideport. Single bevel up full handle. Sterile. Single use
CORE SURGICAL LIMITED
WK20GBU
In Commercial Distribution

  • 15060510711751 ()
  • 05060510711754 ()
WK20GBU

  • Ophthalmic knife, single-use
AirLife DuoTherm® Neonate Dual Limb Circuit Kit
AIRLIFE
37723CE
In Commercial Distribution

  • 30889483631359 ()
  • 10889483631355 ()
37723CE

  • Oxygen administration kit
VST Mini Blue, sterile, 0.075” x 18” / 0.2 cm x 46 cm
Batrik Medical Manufacturing Inc
VL2202
In Commercial Distribution

  • 00690521023314 ()
  • 00690521023208 ()
VL2202

  • Surgical vessel loop
No Description
Terumo Cardiovascular Systems Corporation
76940
In Commercial Distribution

  • 50699753509455 ()
  • 00699753509450 ()


  • Cardiopulmonary bypass system blood tubing set
Mermaid Medical® Guidewire .035” x 150 cm, 3.5 cm (Straight Tip)
TECHDEVICE CORPORATION
G60235150
In Commercial Distribution

  • 00850758007048 ()
  • 20850758007042 ()

  • 3.5 Centimeter Tip (Straight)
  • Outer Diameter: 0.035 Inch
  • Length: 150 Centimeter
G60235150

  • Peripheral vascular guidewire, manual
BLUE NITRILE EXAM POWDER FREE GLOVE - X-SMALL (Case) 1/10/100
CLEAN SAFETY INC.
CS4300
In Commercial Distribution

  • 00859116003944 ()
  • 10859116003941 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Hybrid needles (Stimulation + ultrasound) 21G x 95 mm
Temena GmbH
EH095-21
In Commercial Distribution

  • 03700339704279 ()
  • 03700339714278 ()

  • Needle Gauge: 21 Gauge
  • Length: 95 Millimeter
  • Angle: 20 degree
EH095-21

  • Peripheral nerve-block sharp needle
The Liofilchem® MTS™ (MIC Test Strip) is a quantitative method intended for the in vitro determination ofantimicrobial susceptibility of bacteria MTS™ consists ofspecialized papyr impregnated with a pre-defined concentration gradient ofan antimicrobial agent, which is used to determine the minimum inhibitozy concentration (MIC) in µglmL ofantimicrobial agents against bacteria as tested on agar media using ovemight incubation and manual reading procedures. The MTS™ Plazomicin at concentrations of0.016-256 µglmL should be interpreted at 16-20 hours of incubation. MTS™ PLZ can be used to dete1mine the MIC ofplazomicin against the microorganisms listed below: Plazomicin Activity According to the FDA Label Clinical and in vitro Enterobacter cloacae Escherichia coli Klebsiella pneumoniae Proteus mirabilis in vitro only Citrobacterfreundii Citrobacter koseri Klebsiella (Enterobacter) aerogenes Klebsiella oxytoca Morganella morganii Proteus vulgaris Providencia stuartii Serratia marcescens
LIOFILCHEM SRL
Plazomicin 0.016-256 µg/mL
In Commercial Distribution

  • 08055182872367 ()
  • 08055182872343 ()
  • 18055182872364 ()
$92070-10

  • Plazomicin minimum inhibitory concentration (MIC) IVD
Coccyx Cushion, 18x16x3 Memory Foam
COMPASS HEALTH BRANDS CORP.
COC-18
In Commercial Distribution

  • 80092237604270 ()
  • 00815067043637 ()


  • Soft-rubber chair cushion
  • Wheelchair seat cushion
PF BLACK NITRILE EXAM GLOVE, M
MCKESSON MEDICAL-SURGICAL INC.
27-74
Not in Commercial Distribution

  • 00815555025091 ()
  • 00815555025084 ()
  • 00815555025152 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Custom Cut Silicone Sheeting For Internal Nasal Splints & Packing, 2.2 X 3.0 X 0.040", Singles
INVOTEC INTERNATIONAL, INC.
20-10680S
In Commercial Distribution

  • 10818501021045 ()
  • 00818501021048 ()
20-10680S

  • Intranasal splint, non-biodegradable
Invotec Tympanostomy Tube, Shepard Grommet, ID 1.02mm, FLPL
INVOTEC INTERNATIONAL, INC.
1
In Commercial Distribution

  • 10818501020307 ()
  • 00818501020300 ()
23-40120

  • Tympanostomy tube
Easy@Home Urinary Tract Infection Test Strips (10 Pack)
EASY HEALTHCARE CORPORATION
EZU-101
In Commercial Distribution

  • 10810038631445 ()
  • 00810038631448 ()
  • 30810038631449 ()
EZU-101-10

  • Multiple urinary tract infection-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)
  • Multiple urinary tract pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
NASOPHARYNGEAL AIRWAY 28 FR
KENTRON HEALTHCARE, INC.
804428
In Commercial Distribution

  • 10810003751116 ()
  • 00810003751119 ()


  • Nasopharyngeal airway, single-use
NASOPHARYNGEAL AIRWAY ROBERTAZZI STYLE 26 FR
KENTRON HEALTHCARE, INC.
804426
In Commercial Distribution

  • 10810003751109 ()
  • 00810003751102 ()


  • Nasopharyngeal airway, single-use
Sperm Maintenance Medium
FUJIFILM IRVINE SCIENTIFIC, INC.
99176-12X5ML
Not in Commercial Distribution

  • 00857515006061 ()
  • 10857515006068 ()

  • Total Volume: 5 Milliliter
99176

  • IVF medium
Sperm Maintenance Medium
FUJIFILM IRVINE SCIENTIFIC, INC.
99176-100ml
Not in Commercial Distribution

  • 00893727002965 ()

  • Total Volume: 100 Milliliter
99176

  • IVF medium
VEGA NV STRAIGHT ABUTMENT [AT3-AP4.5]
SOADCO, S.L.
18 10 10
In Commercial Distribution

  • 08435451605641 ()
18 10 10

  • Dental implant suprastructure kit
ESSENTIAL® CONE Ø4.8 X 10MM IMPLANT
SOADCO, S.L.
10 48 10
In Commercial Distribution

  • 08435451603043 ()
10 48 10

  • Screw endosteal dental implant, one-piece
ESSENTIAL® CONE Ø4.5 X 10MM IMPLANT
SOADCO, S.L.
10 45 10
In Commercial Distribution

  • 08435451603005 ()
10 45 10

  • Screw endosteal dental implant, one-piece
ESSENTIAL® CONE Ø4.0 X 10MM IMPLANT
SOADCO, S.L.
10 40 10
In Commercial Distribution

  • 08435451602961 ()
10 40 10

  • Screw endosteal dental implant, one-piece
ESSENTIAL® CONE Ø3.5 X 10MM IMPLANT
SOADCO, S.L.
10 35 10
In Commercial Distribution

  • 08435451602923 ()
10 35 10

  • Screw endosteal dental implant, one-piece
EC Ti-BASE SCAN ABUTMENT
SOADCO, S.L.
10 10 20-SA
In Commercial Distribution

  • 08435451602749 ()
10 10 20-SA

  • Dental implant suprastructure kit
EC Ti-BASE SCAN ABUTMENT
SOADCO, S.L.
10 10 20-SA
In Commercial Distribution

  • 08435451602732 ()
10 10 20-SA

  • Dental milling system, CAD/CAM, laboratory
EC ESSENTIAL Ti-BASE ABUTMENT [AP5]
SOADCO, S.L.
10 10 20
In Commercial Distribution

  • 08435451602701 ()
10 10 20

  • Dental implant suprastructure kit
MANUAL EXTRACTOR WRENCH FOR EC 12° ABUTMENTS
SOADCO, S.L.
10 07 10
In Commercial Distribution

  • 08435451602671 ()
10 07 10

  • Surgical screwdriver, reusable
EC 17° ANGULAR OCTACONE® MULTI-CONE ABUTMENT [AT3-AP2.4]
SOADCO, S.L.
10 10 44
In Commercial Distribution

  • 08435451602091 ()
10 10 44

  • Dental implant suprastructure kit
EC 17° ANGULAR OCTACONE® MULTI-CONE ABUTMENT [M-AT2-AP2.4]
SOADCO, S.L.
10 10 43
In Commercial Distribution

  • 08435451602084 ()
10 10 43

  • Dental implant suprastructure kit
EC 25° ABUTMENT [M-AT4-AP5.5]
SOADCO, S.L.
10 10 42
In Commercial Distribution

  • 08435451602077 ()
10 10 42

  • Dental implant suprastructure kit
EC 25° ABUTMENT [M-AT2.5-AP4]
SOADCO, S.L.
10 10 41
In Commercial Distribution

  • 08435451602060 ()
10 10 41

  • Dental implant suprastructure kit
EC 25° ABUTMENT [M-AT1-AP2.5]
SOADCO, S.L.
10 10 40
In Commercial Distribution

  • 08435451602053 ()
10 10 40

  • Dental implant suprastructure kit
EC 30° ANGULAR OCTACONE® MULTI-CONE ABUTMENT [AT4-AP2.4]
SOADCO, S.L.
10 10 37
In Commercial Distribution

  • 08435451602039 ()
10 10 37

  • Dental implant suprastructure kit
EC 30° ANGULAR OCTACONE® MULTI-CONE ABUTMENT [M-AT3-AP2.4]
SOADCO, S.L.
10 10 36
In Commercial Distribution

  • 08435451602022 ()
10 10 36

  • Dental implant suprastructure kit
EC 17° ANGULAR OCTACONE®ABUTMENT [AP6]
SOADCO, S.L.
10 10 34
In Commercial Distribution

  • 08435451602008 ()
10 10 34

  • Dental implant suprastructure kit
EC 22° ANGULAR OCTACONE®ABUTMENT [AP6]
SOADCO, S.L.
10 10 31
In Commercial Distribution

  • 08435451601988 ()
10 10 31

  • Dental implant suprastructure kit
EC OCTACONE® TEMPORARY AESTHETIC ABUTMENT [M-AT4.2-AP7.5]
SOADCO, S.L.
10 10 25
In Commercial Distribution

  • 08435451601964 ()
10 10 25

  • Dental implant suprastructure kit
EC OCTACONE® TEMPORARY AESTHETIC ABUTMENT [U-AT4.2-AP7.5]
SOADCO, S.L.
10 10 24
In Commercial Distribution

  • 08435451601940 ()
10 10 24

  • Dental implant suprastructure kit
EC TEMPORARY OCTACONE® ABUTMENT [M-AT0.4-AP9]
SOADCO, S.L.
10 10 23
In Commercial Distribution

  • 08435451601926 ()
10 10 23

  • Dental implant suprastructure kit
EC SCAN OCTACONE® ABUTMENT
SOADCO, S.L.
10 10 21
In Commercial Distribution

  • 08435451601902 ()
10 10 21

  • Dental implant suprastructure kit
EC TEMPORARY OCTACONE® ABUTMENT [U-AT0.4-AP9]
SOADCO, S.L.
10 10 19
In Commercial Distribution

  • 08435451601889 ()
10 10 19

  • Dental implant suprastructure kit
EC MACHINABLE OCTACONE® ABUTMENT [AP8]
SOADCO, S.L.
10 10 18
In Commercial Distribution

  • 08435451601872 ()
10 10 18

  • Dental implant suprastructure kit
EC CoCr OCTACONE® ABUTMENT [AP12]
SOADCO, S.L.
10 10 16
In Commercial Distribution

  • 08435451601858 ()
10 10 16

  • Dental implant suprastructure kit
EC 25° ABUTMENT [AP1]
SOADCO, S.L.
10 10 15
In Commercial Distribution

  • 08435451601841 ()
10 10 15

  • Dental implant suprastructure kit
EC 12° OCTACONE® ABUTMENT [AT0-AP2]
SOADCO, S.L.
10 10 14
In Commercial Distribution

  • 08435451601827 ()
10 10 14

  • Dental implant suprastructure kit
EC GOLD OCTACONE® ABUTMENT [AP12]
SOADCO, S.L.
10 10 13
In Commercial Distribution

  • 08435451601803 ()
10 10 13

  • Dental implant suprastructure kit
EC 22° ANGULAR OCTACONE® ABUTMENT [AP7]
SOADCO, S.L.
10 10 12
In Commercial Distribution

  • 08435451601780 ()
10 10 12

  • Dental implant suprastructure kit
EC 17° ANGULAR OCTACONE® ABUTMENT [AP7]
SOADCO, S.L.
10 10 11
In Commercial Distribution

  • 08435451601766 ()
10 10 11

  • Dental implant suprastructure kit
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