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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With inflation bag, Single tube, With connector Adult Range 23-33cm
Orantech Inc.
BP-50BS-W11
In Commercial Distribution

  • 06970706368794 ()


  • Blood pressure cuff, reusable
With inflation bag, Single tube, With connector Child Range 12-19cm
Orantech Inc.
BP-30BS-W11
In Commercial Distribution

  • 06970706368770 ()


  • Blood pressure cuff, reusable
With inflation bag, Single tube, With connector Infant Range 8-13cm
Orantech Inc.
BP-20BS-W11
In Commercial Distribution

  • 06970706368763 ()


  • Blood pressure cuff, reusable
With inflation bag, Single tube, With connector Neonatal Range 6-11cm
Orantech Inc.
BP-10BS-W11
In Commercial Distribution

  • 06970706368756 ()


  • Blood pressure cuff, reusable
With inflation bag, Single tube, With connector Thigh Range 38-50cm
Orantech Inc.
BP-90BS-W10
In Commercial Distribution

  • 06970706368749 ()


  • Blood pressure cuff, reusable
With inflation bag, Single tube, With connector Adult Range 23-33cm
Orantech Inc.
BP-50BS-W10
In Commercial Distribution

  • 06970706368701 ()


  • Blood pressure cuff, reusable
With inflation bag, Single tube, With connector Child Range 12-19cm
Orantech Inc.
BP-30BS-W10
In Commercial Distribution

  • 06970706368688 ()


  • Blood pressure cuff, reusable
With inflation bag, Single tube, With connector Infant Range 8-13cm
Orantech Inc.
BP-20BS-W10
In Commercial Distribution

  • 06970706368671 ()


  • Blood pressure cuff, reusable
With inflation bag, Single tube, With connector Neonatal Range 6-11cm
Orantech Inc.
BP-10BS-W10
In Commercial Distribution

  • 06970706368664 ()


  • Blood pressure cuff, reusable
With inflation bag, Single tube, With connector Thigh Range 38-50cm
Orantech Inc.
BP-90BS-W08
In Commercial Distribution

  • 06970706368657 ()


  • Blood pressure cuff, reusable
With inflation bag, Single tube, With connector Adult Range 23-33cm
Orantech Inc.
BP-50BS-W08
In Commercial Distribution

  • 06970706368619 ()


  • Blood pressure cuff, reusable
With inflation bag, Single tube, With connector Child Range 12-19cm
Orantech Inc.
BP-30BS-W08
In Commercial Distribution

  • 06970706368596 ()


  • Blood pressure cuff, reusable
With inflation bag, Single tube, With connector Infant Range 8-13cm
Orantech Inc.
BP-20BS-W08
In Commercial Distribution

  • 06970706368589 ()


  • Blood pressure cuff, reusable
With inflation bag, Single tube, With connector Neonatal Range 6-11cm
Orantech Inc.
BP-10BS-W08
In Commercial Distribution

  • 06970706368572 ()


  • Blood pressure cuff, reusable
With inflation bag, Single tube, With connector Thigh Range 38-50cm
Orantech Inc.
BP-90BS-W03P
In Commercial Distribution

  • 06970706368565 ()


  • Blood pressure cuff, reusable
With inflation bag, Single tube, With connector Child Range 12-19cm
Orantech Inc.
BP-30BS-W03P
In Commercial Distribution

  • 06970706368503 ()


  • Blood pressure cuff, reusable
With inflation bag, Single tube, With connector Infant Range 8-13cm
Orantech Inc.
BP-20BS-W03P
In Commercial Distribution

  • 06970706368497 ()


  • Blood pressure cuff, reusable
With inflation bag, Single tube, With connector Neonatal Range 6-11cm
Orantech Inc.
BP-10BS-W03P
In Commercial Distribution

  • 06970706368480 ()


  • Blood pressure cuff, reusable
With inflation bag, Single tube, With connector Thigh Range 38-50cm
Orantech Inc.
BP-90BS-W01M
In Commercial Distribution

  • 06970706368473 ()


  • Blood pressure cuff, reusable
With inflation bag, Single tube, With connector Adult Range 23-33cm
Orantech Inc.
BP-50BS-W01M
In Commercial Distribution

  • 06970706368435 ()


  • Blood pressure cuff, reusable
With inflation bag, Single tube, With connector Child Range 12-19cm
Orantech Inc.
BP-30BS-W01M
In Commercial Distribution

  • 06970706368411 ()


  • Blood pressure cuff, reusable
With inflation bag, Single tube, With connector Infant Range 8-13cm
Orantech Inc.
BP-20BS-W01M
In Commercial Distribution

  • 06970706368404 ()


  • Blood pressure cuff, reusable
With inflation bag, Single tube, With connector Neonatal Range 6-11cm
Orantech Inc.
BP-10BS-W01M
In Commercial Distribution

  • 06970706368398 ()


  • Blood pressure cuff, reusable
Traxi Extender with Retentus Technology (BMI>50 - used with PH-25)
CLINICAL INNOVATIONS, LLC
PRS-0550
In Commercial Distribution

  • 30814247020360 ()
  • 40814247020367 ()


  • Abdominal retractor, hand-held
Dedicated ECG Electrode Belt with Straps. D-Type With Screws Connector
LEVMED LTD
ARs
In Commercial Distribution

  • 07290016423068 ()
A-11061/s-AL

  • Electrocardiographic electrode, reusable
Dedicated ECG Electrode Belt with Handles. D-Type With Screws Connector
LEVMED LTD
ARh
In Commercial Distribution

  • 07290016423051 ()
11061/h-LM

  • Electrocardiographic electrode, reusable
Open Base, PowerXL, Power Table with Adjustable Backrest with casters
CLINTON INDUSTRIES, INC.
80299-087
In Commercial Distribution

  • 00810045932767 ()
8029987

  • Examination/treatment table, line-powered
ZoomScope® with Trulight Colposcope USB Video with 5-legged base
Coopersurgical, Inc.
906043-40TU-5
In Commercial Distribution

  • 00888937013696 ()


  • Colposcope
Ring with support with knob folding Pessary #13; 5" (127mm)
Coopersurgical, Inc.
MXPRSK13
In Commercial Distribution

  • 00888937008937 ()


  • Pelvic-organ-supporting pessary
Ring with support with knob folding Pessary #9; 4" (102mm)
Coopersurgical, Inc.
MXPRSK09
In Commercial Distribution

  • 00888937008890 ()


  • Pelvic-organ-supporting pessary
Ring with support with knob folding Pessary #5; 3" (76mm)
Coopersurgical, Inc.
MXPRSK05
In Commercial Distribution

  • 00888937008852 ()


  • Pelvic-organ-supporting pessary
Ring with support with knob folding Pessary #1; 2" (51mm)
Coopersurgical, Inc.
MXPRSK01
In Commercial Distribution

  • 00888937008814 ()


  • Pelvic-organ-supporting pessary
Insufflation Tubing for use with Laparoscopic Insufflators with 15mm connection
NORTHGATE TECHNOLOGIES INC.
7-510-15
In Commercial Distribution

  • 10817183020308 ()
  • 00817183020301 ()


  • Endoscopic insufflation tubing set, single-use
Homecare Suction, North America with 800CC bottle with External Filter
DEVILBISS HEALTHCARE LLC
7305D-D-EXF
In Commercial Distribution

  • 00885304008866 ()
7305D-D-EXF

  • Airway suction catheter
DRILL BIT WITH AO CONNECTION FOR USE WITH 3.5MM SCREWS
STERILMED, INC.
STR703702
Not in Commercial Distribution

  • 10888551028646 ()
703702

  • Fluted surgical drill bit, single-use
ENTRIFLEX 8FR 36 INCH WITH STYLET and With ENFit Connectors
Cardinal Health 200, LLC
8884720825E
In Commercial Distribution

  • 50192253011652 ()
  • 10192253011654 ()

  • Length: 36 Inch
  • Catheter Gauge: 8 French
  • Weight: 3 Gram
8884720825E

  • Nasoenteral tube
1 x VersaCross Steerable Sheath; 1 x J-Tip Guidewire
Baylis Médicale Cie Inc
VSS85-BD-71L
In Commercial Distribution

  • 00685447004660 ()

  • 72cm 8.5F VersaCross Steerable Sheath with large curve; 180cm J-Tip Guidewire with OD = 0.035 inch


  • Vascular guide-catheter, single-use
1 x VersaCross Steerable Sheath; 1 x J-Tip Guidewire
Baylis Médicale Cie Inc
VSS85-BD-71M
In Commercial Distribution

  • 00685447004653 ()

  • 72cm 8.5F VersaCross Steerable Sheath with medium curve; 180cm J-Tip Guidewire with OD = 0.035 inch


  • Vascular guide-catheter, single-use
1 x VersaCross Steerable Sheath; 1 x J-Tip Guidewire
Baylis Médicale Cie Inc
VSS85-BD-71S
In Commercial Distribution

  • 00685447004646 ()

  • 72cm 8.5F VersaCross Steerable Sheath with small curve; 180cm J-Tip Guidewire with OD = 0.035 inch


  • Vascular guide-catheter, single-use
SPUR II Infant with closed reservoir, with Duraclear face mask size infant, with Manometer 12 pcs/box
Ambu A/S
540212030
In Commercial Distribution

  • 05707480033935 ()
  • 05707480017980 ()

  • Infant
540212030

  • Pulmonary resuscitator, manual, single-use
The G5 Single Variable with Camera with ConnectPoint Express is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995167103 ()
LGH08NCT

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The G5 Single Variable with Camera with ConnectPoint Express is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995167097 ()
LGH08NCP

  • Operating room light system
  • Operating room light
  • Medical monitor/light mount
ECG Input Cable with dedicated ODU Plug with IEC color coding to 3 Leads with Clip connectors
Norav Medical GmbH
C3-C-E-ODU
In Commercial Distribution

  • 04260498564293 ()
C3-C-E-ODU

  • Electrocardiographic lead set, reusable
LASE Endoscopic Discectomy System (Long), with Tubing Set. For use with HO:YAG lasers with a Trimedyne connector.
CLARUS MEDICAL, LLC
1100-010L
In Commercial Distribution

  • B0671100010L0 ()
1100-010L

  • Lumbar decompression procedure kit
LASE Endoscopic Discectomy Set, with Tubing Set. For use with HO:YAG Lasers with a SMA 905 connector.
CLARUS MEDICAL, LLC
1100-002
In Commercial Distribution

  • B06711000020 ()
1100-002

  • Lumbar decompression procedure kit
Extra-Long Tube, Fenestrated, with Swivel Speaking Valve, Type B, with additional Inner cannula with 15 mm Connector
Tracoe medical GmbH
REF 204-14A
Not in Commercial Distribution

  • 04035324028412 ()

  • Lumen/Inner Diameter: 12.6 Millimeter


  • Tracheostomy tube, non-reinforced, non-customized, single-use
Extra-Long Tube, Fenestrated, with Swivel Speaking Valve, Type B, with additional Inner cannula with 15 mm Connector
Tracoe medical GmbH
REF 204-13A
Not in Commercial Distribution

  • 04035324028115 ()

  • Lumen/Inner Diameter: 11.8 Millimeter


  • Tracheostomy tube, non-reinforced, non-customized, single-use
Extra-Long Tube, Fenestrated, with Swivel Speaking Valve, Type B, with additional Inner cannula with 15 mm Connector
Tracoe medical GmbH
REF 204-12A
In Commercial Distribution

  • 04035324027811 ()

  • Lumen/Inner Diameter: 10.0 Millimeter
REF 204-12A

  • Tracheostomy tube, non-reinforced, non-customized, reusable
Extra-Long Tube, Fenestrated, with Swivel Speaking Valve, Type B, with additional Inner cannula with 15 mm Connector
Tracoe medical GmbH
REF 204-11A
In Commercial Distribution

  • 04035324027514 ()

  • Lumen/Inner Diameter: 9.2 Millimeter
REF 204-11A

  • Tracheostomy tube, non-reinforced, non-customized, reusable
Extra-Long Tube, Fenestrated, with Swivel Speaking Valve, Type B, with additional Inner cannula with 15 mm Connector
Tracoe medical GmbH
REF 204-10A
In Commercial Distribution

  • 04035324027118 ()

  • Lumen/Inner Diameter: 8.8 Millimeter
REF 204-10A

  • Tracheostomy tube, non-reinforced, non-customized, reusable
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