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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Synthetic bone void filler for orthopedic applications
NOVABONE PRODUCTS, LLC
NB5835
In Commercial Distribution

  • 00813909012926 ()

  • 8x9.4x25mm
NB5835

  • Bone matrix implant, synthetic, non-antimicrobial
PACKED, LUX 35 DETECTOR, 3543
CARESTREAM HEALTH, INC.
Lux 35 Detector
In Commercial Distribution

  • 60889975950570 ()
AK7294

  • Indirect flat panel x-ray detector
1 unit
NUSMILE, LTD.
UDPL357001
In Commercial Distribution

  • 00810092938767 ()


  • Manual non-rotary dental instrument handle
The XO Cross device is a support catheter intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
ZIEN MEDICAL TECHNOLOGIES, INC.
C35-175-H
In Commercial Distribution

  • B090C35175H1 ()
  • B090C35175H0 ()
  • B090C35175H2 ()

  • Catheter Gauge: 3.9 French
  • Crossing Profile: 3.2 French
  • Catheter Working Length: 175 Centimeter
  • Introducer Sheath Compatibility: 4 French
C35-175-H

  • Vascular guide-catheter, single-use
The XO Cross device is a support catheter intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
ZIEN MEDICAL TECHNOLOGIES, INC.
C35-135-H
In Commercial Distribution

  • B090C35135H1 ()
  • B090C35135H0 ()
  • B090C35135H2 ()

  • Catheter Gauge: 3.9 French
  • Crossing Profile: 3.2 French
  • Catheter Working Length: 135 Centimeter
  • Introducer Sheath Compatibility: 4 French
C35-135-H

  • Vascular guide-catheter, single-use
The XO Cross device is a support catheter intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
ZIEN MEDICAL TECHNOLOGIES, INC.
C35-135
Not in Commercial Distribution

  • B090C351351 ()
  • B090C351350 ()
  • B090C351352 ()

  • Catheter Gauge: 3.9 French
  • Catheter Working Length: 135 Centimeter
  • Crossing Profile: 3.2 French
  • Introducer Sheath Compatibility: 4 French
C35-135

  • Vascular guide-catheter, single-use
The XO Cross device is a support catheter intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
ZIEN MEDICAL TECHNOLOGIES, INC.
C35-090-H
In Commercial Distribution

  • B090C35090H1 ()
  • B090C35090H0 ()
  • B090C35090H2 ()

  • Catheter Gauge: 3.9 French
  • Catheter Working Length: 90 Centimeter
  • Introducer Sheath Compatibility: 4 French
  • Crossing Profile: 3.2 French
C35-090-H

  • Vascular guide-catheter, single-use
SSP HLA-B*35; 3 test kit
CareDx AB
101.522-03u
In Commercial Distribution

  • 07340035504689 ()


  • HLA class I antigen tissue typing IVD, kit, multiplex
SSP HLA-B*35; 24 test kit
CareDx AB
101.522-24u
In Commercial Distribution

  • 07340035504665 ()


  • HLA class I antigen tissue typing IVD, kit, multiplex
Decellularized Pulmonary Artery Patch - Thin
LIFENET HEALTH
DPPGN3526
In Commercial Distribution

  • 00889858618496 ()

  • Length: 35 Millimeter
  • Width: 26 Millimeter
DPPGN

  • Cadaveric pulmonary artery bioprosthesis
Decellularized Pulmonary Artery Patch - Thick
LIFENET HEALTH
DPPGK3526
In Commercial Distribution

  • 00889858616294 ()

  • Length: 35 Millimeter
  • Width: 26 Millimeter
DPPGK

  • Cadaveric pulmonary artery bioprosthesis
RESECTOSCOPE OUTER SHEATH 26 CH, FOR 26 / 24 CH RESECTOSCOPE
Gimmi GmbH
T.9525.27
In Commercial Distribution

  • 04049047107996 ()
T.9525.27

  • Endoscope sheath, reusable
dentaform® Snap Band, tooth 26,size 26/Roth 22
DENTAURUM GmbH & Co.KG
879-326-22
In Commercial Distribution

  • J011879326220 ()


  • Orthodontic metal band
dentaform® Snap Band, tooth 26,size 26/Roth 18
DENTAURUM GmbH & Co.KG
879-326-18
In Commercial Distribution

  • J011879326180 ()


  • Orthodontic metal band
dentaform® Snap Band, Tooth 26, Size 26/Roth 22
DENTAURUM GmbH & Co.KG
879-026-22
Not in Commercial Distribution

  • J011879026220 ()


  • Orthodontic metal band
dentaform® Snap Band, Tooth 26, Size 26/Roth 18
DENTAURUM GmbH & Co.KG
879-026-18
Not in Commercial Distribution

  • J011879026180 ()


  • Orthodontic metal band
35 cm / 14 inch
VBM Medizintechnik GmbH
20-64-611
In Commercial Distribution

  • 04250105630107 ()
  • 14250105630104 ()
  • 04250105619799 ()

  • Length: 35 Centimeter
  • Length: 14 Inch


  • Tourniquet cuff, reusable
35 cm / 14 inch
VBM Medizintechnik GmbH
20-75-711
In Commercial Distribution

  • 04250105628999 ()
  • 14250105628996 ()

  • Length: 14 Inch
  • Length: 35 Centimeter


  • Tourniquet cuff, reusable
Angled Awl, 35 Deg
Seaspine Orthopedics Corporation
SR-1039
In Commercial Distribution

  • 10889981309626 ()
SR-1039

  • Bone awl, reusable
SAMPLE U-ETCH 35% CE
ULTRADENT PRODUCTS, INC.
S163-CE
In Commercial Distribution

  • 00883205019509 ()
S163-CE

  • Dental etching solution
ORION TEMPLATE L=35
MEDTRONIC SOFAMOR DANEK, INC.
X1294-135
In Commercial Distribution

  • 00673978155784 ()


  • Surgical implant template, reusable
Vaginal Applicator 35 mm
Icad, Inc.
720270
In Commercial Distribution

  • 00858012005502 ()
AG3035

  • Intraoperative/postoperative therapeutic x-ray system vaginal applicator
MedSurg Overlay (35" Wide)
DABIR SURFACES, INC.
DA-3S3584-05-0H
In Commercial Distribution

  • 00851343006729 ()

  • Length: 84 Inch
  • Width: 35 Inch
  • 5' Tubing


  • Alternating-pressure bed mattress overlay, reusable
MedSurg Overlay (35" Wide)
DABIR SURFACES, INC.
DA-3S3584-01-0H
In Commercial Distribution

  • 00851343006712 ()

  • Length: 84 Inch
  • Width: 35 Inch
  • 1' Tubing


  • Alternating-pressure bed mattress overlay, reusable
SET PEN 35 LABELS
MEDLINE INDUSTRIES, INC.
DYNJCATHLBL1
In Commercial Distribution

  • 10889942792467 ()
  • 40889942792468 ()
DYNJCATHLBL1

  • General surgical procedure kit, non-medicated, single-use
SCALERS JACQUETTE J34/35
Power Dental U.S.A. Inc.
1215
In Commercial Distribution

  • D94312150 ()
1215

  • Dental excavator, reusable
  • Manual dental scaler, reusable
6.0mm Straight Rod, 35
Zavation LLC
381-S035
In Commercial Distribution

  • 00842166196261 ()


  • Orthopaedic bone screw (non-sliding)
5.5mm Straight Rod, 35
Zavation LLC
380-S035
In Commercial Distribution

  • 00842166196001 ()


  • Orthopaedic bone screw (non-sliding)
EQ-S TIP 35/02
META SYSTEMS CO., LTD.
126-250
In Commercial Distribution

  • 08809455600597 ()


  • Root canal irrigation handpiece
Cylinder, Ø 35 mm
Nucletron B.V.
084324P01-03
In Commercial Distribution

  • 08717213008502 ()
  • 08717213041912 ()

  • Device Size Text, specify:
  • Outer Diameter: 35.0 Millimeter


  • Vaginal brachytherapy system applicator, remote-afterloading
Sponge Holder, 35 cm
Karl Storz GmbH & Co. KG
10387B
In Commercial Distribution

  • 04048551048252 ()


  • Dressing/utility forceps, scissors-like, reusable
Cotton Carrier, 35 cm
Karl Storz GmbH & Co. KG
10384B
In Commercial Distribution

  • 04048551048108 ()


  • Flexible endoscopic sponge/swab forceps
Guiding Rod, 35 cm
Karl Storz GmbH & Co. KG
28124BY
In Commercial Distribution

  • 04048551093887 ()


  • Endoscope sheath, reusable
HEDSTROM FILES 31MM 35
ROYDENT DENTAL PRODUCTS INC
06328035R
In Commercial Distribution

  • D80907331035R0 ()
  • D80907331035R1 ()
07331035R

  • Rotary/reciprocating endodontic file/rasp, single-use
HEDSTROM FILES 28MM 35
ROYDENT DENTAL PRODUCTS INC
06325165R
In Commercial Distribution

  • D80907328035R0 ()
  • D80907328035R1 ()
07328035R

  • Rotary/reciprocating endodontic file/rasp, single-use
HEDSTROM FILES 25MM 35
ROYDENT DENTAL PRODUCTS INC
06321165R
In Commercial Distribution

  • D80907325035R0 ()
  • D80907325035R1 ()
07325035R

  • Rotary/reciprocating endodontic file/rasp, single-use
HEDSTROM FILES 21MM 35
ROYDENT DENTAL PRODUCTS INC
06319160R
In Commercial Distribution

  • D80907321035R0 ()
  • D80907321035R1 ()
07321035R

  • Rotary/reciprocating endodontic file/rasp, single-use
KIT, CANISTER, 35 CS
Cardinal Health 200, LLC
CANOC5103E
In Commercial Distribution

  • 50885425991103 ()
  • 10885425991105 ()
CANOC5103E

  • General surgical procedure kit, non-medicated, single-use
3-Level Plate, Size 35
DEGEN MEDICAL, INC.
0210-3035T
In Commercial Distribution

  • 00842048107590 ()

  • Length: 35 Millimeter
0210-3035T

  • Spinal fixation plate, non-bioabsorbable
ZENITH,PLATE,2Level,35
Choice Spine, LP
FT20-E335
In Commercial Distribution

  • 00840996115889 ()

  • Length: 35 Millimeter


  • Spinal fixation plate, non-bioabsorbable
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