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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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TRACOE comfort - 04035324017744

Extra-Long Tube, with 2 Inner cannula with 15 mm Connector, one Fenestrated and with clamp below
Tracoe medical GmbH
REF 215-12-2
In Commercial Distribution

  • 04035324017744 ()

  • Lumen/Inner Diameter: 10.0 Millimeter
REF 215-12-2

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

TRACOE comfort - 04035324017737

Extra-Long Tube, with 2 Inner cannula with 15 mm Connector, one Fenestrated and with clamp below
Tracoe medical GmbH
REF 215-11-2
In Commercial Distribution

  • 04035324017737 ()

  • Lumen/Inner Diameter: 9.2 Millimeter
REF 215-11-2

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

TRACOE comfort - 04035324017720

Extra-Long Tube, with 2 Inner cannula with 15 mm Connector, one Fenestrated and with clamp below
Tracoe medical GmbH
REF 215-10-2
In Commercial Distribution

  • 04035324017720 ()

  • Lumen/Inner Diameter: 8.8 Millimeter
REF 215-10-2

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

TRACOE comfort - 04035324017706

Extra-Long Tube, with 2 Inner cannula with 15 mm Connector, one Fenestrated and with clamp below
Tracoe medical GmbH
REF 215-09-2
In Commercial Distribution

  • 04035324017706 ()

  • Lumen/Inner Diameter: 7.5 Millimeter
REF 215-09-2

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

TRACOE comfort - 04035324017690

Extra-Long Tube, with 2 Inner cannula with 15 mm Connector, one Fenestrated and with clamp below
Tracoe medical GmbH
REF 215-08-2
In Commercial Distribution

  • 04035324017690 ()

  • Lumen/Inner Diameter: 6.7 Millimeter
REF 215-08-2

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

TRACOE comfort - 04035324017683

Extra-Long Tube, with 2 Inner cannula with 15 mm Connector, one Fenestrated and with clamp below
Tracoe medical GmbH
REF 215-07-2
In Commercial Distribution

  • 04035324017683 ()

  • Lumen/Inner Diameter: 6.0 Millimeter
REF 215-07-2

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

TRACOE comfort - 04035324017676

Extra-Long Tube, with 2 Inner cannula with 15 mm Connector, one Fenestrated and with clamp below
Tracoe medical GmbH
REF 215-06-2
In Commercial Distribution

  • 04035324017676 ()

  • Lumen/Inner Diameter: 5.0 Millimeter
REF 215-06-2

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

TRACOE comfort - 04035324017669

Extra-Long Tube, with 2 Inner cannula with 15 mm Connector, one Fenestrated and with clamp below
Tracoe medical GmbH
REF 215-05-2
In Commercial Distribution

  • 04035324017669 ()

  • Lumen/Inner Diameter: 4.0 Millimeter
REF 215-05-2

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

Black & Black Surgical - 00840329832094

TEBBETTS RETRACTOR; 15CM X 24MM BLADE WITH TEETH, WITH SUCTION, WITHOUT FIBER OPTICS, WITH SILICONE HANDLE
BLACK & BLACK SURGICAL, INC.
B62099
In Commercial Distribution

  • 00840329832094 ()
B62099

  • Hand-held surgical retractor, reusable

Black & Black Surgical - 00840329832087

TEBBETTS RETRACTOR; 9CM X 24MM BLADE WITH TEETH, WITH SUCTION, WITHOUT FIBER OPTICS, WITH SILICONE HANDLE
BLACK & BLACK SURGICAL, INC.
B62098
In Commercial Distribution

  • 00840329832087 ()
B62098

  • Hand-held surgical retractor, reusable

JOBST Elvarex - 04019702303315

Elvarex 2/Glove to elbow/With Finger, with Thumb/Dotted silicone band inside, with zipper/Black
BSN-Jobst GmbH
77359-00064-00
In Commercial Distribution

  • 04019702303315 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable

JOBST Elvarex - 04019702299205

Elvarex 1/Arm sleeve with bias top end and glove, one piece/With Finger, with Thumb
BSN-Jobst GmbH
77328-00005-00
In Commercial Distribution

  • 04019702299205 ()

  • Pressure: 15-21 mmHg


  • Compression/pressure sock/stocking, reusable

JOBST Elvarex - 04019702338300

Elvarex 2/Arm sleeve with bias top end and glove, one piece/With Finger, with Thumb
BSN-Jobst GmbH
77361-00005-00
In Commercial Distribution

  • 04019702338300 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable

JOBST Elvarex - 04019702541489

ELVAREX 1/GLOVE TO ELBOW/WITH FINGER, WITH THUMB/DOTTED SILICONE BAND INSIDE, WITH ZIPPER/HONEY
BSN-Jobst GmbH
77326-00132-00
In Commercial Distribution

  • 04019702541489 ()

  • Pressure 15-21 mmHg


  • Compression/pressure sock/stocking, reusable

Gimmi - 04049047101734

CABLE FOR BIPOLAR INSTRUMENTS WITH FLAT PLUG, 5 MTR., WITH GENERATOR CONNECTION WITH 2 BANANA PLUGS
Gimmi GmbH
T.5768.17
In Commercial Distribution

  • 04049047101734 ()
T.5768.17

  • Electrical-only medical device connection cable, reusable

LASE Endoscopic Discectomy Set - B06711000100

LASE Endoscopic Discectomy System, with Tubing Set. For use with HO:YAG lasers with a Trimedyne connector.
CLARUS MEDICAL, LLC
1100-010
In Commercial Distribution

  • B06711000100 ()
1100-010

  • Lumbar decompression procedure kit

Surgical Direct - B382SD89319000

5mm 32cm Wave Grasper with Ripple Claw Forcep, with Monopolar Rotating Non Locking Handle with Flush
Surgical Direct, Inc.
SD8931-900
In Commercial Distribution

  • B382SD89319000 ()
SD8931-900

  • Laparoscopic tissue manipulation forceps/working-channel

Surgical Direct - B382SD14908330

5mm 45cm Biopsy Spoon Forceps, With Teeth, with Locking Reinforced, Carbon Fiber Handle, Rotating with Ratchet
Surgical Direct, Inc.
SD14908-33
In Commercial Distribution

  • B382SD14908330 ()
SD14908-33

  • Flexible endoscopic tissue manipulation forceps, single-use

Surgical Direct - B382SD14128350

5mm Standard Length Maryland Dissector, with Diamond Serrations, with Locking Reinforced, Carbon Fiber Handle, with Flushport.
Surgical Direct, Inc.
SD14128-35
In Commercial Distribution

  • B382SD14128350 ()

  • Length: 32 Centimeter
  • Outer Diameter: 5 Millimeter
SD14128-35

  • Endoscope sheath, reusable

Titan - 00817914021270

M-Micro Straight Bipolar Forcep 5 1/2" (139.7mm) With A With A 0.75mm Tip With Stop
TITAN MANUFACTURING INC
163210121050101
In Commercial Distribution

  • 00817914021270 ()

  • Length: 5.5 Inch


  • Open-surgery electrosurgical handpiece/electrode, bipolar, reusable

Titan - 00817914020792

Hardy Bayonet Bipolar Forcep 8 1/2" (215.9mm) With A With A 0.5mm Tip With Stop
TITAN MANUFACTURING INC
163010145030101
In Commercial Distribution

  • 00817914020792 ()

  • Length: 8.5 Inch


  • Open-surgery electrosurgical handpiece/electrode, bipolar, reusable

Titan - 00817914020365

Semkin Straight Bipolar Forcep 6" (152.4mm) Insulated With A With A 1.5mm Tip With Travel Stop
TITAN MANUFACTURING INC
161618125080101
In Commercial Distribution

  • 00817914020365 ()

  • Length: 6 Inch


  • Open-surgery electrosurgical handpiece/electrode, bipolar, reusable

Smart VIdeo-Stylet Monitor - B881SSCNDK0

Monitor with connecting and re-charging cables, to be used with video-stylet (comes with IV pole mount)
SMART VIDEO-STYLET, LLC
S-SC-NDK
In Commercial Distribution

  • B881SSCNDK0 ()
S-SC-NDK

  • Rigid non-bladed intubation laryngoscope, video

Unimed - 06945664854771

Reusable NIBP Cuff/with ring/Single tube/with inflation bag/Adult(25-35cm)/with BP12 connector/DictumNet
Unimed Medical Supplies, Inc.
UBPC-1
In Commercial Distribution

  • 06945664854771 ()


  • Blood pressure cuff, reusable

Unimed - 06945664869294

Reusable NIBP cuff/with ring/Single Tube/with inflation bag/Adult big(33-47cm)/With BP18 connector
Unimed Medical Supplies, Inc.
U1869HS-C18
In Commercial Distribution

  • 06945664869294 ()


  • Blood pressure cuff, reusable

Unimed - 06945664880039

Reusable NIBP cuff/with ring/Single Tube/with inflation bag/Adult(25-35cm)/2.0M/With BP15 connector
Unimed Medical Supplies, Inc.
U1880HS-2M-C15
In Commercial Distribution

  • 06945664880039 ()


  • Blood pressure cuff, reusable

Unimed - 06945664871457

Reusable NIBP cuff/with ring/Single Tube/with inflation bag/Adult(25-35cm)/1.5M/With BP15 connector
Unimed Medical Supplies, Inc.
U1880HS-1.5M-C15
In Commercial Distribution

  • 06945664871457 ()


  • Blood pressure cuff, reusable

Magrain Conical Pellets with Tan Color Tape, without pack, with Latex - 04955114013186

50 units in single pack
SAKAMURA KENKYUSHO, K.K.
8010155
In Commercial Distribution

  • 04955114013186 ()


  • Ear microsystem seed/pellet

Catheter Mount Tubing; with right angled swivel connector with bronchoscope/suct - 14250105628897

n.a.
VBM Medizintechnik GmbH
65-88-130
In Commercial Distribution

  • 14250105602439 ()
  • 14250105628897 ()
  • 04250105602432 ()

  • Length: 18 cm / Tubing: 13 cm ; 15 mm I.D., 22 mm O.D. / 22 mm I.D. ; bronchoscope / suction cap (5.0 mm)


  • Breathing circuit catheter mount, reusable

Catheter Mount Tubing; with right angled swivel connector with bronchoscope/suct - 14250105628798

n.a.
VBM Medizintechnik GmbH
65-50-130
In Commercial Distribution

  • 24250105628795 ()
  • 14250105628798 ()
  • 04250105602173 ()

  • Length: 17 cm / Tubing: 13 cm ; 15 mm I.D., 22 mm O.D. / 15 mm O.D.


  • Breathing circuit catheter mount, reusable

Surgical aspirator 2.20 m with Yankauer suction tip, with aspiration control - 08052141311684

Surgical aspirator 2.20 m with Yankauer suction tip, with aspiration control (each pack contains 1 adapter - Adat.05)
OMNIA SRL
32.F2044.00
In Commercial Distribution

  • 08052141311677 ()
  • 08052141311684 ()


  • Dental suction system cannula, single-use

AP414-01 MICROBORE WITH NON-VENTED SPIKE, FEMALE LUER LOCK WITH A BCV - 17290109150458

No Description
EITAN MEDICAL LTD
12003-000-0021
In Commercial Distribution

  • 27290109150455 ()
  • 17290109150458 ()
12003-000-0021

  • Electric infusion pump administration set, single-use

RECEPTAL™ 1000ML DISPOSABLE LINER WITH VAC-GARD® WITH POUR SPOUT - 20704411000942

RECEPTAL™ 1000ML DISPOSABLE LINER WITH VAC-GARD® WITH POUR SPOUT
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411000946 ()
  • 20704411000942 ()
  • 00704411000948 ()
430106105

  • General-purpose suction system, vacuum

ProCure - 10840330704844

ProCure Suction Catheter, 6 Fr, 12" Length, Elbow Tracheostomy, 24 Hour, with Caps, with 22mm Flex Adapter, with HME adapter, with Trach Wedge
Twin Med, LLC
1006230
In Commercial Distribution

  • 30840330704848 ()
  • 10840330704844 ()
  • 50840330704842 ()
  • 70840330704846 ()

  • Catheter Gauge: 6 French
  • Outer Diameter: 0.2 Centimeter
  • Length: 12 Inch
1006230

  • Airway suction catheter

JOBST Elvarex - 04019702299571

Elvarex 1/Arm sleeve with bias top end and glove, one piece/With Finger, with Thumb/Dotted silicone band inside, with zipper/Caramel
BSN-Jobst GmbH
77328-00046-00
In Commercial Distribution

  • 04019702299571 ()

  • Pressure: 15-21 mmHg


  • Compression/pressure sock/stocking, reusable

ProCure - 10840330704851

ProCure Suction Catheter, 10 Fr, 16" Length, Elbow Tracheostomy, 24 Hour, with Caps, with 22mm Flex Adapter, with HME adapter, with Trach Wedge
Twin Med, LLC
1006231
In Commercial Distribution

  • 30840330704855 ()
  • 10840330704851 ()
  • 50840330704859 ()
  • 70840330704853 ()

  • Catheter Gauge: 10 French
  • Outer Diameter: 3.33 Centimeter
  • Length: 16 Inch
1006231

  • Airway suction catheter

Speedlock - 00848657005906

Wave Grasper DG, 5mm with atraumatic wave-like serrations with Rat
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
8510-37-R
In Commercial Distribution

  • 00848657005906 ()


  • Rigid endoscopic tissue manipulation forceps, reusable

Speedlock - 00848657005081

Retraction Forceps with atraumatic inner teeth, 5mm, 45cm with Ratchet
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
8512-37-45-R
In Commercial Distribution

  • 00848657005081 ()


  • Rigid endoscopic tissue manipulation forceps, reusable

Speedlock - 00848657002523

Duval, 10mm with axial serrations, 40mm jaws, 45cm with Ratchet
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
8515-41-45-R
In Commercial Distribution

  • 00848657002523 ()


  • Rigid endoscopic tissue manipulation forceps, reusable

Speedlock - 00848657002516

Duval, 10mm with axial serrations, 40mm jaws, 26cm with Ratchet
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
8515-41-26-R
In Commercial Distribution

  • 00848657002516 ()


  • Rigid endoscopic tissue manipulation forceps, reusable

Speedlock - 00848657001434

Biopsy Spoon, 5mm, with teeth double action, 26cm with Ratchet
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
8517-10-26-R
In Commercial Distribution

  • 00848657001434 ()


  • Rigid endoscopic tissue manipulation forceps, reusable

Aveta Waste Bag - 00850006759361

Aveta Waste Bag (with cap), for use with Aveta System
MEDITRINA, INC.
205-2000
In Commercial Distribution

  • 00850006759378 ()
  • 00850006759361 ()
205-2000

  • Surgical tissue/fluid collection bag, non-sterile

N.A. - J011607101000

Slotted screws with pivots for Herbst TS / I with base
DENTAURUM GmbH & Co.KG
607-101-00
In Commercial Distribution

  • J011607101000 ()
  • J011607101001 ()


  • Orthodontic power arm

Orfit Industries - 05420028784907

Pressure Belt with Manual Pump with belt of 120 cm
Orfit Industries NV
32317/9
In Commercial Distribution

  • 05420028784907 ()


  • Radiological whole-body positioner

Orfit Industries - 05420028755457

Pressure Belt with Manual Pump with belt of 130 cm
Orfit Industries NV
32317/18
In Commercial Distribution

  • 05420028755457 ()


  • Radiological whole-body positioner

SurgiLav - 04546540184634

Plus Handpiece with Multiple-Orifice Tip with Soft Cone Splash Shield
STRYKER CORPORATION
0207559000
In Commercial Distribution

  • 34546540184635 ()
  • 04546540184634 ()
0207559000

  • Disposable surgical irrigation/aspiration system

SurgiLav - 04546540184597

Plus Handpiece with Showerhead Tip with Soft Cone Splash Shield
STRYKER CORPORATION
0207553000
In Commercial Distribution

  • 34546540184598 ()
  • 04546540184597 ()
0207553000

  • Disposable surgical irrigation/aspiration system

Nihon Kohden, EEG-1200A Series Neurofax - 04931921007723

Cart, used with EEG-1200A, works with standard and optional accessories
NIHON KOHDEN CORPORATION
KD-029A-01
In Commercial Distribution

  • 04931921007723 ()
KD-029A-01

  • Instrument trolley

Orfit Industries - 05420028738047

Pressure Belt with Manual Pump with belt of 175 cm
Orfit Industries NV
32317/28
In Commercial Distribution

  • 05420028738047 ()


  • Radiological whole-body positioner

Speedlock - 00848657072755

Speedlock Grasper, 5mm with spoon, pointed version, 45cm, with ratchet
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
8510-25-45-R
In Commercial Distribution

  • 00848657072755 ()


  • Rigid endoscopic tissue manipulation forceps, reusable
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