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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ISAVUCONAZOLE PLUS CALIBRATOR 6 V2
UTAK LABORATORIES, INC.
ISA+ CAL 6 V2 S F UCSF
In Commercial Distribution

  • B800ISACAL6V2SFUCSF5 ()
  • B800ISACAL6V2SFUCSF0 ()

  • Total Volume: 1 Milliliter
ISA+ CAL 6 V2 S F UCSF

  • Multiple-type clinical chemistry analyte profile IVD, control
ISAVUCONAZOLE PLUS CALIBRATOR 5 V2
UTAK LABORATORIES, INC.
ISA+ CAL 5 V2 S F UCSF
In Commercial Distribution

  • B800ISACAL5V2SFUCSF5 ()
  • B800ISACAL5V2SFUCSF0 ()

  • Total Volume: 1 Milliliter
ISA+ CAL 5 V2 S F UCSF

  • Multiple-type clinical chemistry analyte profile IVD, control
ISAVUCONAZOLE PLUS CALIBRATOR 4 V2
UTAK LABORATORIES, INC.
ISA+ CAL 4 V2 S F UCSF
In Commercial Distribution

  • B800ISACAL4V2SFUCSF5 ()
  • B800ISACAL4V2SFUCSF0 ()

  • Total Volume: 1 Milliliter
ISA+ CAL 4 V2 S F UCSF

  • Multiple-type clinical chemistry analyte profile IVD, control
ISAVUCONAZOLE PLUS CALIBRATOR 3 V2
UTAK LABORATORIES, INC.
ISA+ CAL 3 V2 S F UCSF
In Commercial Distribution

  • B800ISACAL3V2SFUCSF5 ()
  • B800ISACAL3V2SFUCSF0 ()

  • Total Volume: 1 Milliliter
ISA+ CAL 3 V2 S F UCSF

  • Multiple-type clinical chemistry analyte profile IVD, control
ISAVUCONAZOLE PLUS CALIBRATOR 2 V2
UTAK LABORATORIES, INC.
ISA+ CAL 2 V2 S F UCSF
In Commercial Distribution

  • B800ISACAL2V2SFUCSF5 ()
  • B800ISACAL2V2SFUCSF0 ()

  • Total Volume: 1 Milliliter
ISA+ CAL 2 V2 S F UCSF

  • Multiple-type clinical chemistry analyte profile IVD, control
SERUM DRUGS LEVEL 2 V2
UTAK LABORATORIES, INC.
DRUGS 2 V2 S SH
In Commercial Distribution

  • B800DRUGS2V2SSH5 ()
  • B800DRUGS2V2SSH0 ()

  • Total Volume: 3 Milliliter
DRUGS 2 V2 S SH

  • Multiple-type clinical chemistry analyte profile IVD, control
SERUM DRUGS LEVEL 1 V2
UTAK LABORATORIES, INC.
DRUGS 1 V2 S SH
In Commercial Distribution

  • B800DRUGS1V2SSH5 ()
  • B800DRUGS1V2SSH0 ()

  • Total Volume: 3 Milliliter
DRUGS 1 V2 S SH

  • Multiple-type clinical chemistry analyte profile IVD, control
Orthex P&C Software v2
ORTHOPEDIATRICS CORP.
ORTHEXSW
In Commercial Distribution

  • 00840194428002 ()
ORTHEXSW

  • External orthopaedic fixation frame calculation software
GIBRALT,CONNECTOR,SET SCREW,V2
Choice Spine, LP
05-000-24-2000
In Commercial Distribution

  • 00840996170109 ()


  • Bone-screw internal spinal fixation system, non-sterile
BLACKHAWK TI,CAM DRIVER,V2
Choice Spine, LP
T070-0018
In Commercial Distribution

  • 00840996187541 ()


  • Orthopaedic implant driver
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
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
ORTHOPILOT ACL V2 INSTRUMENT SET
Aesculap AG
FS860M
In Commercial Distribution

  • 04038653417780 ()
FS860M

  • Orthopaedic prosthesis implantation positioning instrument, reusable
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
Bitewing Bite Blocks, Red, V2
PLASDENT CORPORATION
XR-0941
In Commercial Distribution

  • D832XR09410 ()
  • D832XR09411 ()
XR-0941

  • Dental x-ray system beam alignment device
Advanced Pin Clamp V2 – Non-Sterile
Wishbone Medical, Inc.
720-000005T
Not in Commercial Distribution

  • B562720000005T0 ()


  • External orthopaedic fixation system, single-use
MASK ADPT V2 22ID POLYS
HANS RUDOLPH, INC.
7450
In Commercial Distribution

  • 00817136027326 ()
612857

  • Pulmonary function valve
Standard Pin Clamp V2 – Non-Sterile
Wishbone Medical, Inc.
720-000004T
Not in Commercial Distribution

  • B562720000004T0 ()


  • External orthopaedic fixation system, single-use
ANCHOR INSERTER INNER TUBE V2
ZIMMER BIOMET INC
230H1002
In Commercial Distribution

  • 00887868227332 ()


  • Spinal dynamic-stabilization system
ANCHOR INSERTER OUTER TUBE V2
ZIMMER BIOMET INC
230H1001
In Commercial Distribution

  • 00887868227325 ()


  • Spinal dynamic-stabilization system
REVELATION V2 OSTEOTOMY GUIDE, SIZE8
Encore Medical, L.P.
803-04-151
In Commercial Distribution

  • 00888912091817 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
REVELATION V2 OSTEOTOMY GUIDE, SIZE15
Encore Medical, L.P.
803-04-119
In Commercial Distribution

  • 00888912091725 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
REVELATION V2 OSTEOTOMY GUIDE, SIZE12
Encore Medical, L.P.
803-04-117
In Commercial Distribution

  • 00888912091701 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
REVELATION V2 OSTEOTOMY GUIDE, SIZE10.5
Encore Medical, L.P.
803-04-116
In Commercial Distribution

  • 00888912091695 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
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