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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1.0MM TI H-PLATE 11 HOLES
Synthes GmbH
420.85
In Commercial Distribution

  • H980420850 ()
  • 10887587049373 ()
42085

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
ADSON RONGUER STRAIGHT 11" LONG
ELMED INCORPORATED
33142-28
In Commercial Distribution

  • 00198506057014 ()
33142-28

  • Craniofacial rongeur, reusable
ELEVATOR, COBB, 11" (28CM), 13MM
ELMED INCORPORATED
ST3374913
In Commercial Distribution

  • 00198506004384 ()
ST3374913

  • Orthopaedic surgical procedure kit, non-medicated, reusable
HEGAR DILATOR SIZE 11/12
ELMED INCORPORATED
ST322612
In Commercial Distribution

  • 00198506000799 ()
ST322612

  • Vaginal dilator
11 Gauge Cement Delivery Cannula
Zavation LLC
VCF-1007-11
In Commercial Distribution

  • 00842166184640 ()


  • Balloon kyphoplasty kit
Sizer, 10 deg, 11&12mm
Zavation LLC
ZAV-1025-08
In Commercial Distribution

  • 00842166179264 ()


  • Polymeric spinal interbody fusion cage
Sizer, 6 deg, 11 & 12mm
Zavation LLC
ZAV-1025-04
In Commercial Distribution

  • 00842166179226 ()


  • Polymeric spinal interbody fusion cage
PLIF-C Ti 11x32 Convex -11
Zavation LLC
107-1132-11
In Commercial Distribution

  • 00842166120754 ()
N/A

  • Polymeric spinal interbody fusion cage
PLIF-C Ti 11x27 Convex -11
Zavation LLC
107-1127-11
In Commercial Distribution

  • 00842166120662 ()
N/A

  • Polymeric spinal interbody fusion cage
PLIF-C Ti 11x23 Convex -11
Zavation LLC
107-1123-11
In Commercial Distribution

  • 00842166120570 ()
N/A

  • Polymeric spinal interbody fusion cage
PLIF-C Ti 9x32 Convex -11
Zavation LLC
107-0932-11
In Commercial Distribution

  • 00842166120488 ()
N/A

  • Polymeric spinal interbody fusion cage
PLIF-C Ti 9x27 Convex -11
Zavation LLC
107-0927-11
In Commercial Distribution

  • 00842166120396 ()
N/A

  • Polymeric spinal interbody fusion cage
PLIF-C Ti 9x23 Convex -11
Zavation LLC
107-0923-11
In Commercial Distribution

  • 00842166120303 ()
N/A

  • Polymeric spinal interbody fusion cage
Spreader Shim, 11 X 16
DEGEN MEDICAL, INC.
12-06S1116
In Commercial Distribution

  • 00842048150244 ()
12-06S1116

  • Bone lever/elevator, reusable
Spreader Shim, 11 X 14
DEGEN MEDICAL, INC.
12-06S1114
In Commercial Distribution

  • 00842048150237 ()
12-06S1114

  • Bone lever/elevator, reusable
Polysomnography Sleep System Version 11
NIHON KOHDEN AMERICA, INC.
A/ONEBED-SCORE-11X
In Commercial Distribution

  • 00841983104008 ()
A/ONEBED-SCORE-11X

  • Sleep disorder interpretive software
WILTSE GELPI RETRACTOR, 11" 1X1
ELMED INCORPORATED
ST2355370
In Commercial Distribution

  • 00842180196940 ()
ST2355370

  • Hand-held surgical retractor, reusable
DEAVER RETRACTOR 1-1/2x12", INSULATED
ELMED INCORPORATED
ST1918738I
In Commercial Distribution

  • 00842180193390 ()
ST1918738I

  • Hand-held surgical retractor, reusable
COBB ELEVATOR 11" W-3/4"
ELMED INCORPORATED
ST15250246
In Commercial Distribution

  • 00842180191990 ()
ST15250246

  • Orthopaedic surgical procedure kit, non-medicated, reusable
HA+CIF 14x16, 0deg, -11
Zavation LLC
642-0011
In Commercial Distribution

  • 00842166156173 ()


  • Polymeric spinal interbody fusion cage
HA+CIF 13x15, 10deg, -11
Zavation LLC
641-1011
In Commercial Distribution

  • 00842166156098 ()


  • Polymeric spinal interbody fusion cage
HA+CIF 13x15, 9deg, -11
Zavation LLC
641-0911
In Commercial Distribution

  • 00842166156012 ()


  • Polymeric spinal interbody fusion cage
HA+CIF 13x15, 8deg, -11
Zavation LLC
641-0811
In Commercial Distribution

  • 00842166155930 ()


  • Polymeric spinal interbody fusion cage
HA+CIF 13x15, 7deg, -11
Zavation LLC
641-0711
In Commercial Distribution

  • 00842166155855 ()


  • Polymeric spinal interbody fusion cage
HA+CIF 13x15, 6deg, -11
Zavation LLC
641-0611
In Commercial Distribution

  • 00842166155770 ()


  • Polymeric spinal interbody fusion cage
HA+CIF 13x15, 5deg, -11
Zavation LLC
641-0511
In Commercial Distribution

  • 00842166155695 ()


  • Polymeric spinal interbody fusion cage
HA+CIF 13x15, 0deg, -11
Zavation LLC
641-0011
In Commercial Distribution

  • 00842166155619 ()


  • Polymeric spinal interbody fusion cage
HA+CIF 12x14, 10deg, -11
Zavation LLC
640-1011
In Commercial Distribution

  • 00842166155534 ()


  • Polymeric spinal interbody fusion cage
HA+CIF 12x14, 9deg, -11
Zavation LLC
640-0911
In Commercial Distribution

  • 00842166155459 ()


  • Polymeric spinal interbody fusion cage
HA+CIF 12x14, 8deg, -11
Zavation LLC
640-0811
In Commercial Distribution

  • 00842166155374 ()


  • Polymeric spinal interbody fusion cage
HA+CIF 12x14, 7deg, -11
Zavation LLC
640-0711
In Commercial Distribution

  • 00842166155299 ()


  • Polymeric spinal interbody fusion cage
HA+CIF 12x14, 6deg, -11
Zavation LLC
640-0611
In Commercial Distribution

  • 00842166155213 ()


  • Polymeric spinal interbody fusion cage
HA+CIF 12x14, 5deg, -11
Zavation LLC
640-0511
In Commercial Distribution

  • 00842166155138 ()


  • Polymeric spinal interbody fusion cage
HA+CIF 12x14, 0deg, -11
Zavation LLC
640-0011
In Commercial Distribution

  • 00842166155053 ()


  • Polymeric spinal interbody fusion cage
11 cm Long Attachment, G1
Synthes GmbH
LONG-G1
In Commercial Distribution

  • 00845384016335 ()
LONG-G1

  • Burring power tool attachment
Mouth Gag "Molt" | 11 cm
devemed GmbH
02-1115-11
In Commercial Distribution

  • 04061644046102 ()


  • Mouth gag, adjustable, reusable
ProStim Electrodes, 1-1/4" Round
ALIMED, INC.
31700
In Commercial Distribution

  • 00733657258363 ()

  • Round
  • Length: 2 Inch
31703

  • Transcutaneous electrical stimulation electrode, single-use
DRILL BIT EX0412217 11 MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0412217
In Commercial Distribution

  • 00643169177222 ()


  • Fluted surgical drill bit, reusable
MODULAR REAMER HEAD DIA 11
ORTHO SOLUTIONS HOLDINGS LIMITED
OS333534
In Commercial Distribution

  • 05055662904987 ()
OS333534

  • Medullary canal orthopaedic reamer, rigid
3.5MM A.C.P. PLATE 11 HOLE
ORTHO SOLUTIONS HOLDINGS LIMITED
OS481011
In Commercial Distribution

  • 05055662901481 ()
  • 05055662901498 ()
OS481011

  • Orthopaedic fixation plate, non-bioabsorbable
Bathmate Hydroxtreme 11 Crystal Clear
DX PRODUCTS LIMITED
Hydroxtreme 11 CC
In Commercial Distribution

  • 05060140209232 ()
  • 05060140209225 ()

  • Lumen/Inner Diameter: 2.7 Inch
  • Depth: 11 Inch
BM-HX11-CC

  • Penile vacuum device
Q-Collar, Grey/Grey, Size 11
Q30 Sports Science, LLC
207200-11
In Commercial Distribution

  • 00850038401399 ()


  • Traumatic brain injury protection compression collar
Q-Collar, Tactical, Blackout, Size 11
Q30 Sports Science, LLC
205071-11
In Commercial Distribution

  • 00850038401085 ()


  • Traumatic brain injury protection compression collar
Q-Collar, Tactical, MultiCam, Size 11
Q30 Sports Science, LLC
205072-11
In Commercial Distribution

  • 00850038401160 ()


  • Traumatic brain injury protection compression collar
Grafting Instrument Kit (11 Instruments)
GoldenDent
GO GKI
In Commercial Distribution

  • 00850011211946 ()
GO GKI

  • Bone file/rasp, manual, reusable
  • Suture scissors
  • Bone curette, reusable
  • Suturing needle holder, reusable
  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
  • Periodontal knife
  • Periosteal elevator, reusable
  • Scalpel handle, reusable
  • Dappen dish, reusable
ClearPoint Neuro Workstation - Win 11
Clearpoint Neuro, Inc.
CP-WRK-WIN11
In Commercial Distribution

  • 00850047354136 ()
CP-WRK-WIN11

  • Neurological stereotactic surgery system
Disc Scraper Size 11 mm
K2M, INC.
SP-4031-06
In Commercial Distribution

  • 10888857515215 ()

  • Height: 11 Millimeter
SP-4031-06

  • Bone curette, reusable
Spreader, Size 11 mm, 8°
K2M, INC.
SP-4127-06
In Commercial Distribution

  • 10888857468368 ()

  • Angle: 8 degree
  • Height: 11 Millimeter
SP-4127-06

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Disc Spreader, Size 11 mm
K2M, INC.
SP-4193-05
In Commercial Distribution

  • 10888857481657 ()

  • Height: 11 Millimeter
SP-4193-05

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Box Chisel, Size 11 mm
K2M, INC.
SP-4013-05
In Commercial Distribution

  • 10888857469167 ()

  • Height: 11 Millimeter
SP-4013-05

  • Orthopaedic prosthesis implantation positioning instrument, reusable
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