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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Tube, Fenestrated, with Slide-On Speaking Valve, Type A, with additional oxygen supply port and additional Inner cannula with 15 mm Connector
Tracoe medical GmbH
REF 888-103-13A-O
Not in Commercial Distribution

  • 04035324021673 ()

  • Lumen/Inner Diameter: 11.8 Millimeter


  • Tracheostomy tube, non-reinforced, non-customized, single-use
Tube, Fenestrated, with Slide-On Speaking Valve, Type A, with additional oxygen supply port and additional Inner cannula with 15 mm Connector
Tracoe medical GmbH
REF 888-103-12A-O
Not in Commercial Distribution

  • 04035324021604 ()

  • Lumen/Inner Diameter: 10.8 Millimeter


  • Tracheostomy tube, non-reinforced, non-customized, single-use
Tube, Fenestrated, with Slide-On Speaking Valve, Type A, with additional oxygen supply port and additional Inner cannula with 15 mm Connector
Tracoe medical GmbH
REF 888-103-11A-O
Not in Commercial Distribution

  • 04035324021543 ()

  • Lumen/Inner Diameter: 9.7 Millimeter


  • Tracheostomy tube, non-reinforced, non-customized, single-use
Tube, Fenestrated, with Slide-On Speaking Valve, Type A, with additional oxygen supply port and additional Inner cannula with 15 mm Connector
Tracoe medical GmbH
REF 888-103-10A-O
Not in Commercial Distribution

  • 04035324021475 ()

  • Lumen/Inner Diameter: 8.7 Millimeter


  • Tracheostomy tube, non-reinforced, non-customized, single-use
Tube, Fenestrated, with Slide-On Speaking Valve, Type A, with additional oxygen supply port and additional Inner cannula with 15 mm Connector
Tracoe medical GmbH
REF 888-103-09A-O
Not in Commercial Distribution

  • 04035324021413 ()

  • Lumen/Inner Diameter: 7.6 Millimeter


  • Tracheostomy tube, non-reinforced, non-customized, single-use
Tube, Fenestrated, with Slide-On Speaking Valve, Type A, with additional oxygen supply port and additional Inner cannula with 15 mm Connector
Tracoe medical GmbH
REF 888-103-08A-O
Not in Commercial Distribution

  • 04035324021352 ()

  • Lumen/Inner Diameter: 6.8 Millimeter


  • Tracheostomy tube, non-reinforced, non-customized, single-use
8 3/4" Jones I.M.A Forceps, Bayonet, Flat Handle, with Platform, 1 x 2 Teeth, with Guide Pin, with Stop, Titanium
Surgical Direct, Inc.
SD902853158
In Commercial Distribution

  • B382SD9028531580 ()
SD902853158

  • Dressing/utility forceps, scissors-like, reusable
ELVAREX 2/BODY BANDAGE WITH LEG EXTENSION/WITH SLIP FORM ON BOTH SIDES WITH ADJUSTABLE WAIST BAND/FLY FOR MEN/COCOA
BSN-Jobst GmbH
77356-00076-00
In Commercial Distribution

  • 04019702423181 ()

  • Pressure 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
Round Handle Stainless Steel Bayonet Bipolar Forcep 8 5/8" (219.08mm) With Irrigation And Insulation, With A With A 2.0mm Tip
TITAN MANUFACTURING INC
263718446090101
In Commercial Distribution

  • 00817914023991 ()

  • Length: 219.08 Millimeter


  • Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
Round Handle Stainless Steel Bayonet Bipolar Forcep 8 5/8" (219.08mm) With Irrigation And Insulation, With A With A 1.5mm Tip
TITAN MANUFACTURING INC
263718446080101
In Commercial Distribution

  • 00817914023984 ()

  • Length: 219.08 Millimeter


  • Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
Round Handle Stainless Steel Bayonet Bipolar Forcep 7 7/8" (200.03mm) With Irrigation And Insulation, With A With A 1.5mm Tip
TITAN MANUFACTURING INC
263718440080101
In Commercial Distribution

  • 00817914023908 ()

  • Length: 200.03 Millimeter


  • Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
Round Handle Stainless Steel Bayonet Bipolar Forcep 7 1/8" (180.98mm) With Irrigation And Insulation, With A With A 2.0mm Tip
TITAN MANUFACTURING INC
263718434090101
In Commercial Distribution

  • 00817914023847 ()

  • Length: 180.98 Millimeter


  • Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
Blue Titanium Jewelers Bipolar Forcep With Fine Serrations 4 3/4" (120.65mm) With A Gold 10mm Area With A 0.4mm Tip
TITAN MANUFACTURING INC
186210215020101
In Commercial Distribution

  • 00817914023373 ()

  • Length: 4.75 Inch


  • Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
M-Style Straight Bipolar Forcep 6 3/4" (171.45mm) With A With A 0.2mm Tip With Stop (*** PRODUCT MAY SCISSOR AT TIPS ***)
TITAN MANUFACTURING INC
163210131000101
In Commercial Distribution

  • 00817914021287 ()

  • Length: 171.45 Millimeter


  • Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
Hardy Bayonet Bipolar Forcep 8 1/2" (215.9mm) With Stop, Insulated With A With A 1.0mm Tip Angled Down 45° Anti-Stick
TITAN MANUFACTURING INC
163028145060501
In Commercial Distribution

  • 00817914020907 ()

  • Length: 8.5 Inch


  • Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
Hardy Bayonet Bipolar Forcep 8 1/2" (215.9mm) With Stop, Insulated With A With A 1.0mm Tip Angled Up 45° Anti-Stick
TITAN MANUFACTURING INC
163028145060401
In Commercial Distribution

  • 00817914020891 ()

  • Length: 8.5 Inch


  • Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
Proprietary bio-compatible patch electrode array with nine Ag/AgCl pads lined with hydrogel. Intended to be used with TrueLabor Maternal Unit.
O.B - TOOLS LTD
FG0003(X)
Not in Commercial Distribution

  • 07290016406030 ()
  • 17290016406037 ()
  • 27290016406034 ()

  • Width: 280 Millimeter
  • Length: 320 Millimeter
FG0003(X)

  • Cardiotocography telemetric monitoring system
MICROBORE INFUSION SET WITH FEMALE LUER LOCK, ADMINISTRATION CASSETTE WITH FREE-FLOW PROTECTION, SLIDE CLAMP AND ONE-WAY CHECKVALVE WITH MALE LUER LOCK
EITAN MEDICAL LTD
12222-000-0004
In Commercial Distribution

  • 17290109152506 ()
  • 27290109152503 ()


  • Electric infusion pump administration set, single-use
PowerPort duo M.R.I. Implantable Port with Attachable 9.5F ChronoFlex Open-Ended Dual-Lumen Venous Catheter with Smooth Septum. Intermediate Kit (with Suture Plugs)
Bard Access Systems, Inc.
5829502
In Commercial Distribution

  • 10801741027403 ()
  • 00801741027406 ()

  • Catheter Gauge: 9.5 French
  • Length: 45 Centimeter
5829502

  • Vascular port/catheter
Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port with Sharps Safety Features for use with 7.5 - 8 Fr. Catheters
TELEFLEX INCORPORATED
IPN035917
In Commercial Distribution

  • 30801902028137 ()
  • 00801902028136 ()
RH-09901

  • Vascular catheter introduction set, nonimplantable
The M5, Single Package with Single Flat Panel Monitor Mount, with Hub, Tandem is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995191405 ()
LM24T

  • Operating room light system
  • Operating room light
  • Medical monitor/light mount
The M5, Single Package with Single Flat Panel Monitor Mount, with Hub Spacer is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995191399 ()
LM24

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The M7 Single Package with Single High Density Flat Panel Monitor with Hub is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995190460 ()
LM29N

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
With Fluid Ciculation - Thermal Balloon Ablation Silicone Catheter with Fluid Circulation. For use only with GYNECARE THERMACHOICE TM UBT System Controller
Ethicon Inc.
TC003
Not in Commercial Distribution

  • 20705031050737 ()
  • 10705031050730 ()
TC003

  • Circulating-fluid endometrial-ablation catheter
microTargeting Insertion Tube with Stylet, nonsterile, at target, for use with Nexframe/Nexdrive
FHC, INC.
66-IT(DB12)-00521
In Commercial Distribution

  • 00873263005217 ()

  • Lumen/Inner Diameter: 1.6 Millimeter
  • Outer Diameter: 1.83 Millimeter
  • Length: 211.6 Millimeter
66-IT(DB12)

  • Intracerebral cannula, implantable
With extra reservoir bag, with B/V filter, 7' tubing w/threaded nut
WESTMED, INC.
0329
In Commercial Distribution

  • 10709078000734 ()
  • 00709078000737 ()


  • Heat/moisture exchanger/microbial medical gas filter
  • Nebulizing system delivery set, single-use
Bitestrong Bite Blocks with Nasal Oxygen Delivery, 18 mm, single use, with stap
Batrik Medical Manufacturing Inc
BO2
In Commercial Distribution

  • 00690521000100 ()
BO2

  • Endoscopic bite block, basic, single-use
Coffee PU leather, With inflation bag, Double tube, With connector Adult Range 25-35cm
Orantech Inc.
BPN-50BD-WD11
In Commercial Distribution

  • 06941691964490 ()


  • Blood pressure cuff, reusable
Coffee PU leather, With inflation bag, Single tube,With connector Adult Range 25-35cm
Orantech Inc.
BPN-50BS-W10
In Commercial Distribution

  • 06941691964292 ()


  • Blood pressure cuff, reusable
Coffee PU leather, With inflation bag, Single tube,With connectorLarge Adult Range 33-47cm
Orantech Inc.
BPN-70BS-W01M
In Commercial Distribution

  • 06941691963400 ()


  • Blood pressure cuff, reusable
Coffee PU leather, With inflation bag, Single tube,With connector Adult Range 25-35cm
Orantech Inc.
BPN-50BS-W01M
In Commercial Distribution

  • 06941691963387 ()


  • Blood pressure cuff, reusable
Coffee PU leather, With inflation bag, Single tube,With connector SmallAdult Range 20-28cm
Orantech Inc.
BPN-40BS-W01M
In Commercial Distribution

  • 06941691963370 ()


  • Blood pressure cuff, reusable
EpiSpin Lock Tuohy with backeye and wings 18G x 90mm, Sprotte Standard with
Pajunk GmbH Medizintechnologie
0021351-30
Not in Commercial Distribution

  • 14048223009410 ()
  • 04048223009413 ()
0021351-30

  • Epidural/intrathecal anaesthesia set, non-medicated
EpiSpin Lock Tuohy with backeye and wings 18G x 90mm, Sprotte Standard with
Pajunk GmbH Medizintechnologie
0011351-30
Not in Commercial Distribution

  • 14048223009342 ()
  • 04048223009345 ()
0011351-30

  • Epidural/intrathecal anaesthesia set, non-medicated
EpiSpin Lock Tuohy with backeye and wings 17G x 90mm Sprotte Standard with
Pajunk GmbH Medizintechnologie
0011351-20
Not in Commercial Distribution

  • 14048223009335 ()
  • 04048223009338 ()
0011351-20

  • Epidural/intrathecal anaesthesia set, non-medicated
EpiSpin Lock Tuohy with backeye and wings 18G x 90mm, Sprotte Standard with
Pajunk GmbH Medizintechnologie
0001351-30
Not in Commercial Distribution

  • 14048223009151 ()
  • 04048223009154 ()
0001351-30

  • Epidural/intrathecal anaesthesia set, non-medicated
Coffee PU leather, With inflation bag, Double tube, With connector Adult Range 25-35cm
Orantech Inc.
BPN-50BD-W1011
In Commercial Distribution

  • 06941691964582 ()


  • Blood pressure cuff, reusable
Coffee PU leather, With inflation bag, Double tube, With connector Adult Range 25-35cm
Orantech Inc.
BPN-50BD-WD08
In Commercial Distribution

  • 06941691964384 ()


  • Blood pressure cuff, reusable
Back w/armrest-padded full length for Stool, complete with hardware, - with uph back
BRYDAN MEDICAL HOLDINGS
90086
In Commercial Distribution

  • 00853301008295 ()


  • Chair/stool armrest
SPUR II Infant with closed reservoir, with no face mask 12 pcs/box
Ambu A/S
540200000
In Commercial Distribution

  • 05707480033843 ()
  • 05707480017928 ()

  • Infant
540200000

  • Pulmonary resuscitator, manual, single-use
Sentrus Insufflation Tubing with CO2 Connector, Insufflation tubing with CO2 connection hose (Olympus)
Yangzhou Fartley Medical Instrument Technology Co., Ltd
FTL-EFC-O-D1-B1
In Commercial Distribution

  • 16936603231163 ()
  • 06936603231166 ()
SEN-INT-O-CO2

  • Endoscopic insufflation tubing set, single-use
Coffee PU, With bag, With connector Double tube Large Adult Long Range 33-47cm
Orantech Inc.
BPN-80BD-W38
In Commercial Distribution

  • 06941691980735 ()


  • Blood pressure cuff, reusable
Safety blood collection set with pre-attached holder, 21G*3/4" with 12" tubing
KB Medical (group), Inc.
SBCN21-1H
In Commercial Distribution

  • 00850016172341 ()


  • Blood collection set, invasive
Safety blood collection set with pre-attached holder, 25G*3/4" with 12" tubing
KB Medical (group), Inc.
SBCN25-1H
In Commercial Distribution

  • 00850016172969 ()


  • Blood collection set, invasive
Perforator Driver with Hudson End, 60:1 Ratio. Use with XMax, eMax Systems.
Synthes GmbH
CSR60
In Commercial Distribution

  • 00845384001782 ()
CSR60

  • Burring power tool attachment
3000CC HIFLOW SUCTION CANISTER WITH AEROSTAT FILTER, FLOAT VALVE SHUTOFF WITH GREEN LID
BEMIS MANUFACTURING COMPANY
72200024
In Commercial Distribution

  • 10073088152791 ()
  • 00073088152794 ()

  • Total Volume: 3000 Milliliter
72200024

  • Surgical suction system collection container, single-use
1200CC HIFLOW SUCTION CANISTER WITH AEROSTAT FILTER, FLOAT VALVE SHUTOFF WITH GREEN LID
BEMIS MANUFACTURING COMPANY
883001
In Commercial Distribution

  • 10073088152784 ()
  • 00073088152787 ()

  • Total Volume: 1200 Milliliter
883001

  • Surgical suction system collection container, single-use
1200CC HIFLOW SUCTION CANISTER WITH AEROSTAT FILTER, FLOAT VALVE SHUTOFF WITH GREEN LID
BEMIS MANUFACTURING COMPANY
484410
In Commercial Distribution

  • 10073088149999 ()
  • 00073088149992 ()

  • Total Volume: 1200 Milliliter
484410

  • Surgical suction system collection container, single-use
1200CC HIFLOW SUCTION CANISTER WITH AEROSTAT FILTER, FLOAT VALVE SHUTOFF WITH WHITE LID
BEMIS MANUFACTURING COMPANY
480410
In Commercial Distribution

  • 10073088149975 ()
  • 00073088149978 ()

  • Total Volume: 1200 Milliliter
480410

  • Surgical suction system collection container, single-use
AF541 Under the Nose Mask with Standard Elbow, with Capstrap, Size C, Japan
Respironics, Inc.
AF541 Mask with SE, Under Nose, w/Capstrap, Size C, JP
Not in Commercial Distribution

  • 30606959041333 ()
  • 00606959041332 ()
1129498

  • CPAP/BPAP face mask, single-use
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