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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BUSULFAN CALIBRATOR LEVEL 2 V2
UTAK LABORATORIES, INC.
BUS CAL 2 V2 DP F MDACC
In Commercial Distribution

  • B800BUSCAL2V2DPFMDACC5 ()
  • B800BUSCAL2V2DPFMDACC0 ()

  • Total Volume: 1.5 Milliliter
BUS CAL 2 V2 DP F MDACC

  • Multiple-type clinical chemistry analyte profile IVD, control
BUSULFAN CALIBRATOR LEVEL 1 V2
UTAK LABORATORIES, INC.
BUS CAL 1 V2 DP F MDACC
In Commercial Distribution

  • B800BUSCAL1V2DPFMDACC5 ()
  • B800BUSCAL1V2DPFMDACC0 ()

  • Total Volume: 1.5 Milliliter
BUS CAL 1 V2 DP F MDACC

  • Multiple-type clinical chemistry analyte profile IVD, control
BUPRENORPHINE PLUS LEVEL 2 V2
UTAK LABORATORIES, INC.
BUP+ 2 V2 U KP
In Commercial Distribution

  • B800BUP2V2UKP5 ()
  • B800BUP2V2UKP0 ()

  • Total Volume: 1 Milliliter
BUP+ 2 V2 U KP

  • Multiple drugs of abuse IVD, control
BUPRENORPHINE PLUS LEVEL 2 V2
UTAK LABORATORIES, INC.
BUP+ 2 V2 U F MAYO
In Commercial Distribution

  • B800BUP2V2UFMAYO5 ()
  • B800BUP2V2UFMAYO0 ()

  • Total Volume: 1 Milliliter
BUP+ 2 V2 U F MAYO

  • Multiple-type clinical chemistry analyte profile IVD, control
BUPRENORPHINE PLUS LEVEL 1 V2
UTAK LABORATORIES, INC.
BUP+ 1 V2 U F MAYO
In Commercial Distribution

  • B800BUP1V2UFMAYO5 ()
  • B800BUP1V2UFMAYO0 ()

  • Total Volume: 1 Milliliter
BUP+ 1 V2 U F MAYO

  • Multiple-type clinical chemistry analyte profile IVD, control
COTININE PLUS LEVEL 1 V2
UTAK LABORATORIES, INC.
COT+ 1 V2 S LC
In Commercial Distribution

  • B800COT1V2SLC5 ()
  • B800COT1V2SLC0 ()

  • Total Volume: 5 Milliliter
COT+ 1 V2 S LC

  • Multiple-type clinical chemistry analyte profile IVD, control
CLOZAPINE 50 NG/ML V2
UTAK LABORATORIES, INC.
CLOZ 50 V2 UCI
In Commercial Distribution

  • B800CLOZ50V2UCI5 ()
  • B800CLOZ50V2UCI0 ()

  • Total Volume: 5 Milliliter
CLOZ 50 V2 UCI

  • Multiple-type clinical chemistry analyte profile IVD, control
BUSULFAN CALIBRATOR LEVEL 6 V2
UTAK LABORATORIES, INC.
BUS CAL 6 V2 DP F MDACC
In Commercial Distribution

  • B800BUSCAL6V2DPFMDACC5 ()
  • B800BUSCAL6V2DPFMDACC0 ()

  • Total Volume: 1.5 Milliliter
BUS CAL 6 V2 DP F MDACC

  • Multiple-type clinical chemistry analyte profile IVD, control
BUSULFAN CALIBRATOR LEVEL 4 V2
UTAK LABORATORIES, INC.
BUS CAL 4 V2 DP F MDACC
In Commercial Distribution

  • B800BUSCAL4V2DPFMDACC5 ()
  • B800BUSCAL4V2DPFMDACC0 ()

  • Total Volume: 1.5 Milliliter
BUS CAL 4 V2 DP F MDACC

  • Multiple-type clinical chemistry analyte profile IVD, control
BUSULFAN CALIBRATOR LEVEL 3 V2
UTAK LABORATORIES, INC.
BUS CAL 3 V2 DP F MDACC
In Commercial Distribution

  • B800BUSCAL3V2DPFMDACC5 ()
  • B800BUSCAL3V2DPFMDACC0 ()

  • Total Volume: 1.5 Milliliter
BUS CAL 3 V2 DP F MDACC

  • Multiple-type clinical chemistry analyte profile IVD, control
BUPRENORPHINE PLUS LEVEL 3 V2
UTAK LABORATORIES, INC.
BUP+ 3 V2 U F MAYO
In Commercial Distribution

  • B800BUP3V2UFMAYO5 ()
  • B800BUP3V2UFMAYO0 ()

  • Total Volume: 1 Milliliter
BUP+ 3 V2 U F MAYO

  • Multiple-type clinical chemistry analyte profile IVD, control
ARACHIDIC ACID LEVEL 3 V2
UTAK LABORATORIES, INC.
ARA+ 3 V2 S ID
In Commercial Distribution

  • B800ARA3V2SID5 ()
  • B800ARA3V2SID0 ()

  • Total Volume: 3 Milliliter
ARA+ 3 V2 S ID

  • Multiple-type clinical chemistry analyte profile IVD, control
ARACHIDIC ACID LEVEL 2 V2
UTAK LABORATORIES, INC.
ARA+ 2 V2 S ID
In Commercial Distribution

  • B800ARA2V2SID5 ()
  • B800ARA2V2SID0 ()

  • Total Volume: 3 Milliliter
ARA+ 2 V2 S ID

  • Multiple-type clinical chemistry analyte profile IVD, control
ARACHIDIC ACID LEVEL 1 V2
UTAK LABORATORIES, INC.
ARA+ 1 V2 S ID
In Commercial Distribution

  • B800ARA1V2SID5 ()
  • B800ARA1V2SID0 ()

  • Total Volume: 3 Milliliter
ARA+ 1 V2 S ID

  • Multiple-type clinical chemistry analyte profile IVD, control
ANABASINE PLUS LEVEL 2 V2
UTAK LABORATORIES, INC.
ANAB+ 2 V2 U LC
In Commercial Distribution

  • B800ANAB2V2ULC5 ()
  • B800ANAB2V2ULC0 ()

  • Total Volume: 5 Milliliter
ANAB+ 2 V2 U LC

  • Multiple-type clinical chemistry analyte profile IVD, control
ANABASINE PLUS LEVEL 1 V2
UTAK LABORATORIES, INC.
ANAB+ 1 V2 U LC
In Commercial Distribution

  • B800ANAB1V2ULC5 ()
  • B800ANAB1V2ULC0 ()

  • Total Volume: 5 Milliliter
ANAB+ 1 V2 U LC

  • Multiple-type clinical chemistry analyte profile IVD, control
AMITRIPTYLINE PLUS LEVEL 2 V2
UTAK LABORATORIES, INC.
AMIT+ 2 V2 S SH
In Commercial Distribution

  • B800AMIT2V2SSH5 ()
  • B800AMIT2V2SSH0 ()

  • Total Volume: 3 Milliliter
AMIT+ 2 V2 S SH

  • Multiple-type clinical chemistry analyte profile IVD, control
AMITRIPTYLINE PLUS LEVEL 1 V2
UTAK LABORATORIES, INC.
AMIT+ 1 V2 S SH
In Commercial Distribution

  • B800AMIT1V2SSH5 ()
  • B800AMIT1V2SSH0 ()

  • Total Volume: 3 Milliliter
AMIT+ 1 V2 S SH

  • Multiple-type clinical chemistry analyte profile IVD, control
NORMAL RANGE TRACE ELEMENTS V2
UTAK LABORATORIES, INC.
66816 NR V2 LC
In Commercial Distribution

  • B80066816NRV2LC5 ()
  • B80066816NRV2LC0 ()

  • Total Volume: 5 Milliliter
66816 NR V2 LC

  • Multiple-type clinical chemistry analyte profile IVD, control
HIGH RANGE TRACE ELEMENTS V2
UTAK LABORATORIES, INC.
66815 HR V2 LC
In Commercial Distribution

  • B80066815HRV2LC0 ()

  • Total Volume: 5 Milliliter
66815 HR V2 LC

  • Multiple-type clinical chemistry analyte profile IVD, control
Bitewing Bite Blocks, Red, V2
PLASDENT CORPORATION
XR-0941
In Commercial Distribution

  • D832XR09410 ()
  • D832XR09411 ()
XR-0941

  • Dental x-ray system beam alignment device
ORTHOPILOT ACL V2 INSTRUMENT SET
Aesculap AG
FS860M
In Commercial Distribution

  • 04038653417780 ()
FS860M

  • Orthopaedic prosthesis implantation positioning instrument, reusable
TRITON,T50 DRIVER,V2 PWE
Choice Spine, LP
Q070-0024
In Commercial Distribution

  • 00840996192866 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated
NAVIGATION,TRITON DRVR V2,NVL
Choice Spine, LP
NV70-Q007
In Commercial Distribution

  • 00840996192750 ()


  • Orthopaedic implant driver
BLACKHAWK TI,CAM DRIVER,V2
Choice Spine, LP
T070-0018
In Commercial Distribution

  • 00840996187541 ()


  • Orthopaedic implant driver
ACAPELLA,SHORT DBL IMPACT V2
Choice Spine, LP
05-099-02-1200
In Commercial Distribution

  • 00840996152785 ()


  • Polymeric spinal interbody fusion cage
ACAPELLA,SHORT DBL IMPACT V2
Choice Spine, LP
05-099-02-1100
In Commercial Distribution

  • 00840996152778 ()


  • Polymeric spinal interbody fusion cage
GIBRALT,CONNECTOR,SET SCREW,V2
Choice Spine, LP
05-000-24-2000
In Commercial Distribution

  • 00840996170109 ()


  • Bone-screw internal spinal fixation system, non-sterile
Expro Elite Snare V2 35mm
TELEFLEX INCORPORATED
IPN913622
In Commercial Distribution

  • 30841156101590 ()
  • 10841156101596 ()

  • Width: 35 Millimeter
8404

  • Intravascular extraction catheter-snare
Expro Elite Snare V2 25mm
TELEFLEX INCORPORATED
IPN913620
In Commercial Distribution

  • 30841156101576 ()
  • 10841156101572 ()

  • Width: 25 Millimeter
8403

  • Intravascular extraction catheter-snare
Expro Elite Snare V2 15mm
TELEFLEX INCORPORATED
IPN913618
In Commercial Distribution

  • 30841156101552 ()
  • 10841156101558 ()

  • Width: 15 Millimeter
8402

  • Intravascular extraction catheter-snare
Expro Elite Snare V2 10mm
TELEFLEX INCORPORATED
IPN913616
In Commercial Distribution

  • 30841156101538 ()
  • 10841156101534 ()

  • Width: 10 Millimeter
8401

  • Intravascular extraction catheter-snare
Expro Elite Snare V2 5mm
TELEFLEX INCORPORATED
IPN913614
In Commercial Distribution

  • 30841156101514 ()
  • 10841156101510 ()

  • Width: 5 Millimeter
8400

  • Intravascular extraction catheter-snare
AMNIOTIC FLUID COLLECT KIT V2
MEDLINE INDUSTRIES, INC.
DYNJ59769
In Commercial Distribution

  • 10888277782747 ()
DYNJ59769

  • General surgical procedure kit, non-medicated, single-use
Natus Elite v2 Software Update
NATUS NEUROLOGY INCORPORATED
688-630000
In Commercial Distribution

  • 00382830062268 ()


  • Electromyograph
Natus Elite v2 Software Upgrade
NATUS NEUROLOGY INCORPORATED
688-630100
In Commercial Distribution

  • 00382830062244 ()


  • Electromyograph
Natus Elite v2 Software - Synergy
NATUS NEUROLOGY INCORPORATED
828-080100
In Commercial Distribution

  • 00382830062206 ()


  • Electromyograph
Natus Elite v2 Reader Software
NATUS NEUROLOGY INCORPORATED
828-080000
In Commercial Distribution

  • 00382830062237 ()


  • Electromyograph
Natus Elite v2 Software - Viking
NATUS NEUROLOGY INCORPORATED
828-080200
In Commercial Distribution

  • 00382830062213 ()


  • Electromyograph
ELITE 2MHZ WATERPROOF PROBE V2
NATUS NEUROLOGY INCORPORATED
X1L008
In Commercial Distribution

  • 00382830028196 ()


  • Foetal Doppler system
Apnea Guard Device High (V2)
ADVANCED BRAIN MONITORING, INC.
25-1003
In Commercial Distribution

  • 00850015266027 ()


  • Mandible-repositioning sleep-disordered breathing orthosis
Apnea Guard Device Medium (V2)
ADVANCED BRAIN MONITORING, INC.
25-1002
In Commercial Distribution

  • 00850015266010 ()


  • Mandible-repositioning sleep-disordered breathing orthosis
RETRACTOR HOLDER 9734119 HEADHOLDER V2
MEDTRONIC NAVIGATION, INC.
9734119
In Commercial Distribution

  • 00613994575463 ()


  • Extremity MRI system, permanent magnet
TROCAR VERSAPORT PLUS V2 LONG
STERILMED, INC.
AUT179097P
Not in Commercial Distribution

  • 10888551013208 ()
AUT179097P

  • Laparoscopic trocar blade, reprocessed
Apnea Guard Device Low (V2)
ADVANCED BRAIN MONITORING, INC.
25-1001
In Commercial Distribution

  • 00850015266003 ()


  • Mandible-repositioning sleep-disordered breathing orthosis
AIRFIT N30I SML STPK V2
RESMED PTY LTD
63839
In Commercial Distribution

  • 00619498638390 ()
63839

  • CPAP/BPAP nasal mask, reusable
AIRFIT N30I STD STPK V2
RESMED PTY LTD
63838
In Commercial Distribution

  • 00619498638383 ()
63838

  • CPAP/BPAP nasal mask, reusable
AIRTOUCH N30I SML STPK V2
RESMED PTY LTD
62309
In Commercial Distribution

  • 00619498623099 ()
62309

  • CPAP/BPAP nasal mask, reusable
AIRTOUCH N30I STD STPK V2
RESMED PTY LTD
62308
In Commercial Distribution

  • 00619498623082 ()
62308

  • CPAP/BPAP nasal mask, reusable
MAF v2 Probe Red (ASR)
CYTOCELL LIMITED
LPH567-A
In Commercial Distribution



  • Assay development analyte-specific reagent IVD
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