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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11" Ralk Universal Hand Drill
Surgical Direct, Inc.
SD91409800
In Commercial Distribution

  • B382SD914098000 ()
SD91409800

  • Bone tap, reusable
11" 14fr Lefort Urethral Sound
Surgical Direct, Inc.
SD91673099
In Commercial Distribution

  • B382SD916730990 ()
SD91673099

  • Fixed-diameter cervical dilator, reusable
11" 12fr Lefort Urethral Sound
Surgical Direct, Inc.
SD91673097
In Commercial Distribution

  • B382SD916730970 ()
SD91673097

  • Fixed-diameter cervical dilator, reusable
11" 10fr Lefort Urethral Sound
Surgical Direct, Inc.
SD91673095
In Commercial Distribution

  • B382SD916730950 ()
SD91673095

  • Fixed-diameter cervical dilator, reusable
11" 8fr Lefort Urethral Sound
Surgical Direct, Inc.
SD91673093
In Commercial Distribution

  • B382SD916730930 ()
SD91673093

  • Fixed-diameter cervical dilator, reusable
11" 30fr Lefort Urethral Sound
Surgical Direct, Inc.
SD916730113
In Commercial Distribution

  • B382SD9167301130 ()
SD916730113

  • Fixed-diameter cervical dilator, reusable
11" 28fr Lefort Urethral Sound
Surgical Direct, Inc.
SD916730111
In Commercial Distribution

  • B382SD9167301110 ()
SD916730111

  • Fixed-diameter cervical dilator, reusable
11" 26fr Lefort Urethral Sound
Surgical Direct, Inc.
SD916730109
In Commercial Distribution

  • B382SD9167301090 ()
SD916730109

  • Fixed-diameter cervical dilator, reusable
11" 24fr Lefort Urethral Sound
Surgical Direct, Inc.
SD916730107
In Commercial Distribution

  • B382SD9167301070 ()
SD916730107

  • Fixed-diameter cervical dilator, reusable
11" 22fr Lefort Urethral Sound
Surgical Direct, Inc.
SD916730105
In Commercial Distribution

  • B382SD9167301050 ()
SD916730105

  • Fixed-diameter cervical dilator, reusable
11" 20fr Lefort Urethral Sound
Surgical Direct, Inc.
SD916730103
In Commercial Distribution

  • B382SD9167301030 ()
SD916730103

  • Fixed-diameter cervical dilator, reusable
11" 18fr Lefort Urethral Sound
Surgical Direct, Inc.
SD916730101
In Commercial Distribution

  • B382SD9167301010 ()
SD916730101

  • Fixed-diameter cervical dilator, reusable
11" 16fr Lefort Urethral Sound
Surgical Direct, Inc.
SD916730100
In Commercial Distribution

  • B382SD9167301000 ()
SD916730100

  • Fixed-diameter cervical dilator, reusable
11" Mathieu Foreign Body Forceps
Surgical Direct, Inc.
SD91559821
In Commercial Distribution

  • B382SD915598210 ()
SD91559821

  • Dressing/utility forceps, scissors-like, reusable
11 mm Cannulated Headed Reamer
PARCUS MEDICAL LLC
10088
In Commercial Distribution

  • 00816342020602 ()


  • Cannulated surgical drill bit, reusable
CTA CUT GUIDE, SIZE 11
ARTHREX, INC.
AR-9200-21CA
In Commercial Distribution

  • 00888867136977 ()
AR-9200-21CA

  • Surgical drill guide, reusable
Axial Version - MasterLoc Broach # 11
Medacta International SA
01.39.10.0311
In Commercial Distribution

  • 07630345788771 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
STEM EXTENSION TRIAL-BOWED 11/200
DEPUY ORTHOPAEDICS, INC.
2987-15-311
In Commercial Distribution

  • 10603295157977 ()
298715311

  • Knee femur prosthesis trial, reusable
STEM EXTENSION TRIAL-BOWED 11/150
DEPUY ORTHOPAEDICS, INC.
2987-15-211
In Commercial Distribution

  • 10603295157878 ()
298715211

  • Knee femur prosthesis trial, reusable
Offset Lamina Spreader, 11" OL
BOSS INSTRUMENTS, LTD., INC.
73-1029
In Commercial Distribution

  • 00888515178168 ()
73-1029

  • Self-retaining surgical retractor, reusable
11 inch Switching Stick, 3.5mm
Surgical Direct, Inc.
SD48-10150
In Commercial Distribution

  • B382SD48101500 ()
SD48-10150

  • Laparoscopic access cannula, reusable
ELEOS™ INSTRUMENTATION TRAY, 11
ONKOS SURGICAL, INC.
002-03-00011
In Commercial Distribution

  • B27800203000110 ()
002-03-00011

  • Instrument tray, reusable
11 IN REAMER/IM ROD
ONKOS SURGICAL, INC.
K0001101E
In Commercial Distribution

  • B278K0001101E0 ()
K0001101E

  • General internal orthopaedic fixation system implantation kit
SMS Solid Stem STD #11
Medacta International SA
01.36.051
In Commercial Distribution

  • 07630030888700 ()


  • Press-fit hip femur prosthesis, one-piece
SMS Solid Stem LAT #11
Medacta International SA
01.36.071
In Commercial Distribution

  • 07630030888830 ()


  • Press-fit hip femur prosthesis, one-piece
Screw-retained Bridge, 11 units, Ti
Institut Straumann AG
Bridges (implant borne)
In Commercial Distribution

  • 07630031702173 ()
010.1085

  • Dental implant suprastructure, permanent, preformed
ACTIS REAMER SIZE 10/11
DEPUY (IRELAND)
2011-01-260
In Commercial Distribution

  • 10603295495710 ()
201101260

  • Medullary canal orthopaedic reamer, rigid
BROACH, HIP, TAPERFILL, SIZE 11
Encore Medical, L.P.
803-21-211
In Commercial Distribution

  • 00888912096362 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
CLP STEM MONO BROACH #11
Encore Medical, L.P.
803-08-111
In Commercial Distribution

  • 00888912095075 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
Brush-Frazier Suction 10" 11 Fr
Southmedic Incorporated
PK45911
In Commercial Distribution

  • 00620974003984 ()
  • 10620974003981 ()
PK45911

  • Surgical instrument/endoscope cleaning utensil, reusable
EMPHASYS FEMORAL BROACH SIZE 11
DEPUY (IRELAND)
4840-11-100
In Commercial Distribution

  • 10603295513797 ()
484011100

  • Orthopaedic broach
Frazier Suction 8FR WL 11"
Life Instrument Corporation
791-0008-1C
In Commercial Distribution

  • M93079100081C0 ()


  • Surgical/emergency suction cannula, non-illuminating, reusable
11" American Curette Ang. #7
Life Instrument Corporation
712-1107-1
In Commercial Distribution

  • M930712110710 ()


  • Bone curette, reusable
11" American Curette Str. #7
Life Instrument Corporation
712-1107-0
In Commercial Distribution

  • M930712110700 ()


  • Bone curette, reusable
11" American Curette Ang. #6
Life Instrument Corporation
712-1106-1
In Commercial Distribution

  • M930712110610 ()


  • Bone curette, reusable
11" American Curette Str. #6
Life Instrument Corporation
712-1106-0
In Commercial Distribution

  • M930712110600 ()


  • Bone curette, reusable
11" American Curette #5 Ang
Life Instrument Corporation
712-1105-1
In Commercial Distribution

  • M930712110510 ()


  • Bone curette, reusable
11" American Curette #5 Str
Life Instrument Corporation
712-1105-0
In Commercial Distribution

  • M930712110500 ()


  • Bone curette, reusable
Tapered Suction Tube 11 Fr
Life Instrument Corporation
791-0111-1
In Commercial Distribution

  • M930791011110 ()


  • Surgical/emergency suction cannula, non-illuminating, reusable
Wylie Retractor 1" x 11"
Life Instrument Corporation
745-1011-0-1
In Commercial Distribution

  • M9307451011010 ()


  • Hand-held surgical retractor, reusable
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