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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Curved CoCr Rod, 5.5 X 35
DEGEN MEDICAL, INC.
0115-50035
In Commercial Distribution

  • 00842048103233 ()

  • Length: 35 Millimeter
  • Outer Diameter: 5.5 Millimeter
0115-50035

  • Bone-screw internal spinal fixation system, non-sterile
Straight CoCr Rod, 5.5 X 35
DEGEN MEDICAL, INC.
0116-50035
In Commercial Distribution

  • 00842048103035 ()

  • Length: 35 Millimeter
  • Outer Diameter: 5.5 Millimeter
0116-50035

  • Bone-screw internal spinal fixation system, non-sterile
Straight Ti Rod, 5.5 X 35
DEGEN MEDICAL, INC.
0104-55035
In Commercial Distribution

  • 00842048100034 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 35 Millimeter
0104-55035

  • Bone-screw internal spinal fixation system, non-sterile
Wheelchair Scale 35” X 30 Platform
WELCH ALLYN, INC.
901109
In Commercial Distribution

  • 00732094243925 ()
6702SP

  • Wheelchair-accessible platform scale
NiBP, Disp, Large Adult, 35 - 45
Philips Ds North America LLC
Cuff, NIBP, Disp, Large Adult, 35-45cm
Not in Commercial Distribution

  • 00884838034334 ()
989803170481

  • Blood pressure cuff, reusable
Polyaxial Reduction Screw, 8.0 x 35
CAPTIVA SPINE, INC.
2416-8035
Not in Commercial Distribution

  • M73924168035 ()


  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw, 7.5 x 35
CAPTIVA SPINE, INC.
2416-7535
Not in Commercial Distribution

  • M73924167535 ()


  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw, 6.5 x 35
CAPTIVA SPINE, INC.
2416-6535
Not in Commercial Distribution

  • M73924166535 ()


  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw, 5.5 x 35
CAPTIVA SPINE, INC.
2416-5535
Not in Commercial Distribution

  • M73924165535 ()


  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw, 4.9 x 35
CAPTIVA SPINE, INC.
2416-4935
Not in Commercial Distribution

  • M73924164935 ()


  • Bone-screw internal spinal fixation system, non-sterile
Plate, 3 Level, Size 35 mm
K2M, INC.
8801-43F35
Not in Commercial Distribution

  • 10888857360655 ()

  • Length: 35 Millimeter
8801-43F35

  • Bone-screw internal spinal fixation system, non-sterile
Plate, 2 Level, Size 35 mm
K2M, INC.
8801-42F35
Not in Commercial Distribution

  • 10888857360419 ()

  • Length: 35 Millimeter
8801-42F35

  • Bone-screw internal spinal fixation system, non-sterile
Plate, 1 Level, Size 35 mm
K2M, INC.
8801-41F35
Not in Commercial Distribution

  • 10888857360310 ()

  • Length: 35 Millimeter
8801-41F35

  • Bone-screw internal spinal fixation system, non-sterile
Plate, 2 Level Size 35 mm
K2M, INC.
AA01-42F35V
In Commercial Distribution

  • 10888857401549 ()

  • Length: 35 Millimeter
  • 2 Level
AA01-42F35V

  • Spinal fixation plate, non-bioabsorbable
Plate, 3 Level Size 35 mm
K2M, INC.
8801-43F35G
In Commercial Distribution

  • 10888857399679 ()

  • Length: 35 Millimeter
  • 3 Level
8801-43F35G

  • Spinal fixation plate, non-bioabsorbable
Plate, 2 Level Size 35 mm
K2M, INC.
8801-42F35G
In Commercial Distribution

  • 10888857399433 ()

  • Length: 35 Millimeter
  • 2 Level
8801-42F35G

  • Spinal fixation plate, non-bioabsorbable
Plate, 1 Level Size 35 mm
K2M, INC.
8801-41F35G
In Commercial Distribution

  • 10888857399334 ()

  • Length: 35 Millimeter
  • 1 Level
8801-41F35G

  • Spinal fixation plate, non-bioabsorbable
Plate, 3 Level Size 35 mm
K2M, INC.
AA01-43F35V
In Commercial Distribution

  • 10888857401785 ()

  • Length: 35 Millimeter
  • 3 Level
AA01-43F35V

  • Spinal fixation plate, non-bioabsorbable
Plate, 1 Level Size 35 mm
K2M, INC.
AA01-41F35V
In Commercial Distribution

  • 10888857401440 ()

  • Length: 35 Millimeter
  • 1 Level
AA01-41F35V

  • Spinal fixation plate, non-bioabsorbable
TRIAL RING - 35 DIOPTER NO HANDLE
Fresnel Prism & Lens Company
4000-35NH
In Commercial Distribution

  • 00850029104391 ()
4000-35NH

  • Trial lens set
Wago Matirx Rings Green Qty 35
GoldenDent
WGRU-B
In Commercial Distribution

  • 00850028211946 ()
  • 00850028211328 ()
WGRU-B

  • Dental matrix band retainer
Prevena Peel & Place Dressing- 35 cm
KCI USA, INC.
Prevena Peel & Place Dressing- 35 cm
In Commercial Distribution

  • 00849554006416 ()
  • 00849554006379 ()


  • Negative-pressure wound therapy system, electric, single-use
2304 Immersus Mattress 35"x84"x6"
IMMERSUS HEALTH COMPANY, LLC
Mattress 35"x84"x6"
In Commercial Distribution

  • 00850016369017 ()
2304

  • Foam bed mattress
2303 Immersus Mattress 35"x80"x6"
IMMERSUS HEALTH COMPANY, LLC
Mattress 35"x80"x6"
In Commercial Distribution

  • 00850016369000 ()
2303

  • Foam bed mattress
Angled Disc Wedge, Size 3-5 mm
K2M, INC.
SP-4170-15
In Commercial Distribution

  • 10888857487338 ()

  • Height: 5 Millimeter
SP-4170-15

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Angled Disc Wedge, Size 3-5 mm
K2M, INC.
SP-4165-03
In Commercial Distribution

  • 10888857488335 ()

  • Height: 5 Millimeter
SP-4165-03

  • Orthopaedic prosthesis implantation positioning instrument, reusable
CONNECTOR 5464335 4.75-6.0 TOP LAT 35
MEDTRONIC SOFAMOR DANEK, INC.
5464335
In Commercial Distribution

  • 00643169207035 ()


  • Spinal bone screw, non-bioabsorbable
CONNECTOR 5444335 4.75-4.75 TOP LAT 35
MEDTRONIC SOFAMOR DANEK, INC.
5444335
In Commercial Distribution

  • 00643169206700 ()


  • Spinal bone screw, non-bioabsorbable
CONNECTOR 5464135 4.75-6.0 CLSD LAT 35
MEDTRONIC SOFAMOR DANEK, INC.
5464135
In Commercial Distribution

  • 00643169205215 ()

  • 4.75mm x 6.0mm x 35mm


  • Spinal bone screw, non-bioabsorbable
CONNECTOR 5454135 4.75-5.5 CLSD LAT 35
MEDTRONIC SOFAMOR DANEK, INC.
5454135
In Commercial Distribution

  • 00643169205109 ()

  • Height: 4.75 Millimeter
  • Width: 5.5 Millimeter
  • Length: 35.0 Millimeter


  • Spinal bone screw, non-bioabsorbable
CONNECTOR 5444135 4.75-4.75 CLSD LAT 35
MEDTRONIC SOFAMOR DANEK, INC.
5444135
In Commercial Distribution

  • 00643169204997 ()

  • Length: 35.0 Millimeter


  • Spinal bone screw, non-bioabsorbable
CONNECTOR 5764135 6.35-6.0 CLSD LAT 35
MEDTRONIC SOFAMOR DANEK, INC.
5764135
Not in Commercial Distribution

  • 00643169204881 ()

  • Length: 35.0 Millimeter
  • Width: 6.0 Millimeter
  • Height: 6.35 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
CONNECTOR 5464235 4.75-6.0 SIDE LAT 35
MEDTRONIC SOFAMOR DANEK, INC.
5464235
Not in Commercial Distribution

  • 00643169203884 ()

  • 4.75mm x 6.0mm x 35mm


  • Bone-screw internal spinal fixation system, non-sterile
CONNECTOR 5454235 4.75-5.5 SIDE LAT 35
MEDTRONIC SOFAMOR DANEK, INC.
5454235
In Commercial Distribution

  • 00643169203778 ()

  • Height: 4.75 Millimeter
  • Width: 5.5 Millimeter
  • Length: 35.0 Millimeter


  • Spinal bone screw, non-bioabsorbable
CONNECTOR 5444235 4.75-4.75 SIDE LAT 35
MEDTRONIC SOFAMOR DANEK, INC.
5444235
In Commercial Distribution

  • 00643169203662 ()

  • Width: 4.75 Millimeter
  • Length: 35.0 Millimeter
  • Height: 4.75 Millimeter


  • Spinal bone screw, non-bioabsorbable
CONNECTOR 5764235 6.35-6.0 SIDE LAT 35
MEDTRONIC SOFAMOR DANEK, INC.
5764235
In Commercial Distribution

  • 00643169203556 ()

  • Length: 35.0 Millimeter
  • Height: 4.75 Millimeter
  • Width: 5.5 Millimeter


  • Bone-screw internal spinal fixation system connector
VCR Angular Indicator, Asymmetric Size 35°
K2M, INC.
1902-90021
In Commercial Distribution

  • 10888857025356 ()
1902-90021

  • Orthopaedic prosthesis implantation positioning instrument, reusable
TRIAL 9877709 LORDOTIC 3-HOLE 35/37MM
MEDTRONIC SOFAMOR DANEK, INC.
9877709
In Commercial Distribution

  • 00613994666604 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
Titanium cancellous bone screw, 35 mm
UNITED ORTHOPEDIC CORP.
5201-6735
In Commercial Distribution

  • 04712602344821 ()

  • Length: 35 Millimeter
5201-6735

  • Metal-on-polyethylene total hip prosthesis
Axle Locking Plate Assy, 35, 15mm
Xtant Medical Holdings, Inc.
X060-0067
In Commercial Distribution

  • M697X06000671 ()


  • Interspinous spinal fixation implant
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