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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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HP PRO Solution - Hand hold B
Orfit Industries NV
25000/17/B
In Commercial Distribution

  • 05420028775042 ()


  • Radiological whole-body positioner
mat. for inlays, onlays, c&b
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
574563
Not in Commercial Distribution

  • DIVO5745631 ()
  • DIVO5745630 ()
574563

  • Dental appliance fabrication material, ceramic
mat. for inlays, onlays, c&b
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
574561
Not in Commercial Distribution

  • DIVO5745611 ()
  • DIVO5745610 ()
574561

  • Dental appliance fabrication material, ceramic
mat. for inlays, onlays, c&b
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
574560
Not in Commercial Distribution

  • DIVO5745601 ()
  • DIVO5745600 ()
574560

  • Dental appliance fabrication material, ceramic
mat. for inlays, onlays, c&b
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
574559
Not in Commercial Distribution

  • DIVO5745591 ()
  • DIVO5745590 ()
574559

  • Dental appliance fabrication material, ceramic
mat. for inlays, onlays, c&b
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
574553
Not in Commercial Distribution

  • DIVO5745531 ()
  • DIVO5745530 ()
574553

  • Dental appliance fabrication material, ceramic
mat. for inlays, onlays, c&b
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
574522
Not in Commercial Distribution

  • DIVO5745221 ()
  • DIVO5745220 ()
574522

  • Dental appliance fabrication material, ceramic
mat. for inlays, onlays, c&b
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
574521
Not in Commercial Distribution

  • DIVO5745211 ()
  • DIVO5745210 ()
574521

  • Dental appliance fabrication material, ceramic
mat. for inlays, onlays, c&b
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
574519
Not in Commercial Distribution

  • DIVO5745191 ()
  • DIVO5745190 ()
574519

  • Dental appliance fabrication material, ceramic
mat. for inlays, onlays, c&b
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
574517
Not in Commercial Distribution

  • DIVO5745171 ()
  • DIVO5745170 ()
574517

  • Dental appliance fabrication material, ceramic
mat. for inlays, onlays, c&b
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
574516
Not in Commercial Distribution

  • DIVO5745161 ()
  • DIVO5745160 ()
574516

  • Dental appliance fabrication material, ceramic
mat. for inlays, onlays, c&b
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
574515
Not in Commercial Distribution

  • DIVO5745151 ()
  • DIVO5745150 ()
574515

  • Dental appliance fabrication material, ceramic
mat. for inlays, onlays, c&b
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
574514
Not in Commercial Distribution

  • DIVO5745141 ()
  • DIVO5745140 ()
574514

  • Dental appliance fabrication material, ceramic
mat. for inlays, onlays, c&b
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
574513
Not in Commercial Distribution

  • DIVO5745131 ()
  • DIVO5745130 ()
574513

  • Dental appliance fabrication material, ceramic
mat. for inlays, onlays, c&b
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
574512
Not in Commercial Distribution

  • DIVO5745121 ()
  • DIVO5745120 ()
574512

  • Dental appliance fabrication material, ceramic
mat. for inlays, onlays, c&b
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
574511
Not in Commercial Distribution

  • DIVO5745111 ()
  • DIVO5745110 ()
574511

  • Dental appliance fabrication material, ceramic
GEMINI STRAP SYSTEM,B,LOOP LOK
MORRISON MEDICAL, LTD
1383B-L
In Commercial Distribution

  • 00647921138322 ()
1383B-L

  • Limb/torso/head restraint, reusable
E8089 Crea B electrode for ABL8XX
Radiometer Medical ApS
945-663
In Commercial Distribution

  • 05700699456632 ()
945-663

  • Creatinine IVD, reagent
PK CUST C CABG A & B
ROI CPS, LLC
CV00080Y
Not in Commercial Distribution

  • 20194717113109 ()
  • 10194717113102 ()


  • Cardiothoracic surgical procedure kit, non-medicated, single-use
PEDI HEART W/TOWELS A&B
ROI CPS, LLC
CV00932G
Not in Commercial Distribution

  • 20194717112621 ()
  • 10194717112624 ()


  • Cardiothoracic surgical procedure kit, non-medicated, single-use
PEDI HEART W/TOWELS A&B
ROI CPS, LLC
CV00932F
Not in Commercial Distribution

  • 20194717110948 ()
  • 10194717110941 ()


  • Cardiothoracic surgical procedure kit, non-medicated, single-use
PEDI HEART W/TOWELS A&B
ROI CPS, LLC
CV00932E
Not in Commercial Distribution

  • 20194717109317 ()
  • 10194717109310 ()


  • Cardiothoracic surgical procedure kit, non-medicated, single-use
CV PACK A B OK HEART
MEDLINE INDUSTRIES, INC.
DYNJ65562C
In Commercial Distribution

  • 10193489965346 ()
DYNJ65562C

  • General surgical procedure kit, non-medicated, single-use
PK, OPEN HEART-CABG A/B/C
MEDLINE INDUSTRIES, INC.
DYNJ43544B
In Commercial Distribution

  • 10193489791105 ()
DYNJ43544B

  • General surgical procedure kit, non-medicated, single-use
Bile Acids Reagent B (25 mL)
TRINITY BIOTECH PUBLIC LIMITED COMPANY
450-2-25
In Commercial Distribution

  • 05391516741903 ()

  • Total Volume: 25 Milliliter
450-2-25

  • Total bile acid IVD, reagent
Bile Acids Reagent B (5 mL)
TRINITY BIOTECH PUBLIC LIMITED COMPANY
450-2
In Commercial Distribution

  • 05391516741880 ()

  • Total Volume: 5 Milliliter
450-2

  • Total bile acid IVD, reagent
OPEN HEART PACK A&B SM
MEDLINE INDUSTRIES, INC.
DYNJ51911A
In Commercial Distribution

  • 10889942321056 ()
DYNJ51911A

  • General surgical procedure kit, non-medicated, reusable
KIT C SEC PART B HILLCREST
MEDLINE INDUSTRIES, INC.
DYNJ907624
In Commercial Distribution

  • 10193489837476 ()
DYNJ907624

  • General surgical procedure kit, non-medicated, single-use
VALVE INTRA OP SURGICNT PACK B
MEDLINE INDUSTRIES, INC.
DYNJ61302C
In Commercial Distribution

  • 40193489903929 ()
  • 10193489903928 ()
DYNJ61302C

  • General surgical procedure kit, non-medicated, single-use
TRMC- TOTAL HIP PACK A&B
MEDLINE INDUSTRIES, INC.
DYNJ10131B
In Commercial Distribution

  • 10889942426102 ()
DYNJ10131B

  • General surgical procedure kit, non-medicated, single-use
TRMC- TOTAL KNEE PACK A&B
MEDLINE INDUSTRIES, INC.
DYNJ10132B
In Commercial Distribution

  • 10889942425853 ()
DYNJ10132B

  • General surgical procedure kit, non-medicated, single-use
BONE RECOVERY PK A&B ACCESSORY
MEDLINE INDUSTRIES, INC.
DYNJ37313Q
In Commercial Distribution

  • 10193489934359 ()
DYNJ37313Q

  • General surgical procedure kit, non-medicated, single-use
BONE RECOVERY PK A&B ACCESSORY
MEDLINE INDUSTRIES, INC.
DYNJ37313P
In Commercial Distribution

  • 10193489899528 ()
DYNJ37313P

  • General surgical procedure kit, non-medicated, single-use
KIT, GVI OPEN HEART A B
Cardinal Health 200, LLC
PCVNCG554
In Commercial Distribution

  • 50888439509203 ()
  • 10888439509205 ()
PCVNCG554

  • Cardiothoracic surgical procedure kit, medicated, single-use
OPEN HEART A AND B PACKS
Cardinal Health 200, LLC
SCV21OPAR3
In Commercial Distribution

  • 50888439498163 ()
  • 10888439498165 ()
SCV21OPAR3

  • Cardiothoracic surgical procedure kit, non-medicated, single-use
KIT, TRAUMA KNEE A AND B
Cardinal Health 200, LLC
PO11OTSSI
In Commercial Distribution

  • 50888439404447 ()
  • 10888439404449 ()
PO11OTSSI

  • Orthopaedic surgical procedure kit, medicated
KIT, TRAUMA HIP A AND B
Cardinal Health 200, LLC
PO11OTASSI
In Commercial Distribution

  • 50888439404430 ()
  • 10888439404432 ()
PO11OTASSI

  • Orthopaedic surgical procedure kit, medicated
RACK 9411902 19 22 25MM B
MEDTRONIC SOFAMOR DANEK, INC.
9411902
In Commercial Distribution

  • 00613994730138 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
KIT,OPEN HEART A B, MAIMONIDES
Cardinal Health 200, LLC
PCOCOH95O
In Commercial Distribution

  • 50888439537091 ()
  • 10888439537093 ()
PCOCOH95O

  • Cardiothoracic surgical procedure kit, medicated, single-use
KIT, IUS LIVER TRANS PART B
Cardinal Health 200, LLC
PGCGLBUHC
In Commercial Distribution

  • 50888439525340 ()
  • 10888439525342 ()
PGCGLBUHC

  • General surgical procedure kit, medicated
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