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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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NeuroBalloon™ NEUROBALLOON™ CATHETER
Integra LifeSciences Switzerland Sàrl
7CBD10
In Commercial Distribution

  • M2727CBD101 ()
  • 10381780035343 ()

  • Balloon waist diameter upon inflation: 3.5 mm minimum at 0.6 ml (0.6cc) of air, 6 mm maximum at 1 ml (1cc) of air; Cath. 60cm mini. Length; for insertion into a F4 minimum (1.35mm) diameter channel
7CBD10

  • Neural-tissue balloon catheter
INSTRUMENT 9790910 FIXED ANGLE AWL
MEDTRONIC SOFAMOR DANEK, INC.
9790910
In Commercial Distribution

  • 00721902989605 ()


  • Bone awl, reusable
AWL 9730820 TACTILE
MEDTRONIC NAVIGATION, INC.
9730820
In Commercial Distribution

  • 00721902984433 ()


  • Bone awl, reusable
SQUARE AWL W/ INLINE HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
7480107
Not in Commercial Distribution

  • 00721902859496 ()


  • Bone awl, reusable
INSTRUMENT 7480104 ROUND AWL INLINE HNDL
MEDTRONIC SOFAMOR DANEK, INC.
7480104
In Commercial Distribution

  • 00721902855979 ()


  • Bone awl, reusable
INSTRUMENT 9339004 STAPLE GUIDE THORACIC
MEDTRONIC SOFAMOR DANEK, INC.
9339004
In Commercial Distribution

  • 00721902816390 ()


  • Bone awl, reusable
OBWEGESER ZYGOMATIC ARCH AWL 9 1/2" 24CM
TELEFLEX INCORPORATED
IPN022530
In Commercial Distribution

  • 54026704811347 ()
  • 14026704811349 ()
P34854

  • Bone awl, reusable
aprevo® Angled Awl
Carlsmed, Inc.
1530
In Commercial Distribution

  • 00810056993023 ()


  • Bone awl, single-use
aprevo® Straight Awl
Carlsmed, Inc.
1510
In Commercial Distribution

  • 00810056993009 ()


  • Bone awl, single-use
aprevo® Cervical Angled Awl
Carlsmed, Inc.
1380
In Commercial Distribution

  • 00810056991999 ()


  • Bone awl, single-use
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