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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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No Description
Merit Medical
00884450258187
In Commercial Distribution

  • 00884450258187 ()

  • Tip Gauge-21G
  • Curve Angle-50°
  • Gauge-18G
  • Length (cm)-82 cm


  • Cardiac transseptal needle, single-use
BONACCOLTO UTILITY FORCEPS 1.7MM
KATENA PRODUCTS, INC.
AE-4441
In Commercial Distribution

  • 00841668135594 ()

  • Width: 1.5 Millimeter
AE-4441

  • Dressing/utility forceps, tweezers-like, reusable
The BProSOftCASP® 24-Hour Ambulatory Blood Pressure and CASP Monitoring System is a noninvasive ambulatory blood pressure monitoring (ABPM) system based on arterial tonometry at the radial artery and oscillometry at the upper arm. It is used for measuring systolic pressure (SYS), diastolic pressure (DIA), pulse rate (PR) and the Central Aortic Systolic Pressure (CASP) of adults.
HEALTHSTATS INTERNATIONAL PTE LTD
T6300 Series
Not in Commercial Distribution

  • 08885014410081 ()


  • Blood pressure ambulatory recorder
The Lumbar Catheter Accessory Kit (LCAK) is designed for cerebrospinal fluid drainage, and consists of: a 80 cm radiopaque lumbar catheter (F5) with graphite based length marks at 2 cm intervals (first mark at 10 cm from the closed tip); a guidewire in dispenser; a Luer-lock connector; a butterfly suture clamp; a 14-ga, thin-wall Tuohy needle with obturator.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
910121
Not in Commercial Distribution

  • 10381780034124 ()
  • M2729101211 ()

  • Lumbar Cath. 80cm Length x 1.6mm O.D. x 0.8mm I.D. (F5), 14G Tuohy Needle
910121

  • Lumbar cerebrospinal fluid drainage catheterization kit
The VASCADE VCS is intended to seal femoral vessel puncture sites at the completion of catheter-based procedures. The system is designed to deliver a resorbable Collagen Patch, extra-vascularly, at the vessel puncture site to achieve hemostasis. For use in 6F & 7F introducer sheaths; overall length of the sheath (including the hub) needs to be less than 15cm.
CARDIVA MEDICAL, INC.
700-580I
In Commercial Distribution

  • M729700580I1 ()
  • M729700580I0 ()
  • M729700580I3 ()

  • Catheter Gauge: 7 French
  • Catheter Gauge: 6 French


  • Femoral artery closure plug/patch, collagen
The VASCADE VCS is intended to seal femoral vessel puncture sites at the completion of catheter-based procedures. The system is designed to deliver a resorbable Collagen Patch, extra-vascularly, at the vessel puncture site to achieve hemostasis. For use in 5F introducer sheaths; overall length of the sheath (including the hub) needs to be less than 15cm.
CARDIVA MEDICAL, INC.
700-500DX
In Commercial Distribution

  • M729700500DX1 ()
  • M729700500DX0 ()
  • M729700500DX3 ()

  • Catheter Gauge: 5 French


  • Femoral artery closure plug/patch, collagen
The Unite Medical® suspension sleeve is worn in conjunction with a knee orthosis to help suspend brace and prevent knee orthosis from migrating.
Unite Medical, LLC
Suspension Sleeve (Universal)
In Commercial Distribution

  • 00850012035329 ()
SS2397

  • Orthosis suspension unit
No Description
Dassiet Oy
X5250
In Commercial Distribution

  • 06430053269200 ()


  • Orthosis suspension unit
BD LUER-LOK ACCESS DEVICE
BECTON, DICKINSON AND COMPANY
36490200
In Commercial Distribution

  • 60382903649022 ()
  • 00382903649020 ()
36490200

  • Luer-ended blood collection tube spike
OLSEN HEGAR NEEDLE HOLDER 5.5
MEDLINE INDUSTRIES, INC.
DYND04123
In Commercial Distribution

  • 40888277557322 ()
  • 10888277557321 ()
DYND04123

  • Surgical soft-tissue manipulation forceps, tweezers-like, single-use
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