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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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Mediocarpal Plate, 5 Holes, - 00840118102957

Compatible with 1.5mm/2.0mm/2.4mm screws, implants for orthopedic bone fixation
FLOWER ORTHOPEDICS CORPORATION
FMP 211
In Commercial Distribution

  • 00840118102957 ()

  • Height: 1.5 Millimeter


  • Orthopaedic fixation plate, non-bioabsorbable

Recon Plate, 5 Holes, - 00840118101042

Compatible with 2.7mm/3.5mm screws, implants for orthopedic bone fixation
FLOWER ORTHOPEDICS CORPORATION
FRP 930
In Commercial Distribution

  • 00840118101042 ()

  • Height: 3.7 Millimeter


  • Orthopaedic fixation plate, non-bioabsorbable

NORMAL CDT CONTROL (5 ) - 03607360047958

5 VIALS
SEBIA
4795
In Commercial Distribution

  • 03607360047958 ()
4795

  • Carbohydrate deficient transferrin IVD, control

MOLECULAR MASS CONTROL (5) - 03607360047811

No Description
SEBIA
4781
In Commercial Distribution

  • 03607360047811 ()
4781

  • Protein electrophoresis IVD, control

Hb AFSA2 CONTROL (5) - 03607360047590

No Description
SEBIA
4759
In Commercial Distribution

  • 03607360047590 ()
4759

  • Haemoglobin detection IVD, control

RESPONDER 5, ENHANCED, GETWELL - 00840828108522

RESPONDER 5, ENHANCED, GETWELL
CURBELL MEDICAL PRODUCTS, INC.
4C412U-001370A
In Commercial Distribution

  • 00840828108522 ()
2071

  • Pillow speaker

RESPONDER 5, ENHANCED, GETWELL - 00840828108515

RESPONDER 5, ENHANCED, GETWELL
CURBELL MEDICAL PRODUCTS, INC.
4C412U-001022A
In Commercial Distribution

  • 00840828108515 ()
2070

  • Pillow speaker

RESPONDER 5, ENHANCED, GETWELL - 00840828108508

RESPONDER 5, ENHANCED, GETWELL
CURBELL MEDICAL PRODUCTS, INC.
4C412U-001020A
In Commercial Distribution

  • 00840828108508 ()
2069

  • Pillow speaker

RESPONDER 5, ENHANCED, GETWELL - 00840828108492

RESPONDER 5, ENHANCED, GETWELL
CURBELL MEDICAL PRODUCTS, INC.
4C412U-0010201
In Commercial Distribution

  • 00840828108492 ()
2068

  • Pillow speaker

RESPONDER 5, ENHANCED, GETWELL - 00840828108485

RESPONDER 5, ENHANCED, GETWELL
CURBELL MEDICAL PRODUCTS, INC.
4C412U-000020A
In Commercial Distribution

  • 00840828108485 ()
2067

  • Pillow speaker

THINFLAP SYSTEM 5/PK - 00841036138233

No Description
BIOMET MICROFIXATION, INC
91-6604-5PK
Not in Commercial Distribution

  • 00841036138233 ()
91-6604-5PK

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

THINFLAP SYSTEM 5/PK - 00841036190408

No Description
BIOMET MICROFIXATION, INC
91-6804-5PK
Not in Commercial Distribution

  • 00841036190408 ()
91-6804-5PK

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Iperia 5 HF-T QP - 04035479140137

No Description
BIOTRONIK SE & Co. KG
402658
Not in Commercial Distribution

  • 04035479140137 ()
402658

  • Cardiac resynchronization therapy implantable defibrillator

Itrevia 5 VR-T DX - 04035479129705

No Description
BIOTRONIK SE & Co. KG
393055
Not in Commercial Distribution

  • 04035479129705 ()
393055

  • Single-chamber implantable defibrillator

Iperia 5 VR-T DX - 04035479129644

No Description
BIOTRONIK SE & Co. KG
393049
Not in Commercial Distribution

  • 04035479129644 ()
393049

  • Single-chamber implantable defibrillator

Ilesto 5 VR-T DX - 04035479125523

No Description
BIOTRONIK SE & Co. KG
383596
Not in Commercial Distribution

  • 04035479125523 ()
383596

  • Single-chamber implantable defibrillator

Ilesto 5 VR-T DF4 - 04035479125400

No Description
BIOTRONIK SE & Co. KG
383584
Not in Commercial Distribution

  • 04035479125400 ()
383584

  • Single-chamber implantable defibrillator

Ilesto 5 DR-T DF4 - 04035479125240

No Description
BIOTRONIK SE & Co. KG
383568
Not in Commercial Distribution

  • 04035479125240 ()
383568

  • Dual-chamber implantable defibrillator

Uni-Tip -Package of 5 - 00014081124104

Chrome-plated air/water syringe
HAGER WORLDWIDE, INC.
BOA124P1000
Not in Commercial Distribution

  • 00014081124104 ()


  • Dental delivery system irrigation handpiece tip

5% Acetic Acid Solution - 00814963021121

No Description
ROCKWELL MEDICAL, INC.
R-100
In Commercial Distribution

  • 00814963021121 ()
  • 10814963021128 ()
R-100

  • Haemodialysis concentrate

TITANIT 5 95H25 Special - D800MEAL9625

Content: 1 piece Height: 25 mm High-quality medical titanium alloy (Ti-6Al-4V ELI according to ASTM F136 and ISO 5832-3) for the production of specific metal structures. Info: our Titan has a new name: Titanit. Properties and range of applications remain unchanged.
ZIRKONZAHN SRL
MEAL9625
In Commercial Distribution

  • D800MEAL9625 ()


  • Dental bridge, metal-ceramic

TITANIT 5 95H19 Special - D800MEAL9619

Content: 1 piece Height: 19 mm High-quality medical titanium alloy (Ti-6Al-4V ELI according to ASTM F136 and ISO 5832-3) for the production of specific metal structures. Info: our Titan has a new name: Titanit. Properties and range of applications remain unchanged.
ZIRKONZAHN SRL
MEAL9619
In Commercial Distribution

  • D800MEAL9619 ()


  • Dental bridge, metal-ceramic

TITANIT 5 95H17 Special - D800MEAL9617

Content: 1 piece Height: 17 mm High-quality medical titanium alloy (Ti-6Al-4V ELI according to ASTM F136 and ISO 5832-3) for the production of specific metal structures. Info: our Titan has a new name: Titanit. Properties and range of applications remain unchanged.
ZIRKONZAHN SRL
MEAL9617
In Commercial Distribution

  • D800MEAL9617 ()


  • Dental bridge, metal-ceramic

TITANIT 5 95H15 Special - D800MEAL9615

Content: 1 piece Height: 15 mm High-quality medical titanium alloy (Ti-6Al-4V ELI according to ASTM F136 and ISO 5832-3) for the production of specific metal structures. Info: our Titan has a new name: Titanit. Properties and range of applications remain unchanged.
ZIRKONZAHN SRL
MEAL9615
In Commercial Distribution

  • D800MEAL9615 ()


  • Dental bridge, metal-ceramic

TITANIT 5 95H13 Special - D800MEAL9613

Content: 1 piece Height: 13 mm High-quality medical titanium alloy (Ti-6Al-4V ELI according to ASTM F136 and ISO 5832-3) for the production of specific metal structures. Info: our Titan has a new name: Titanit. Properties and range of applications remain unchanged.
ZIRKONZAHN SRL
MEAL9613
In Commercial Distribution

  • D800MEAL9613 ()


  • Dental bridge, metal-ceramic

TITANIT 5 95H11 Special - D800MEAL9611

Content: 1 piece Height: 11 mm High-quality medical titanium alloy (Ti-6Al-4V ELI according to ASTM F136 and ISO 5832-3) for the production of specific metal structures. Info: our Titan has a new name: Titanit. Properties and range of applications remain unchanged.
ZIRKONZAHN SRL
MEAL9611
In Commercial Distribution

  • D800MEAL9611 ()


  • Dental bridge, metal-ceramic

BIOCRYL ICE 5# POLYMER - D7750470050

No Description
Great Lakes Dental Technologies, Ltd.
047-005
In Commercial Distribution

  • D7750470050 ()


  • Dental prosthesis restorative material, unfilled resin

BIOCRYL ICE 5# KIT - D7750470020

No Description
Great Lakes Dental Technologies, Ltd.
047-002
In Commercial Distribution

  • D7750470020 ()


  • Dental prosthesis restorative material, unfilled resin

CYSTATHIONINE PLUS LEVEL 5 - B800CYST5LC0

CYSTATHIONINE PLUS LEVEL 5
UTAK LABORATORIES, INC.
CYST+ 5 LC
In Commercial Distribution

  • B800CYST5LC5 ()
  • B800CYST5LC0 ()

  • Total Volume: 5 Milliliter
CYST+ 5 LC

  • Multiple-type clinical chemistry analyte profile IVD, control

BUSULFAN CALIBRATOR LEVEL 5 - B800BUSCAL5SJCR0

BUSULFAN CALIBRATOR LEVEL 5
UTAK LABORATORIES, INC.
BUS CAL 5 SJCR
In Commercial Distribution

  • B800BUSCAL5SJCR5 ()
  • B800BUSCAL5SJCR0 ()

  • Total Volume: 5 Milliliter
BUS CAL 5 SJCR

  • Multiple drugs of abuse IVD, control

DAU CALIBRATOR LEVEL 5 - B80004240000050

No Description
UTAK LABORATORIES, INC.
DAU CAL 5 V4 F SEMCE
In Commercial Distribution

  • B80004240000050 ()
  • B80004240000051 ()
  • B80004240000052 ()
  • B80004240000053 ()
  • B80004240000056 ()
  • B80004240000057 ()
  • B80004240000058 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

Validity Control Level 5 - B800170140

Validity Control Level 5
UTAK LABORATORIES, INC.
17014
In Commercial Distribution

  • B800170140 ()
  • B800170145 ()

  • Total Volume: 25 Milliliter
17014

  • Multiple urine analyte IVD, control

THC PLUS LEVEL 5 - B800THC5UFWCT0

THC PLUS LEVEL 5
UTAK LABORATORIES, INC.
THC+ 5 U F WCT
In Commercial Distribution

  • B800THC5UFWCT5 ()
  • B800THC5UFWCT0 ()

  • Total Volume: 10 Milliliter
THC+ 5 U F WCT

  • Multiple-type clinical chemistry analyte profile IVD, control

MORPHINE 5 NG/M - B800POSM24512ML0

MORPHINE 5 NG/M
UTAK LABORATORIES, INC.
pos-m245-1-2ml
In Commercial Distribution

  • B800POSM24512ML0 ()

  • Total Volume: 2 Milliliter
pos-m245-1-2ml

  • Multiple-therapy therapeutic drug monitoring IVD, control

PETH LEVEL 5 V2 - B800PETH5V2WBFHFHS0

PETH LEVEL 5 V2
UTAK LABORATORIES, INC.
PETH 5 V2 WB F HFHS
In Commercial Distribution

  • B800PETH5V2WBFHFHS5 ()
  • B800PETH5V2WBFHFHS0 ()

  • Total Volume: 2 Milliliter
PETH 5 V2 WB F HFHS

  • Multiple drugs of abuse IVD, control

PENTOBARBITAL 5 UG/ML - B800PENTO5JHH0

PENTOBARBITAL 5 UG/ML
UTAK LABORATORIES, INC.
PENTO 5 JHH
In Commercial Distribution

  • B800PENTO5JHH0 ()
  • B800PENTO5JHH5 ()

  • Total Volume: 5 Milliliter
PENTO 5 JHH

  • Multiple-type clinical chemistry analyte profile IVD, control

OPIATES CALIBRATOR LEVEL 5 - B800OPIUCAL5UNC0

OPIATES CALIBRATOR LEVEL 5
UTAK LABORATORIES, INC.
OPI U CAL 5 UNC
In Commercial Distribution

  • B800OPIUCAL5UNC5 ()
  • B800OPIUCAL5UNC0 ()

  • Total Volume: 2 Milliliter
OPI U CAL 5 UNC

  • Multiple therapeutic drugs/drugs of abuse IVD, control

MYCOPHENOLIC ACID LEVEL 5 - B800MPA5SMAYO0

MYCOPHENOLIC ACID LEVEL 5
UTAK LABORATORIES, INC.
MPA 5 S MAYO
In Commercial Distribution

  • B800MPA5SMAYO5 ()
  • B800MPA5SMAYO0 ()

  • Total Volume: .25 Milliliter
MPA 5 S MAYO

  • Multiple-type clinical chemistry analyte profile IVD, control

METHOTREXATE 5 UMOL/L - B800METHO5SUPHS0

METHOTREXATE 5 UMOL/L
UTAK LABORATORIES, INC.
METHO 5 S UPHS
In Commercial Distribution

  • B800METHO5SUPHS0 ()

  • Total Volume: 5 Milliliter
METHO 5 S UPHS

  • Multiple-type clinical chemistry analyte profile IVD, control

SAVUCONAZOLE PLUS CALIBRATOR 5 - B800ISACAL5SFUCSF0

SAVUCONAZOLE PLUS CALIBRATOR 5
UTAK LABORATORIES, INC.
ISA+ CAL 5 S F UCSF
In Commercial Distribution

  • B800ISACAL5SFUCSF5 ()
  • B800ISACAL5SFUCSF0 ()

  • Total Volume: 0.5 Milliliter
ISA+ CAL 5 S F UCSF

  • Multiple-type clinical chemistry analyte profile IVD, control
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