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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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NexSite HD Hemodialysis Catheter - 05391525640082

The NexSite™ HD, Hemodialysis Catheter for long term use is a dual lumen, stepped tip radiopaque polyurethane catheter which contains a Dacron biomaterial cuff and two female luer connectors. The DISC (Dermal Ingrowth Support Collar) assists with the direction of the catheter and consists of a biomaterial tissue ingrowth scaffold. The biomaterial scaffolds on the catheter shaft and DISC are aligned and facilitate tissue ingrowth, which is considered important in reducing the source of extraluminal infection in patients requiring long term catheterisation. The Catheter, DISC and the following ancillary components required for the procedure (0.038” guidewire, Stainless Steel Tunneler and Sleeve, 16Fr Introducer / Dilator, Coring Scalpel and Luer Caps) are provided in a tray, sealed with a Tyvek lid and placed in a second sterile pouch so that the tray can be delivered to the sterile field
MARVAO MEDICAL DEVICES LIMITED
NEXHD1554001
In Commercial Distribution

  • 05391525640099 ()
  • 05391525640082 ()

  • Length: 40 Centimeter
NEXHD1554001

  • Double-lumen haemodialysis catheter, implantable

NexSite HD Hemodialysis Catheter - 05391525640068

The NexSite™ HD, Hemodialysis Catheter for long term use is a dual lumen, stepped tip radiopaque polyurethane catheter which contains a Dacron biomaterial cuff and two female luer connectors. The DISC (Dermal Ingrowth Support Collar) assists with the direction of the catheter and consists of a biomaterial tissue ingrowth scaffold. The biomaterial scaffolds on the catheter shaft and DISC are aligned and facilitate tissue ingrowth, which is considered important in reducing the source of extraluminal infection in patients requiring long term catheterisation. The Catheter, DISC and the following ancillary components required for the procedure (0.038” guidewire, Stainless Steel Tunneler and Sleeve, 16Fr Introducer / Dilator, Coring Scalpel and Luer Caps) are provided in a tray, sealed with a Tyvek lid and placed in a second sterile pouch so that the tray can be delivered to the sterile field
MARVAO MEDICAL DEVICES LIMITED
NEXHD1553601
In Commercial Distribution

  • 05391525640075 ()
  • 05391525640068 ()

  • Length: 36 Centimeter
NEXHD1553601

  • Double-lumen haemodialysis catheter, implantable

NexSite HD Hemodialysis Catheter - 05391525640044

The NexSite™ HD, Hemodialysis Catheter for long term use is a dual lumen, stepped tip radiopaque polyurethane catheter which contains a Dacron biomaterial cuff and two female luer connectors. The DISC (Dermal Ingrowth Support Collar) assists with the direction of the catheter and consists of a biomaterial tissue ingrowth scaffold. The biomaterial scaffolds on the catheter shaft and DISC are aligned and facilitate tissue ingrowth, which is considered important in reducing the source of extraluminal infection in patients requiring long term catheterisation. The Catheter, DISC and the following ancillary components required for the procedure (0.038” guidewire, Stainless Steel Tunneler and Sleeve, 16Fr Introducer / Dilator, Coring Scalpel and Luer Caps) are provided in a tray, sealed with a Tyvek lid and placed in a second sterile pouch so that the tray can be delivered to the sterile field
MARVAO MEDICAL DEVICES LIMITED
NEXHD1553201
In Commercial Distribution

  • 05391525640051 ()
  • 05391525640044 ()

  • Length: 32 Centimeter
NEXHD1553201

  • Double-lumen haemodialysis catheter, implantable

NexSite HD Hemodialysis Catheter - 05391525640020

The NexSite™ HD, Hemodialysis Catheter for long term use is a dual lumen, stepped tip radiopaque polyurethane catheter which contains a Dacron biomaterial cuff and two female luer connectors. The DISC (Dermal Ingrowth Support Collar) assists with the direction of the catheter and consists of a biomaterial tissue ingrowth scaffold. The biomaterial scaffolds on the catheter shaft and DISC are aligned and facilitate tissue ingrowth, which is considered important in reducing the source of extraluminal infection in patients requiring long term catheterisation. The Catheter, DISC and the following ancillary components required for the procedure (0.038” guidewire, Stainless Steel Tunneler and Sleeve, 16Fr Introducer / Dilator, Coring Scalpel and Luer Caps) are provided in a tray, sealed with a Tyvek lid and placed in a second sterile pouch so that the tray can be delivered to the sterile field
MARVAO MEDICAL DEVICES LIMITED
NEXHD1552801
In Commercial Distribution

  • 05391525640020 ()
  • 05391525640037 ()

  • Length: 28 Centimeter
NEXHD1552801

  • Double-lumen haemodialysis catheter, implantable

NexSite HD Hemodialysis Catheter - 05391525640006

The NexSite™ HD, Hemodialysis Catheter for long term use is a dual lumen, stepped tip radiopaque polyurethane catheter which contains a Dacron biomaterial cuff and two female luer connectors. The DISC (Dermal Ingrowth Support Collar) assists with the direction of the catheter and consists of a biomaterial tissue ingrowth scaffold. The biomaterial scaffolds on the catheter shaft and DISC are aligned and facilitate tissue ingrowth, which is considered important in reducing the source of extraluminal infection in patients requiring long term catheterisation. The Catheter, DISC and the following ancillary components required for the procedure (0.038” guidewire, Stainless Steel Tunneler and Sleeve, 16Fr Introducer / Dilator, Coring Scalpel and Luer Caps) are provided in a tray, sealed with a Tyvek lid and placed in a second sterile pouch so that the tray can be delivered to the sterile field
MARVAO MEDICAL DEVICES LIMITED
NEXHD1552401
In Commercial Distribution

  • 05391525640006 ()
  • 05391525640013 ()

  • Length: 24 Centimeter
NEXHD1552401

  • Double-lumen haemodialysis catheter, implantable

ORTHOSOURCE - D9115574670

Blue Etch 60 ml syringe
ORTHOSOURCE
557-467
In Commercial Distribution

  • D9115574670 ()
  • D911557467601 ()


  • Dental etching solution

ORTHOSOURCE - D9115574660

Green Etch 60 ml syringe
ORTHOSOURCE
557-466
In Commercial Distribution

  • D911557466601 ()
  • D9115574660 ()


  • Dental etching solution

ORTHOSOURCE - D9115574680

Red Etch 60 ml syringe
ORTHOSOURCE
557-468
In Commercial Distribution

  • D911557468601 ()
  • D9115574680 ()


  • Dental etching solution

ATRAMAT - 07500142029769

ATRAMAT PGC25 SURGICAL SUTURE VIOLET USP 3-0 EP 2, 70 CM NEEDLE SG-36 PREMIUM HEAVY TAPER POINT 36 MM 1/2 CIRCLE 36 UNITS
Internacional Farmacéutica, S.A. de C.V.
PGC25
In Commercial Distribution

  • 07500142329760 ()
  • 07500142029769 ()

  • Length: 36 Millimeter
  • USP 3-0 EP 2
SG3603-H

  • Polyester suture, bioabsorbable, monofilament, non-antimicrobial

ATRAMAT - 07500142005046

ATRAMAT POLYESTER SURGICAL SUTURE GREEN USP 2-0 EP 3, 75 CM DOUBLE NEEDLE S-16 PREMIUM TAPER POINT 16 MM 1/2 CIRCLE KIT WITH PLEDGET WITH 6 POUCHES
Internacional Farmacéutica, S.A. de C.V.
POLYESTER
In Commercial Distribution

  • 07500142905049 ()
  • 07500142005046 ()

  • Length: 16 Millimeter
  • USP 2-0 EP 3
S1652/2-75KP6

  • Polyester suture, non-bioabsorbable, multifilament

FaceLake - 00851908007062

The 50EW is a rechargeable pulse oximeter that is designed to accurately measure oxygen saturation (SpO2) and pulse rate through your finger.
LORTE TECHNOLOGIES, INC
CMS-50EW with Bluetooth
In Commercial Distribution

  • 00851908007062 ()


  • Pulse oximeter

Shower Seat - 05707581000751

No Description
Ropox A/S
Foldable, with leg
In Commercial Distribution

  • 05707581000751 ()
40-43011-2

  • Shower seat, non-powered

zuvo - 00850041729084

zuvo 16 with eyespeak, speech generating device
Talk To ME Technologies, LLC
16 with eyespeak
In Commercial Distribution

  • 00850041729084 ()


  • Voice synthesizer/digitizer

zuvo - 00850041729077

zuvo 12 with eyespeak, speech generating device
Talk To ME Technologies, LLC
12 with eyespeak
In Commercial Distribution

  • 00850041729077 ()


  • Voice synthesizer/digitizer

Prosomnus IA MicrO2 with Patient Monitoring - 00863039000447

Obstructive Sleep Apnea Device with twin mated posts and Patient Monitoring
PROSOMNUS SLEEP TECHNOLOGIES
MicrO2 with Monitoring
In Commercial Distribution

  • 00863039000447 ()


  • Mandible-repositioning sleep-disordered breathing orthosis

Epredia - 05051663517904

Rotary Microtome - Accessory
SHANDON DIAGNOSTICS LIMITED
Cool-Cut with STD
In Commercial Distribution

  • 05051663517904 ()
771120

  • Rotary microtome IVD

Epredia - 05051663517898

Rotary Microtome - Accessory
SHANDON DIAGNOSTICS LIMITED
Cool-Cut with UCC
In Commercial Distribution

  • 05051663517898 ()
771110

  • Rotary microtome IVD

Epredia - 05051663010429

No Description
SHANDON DIAGNOSTICS LIMITED
NX70 CRYOSTAR WITH
In Commercial Distribution

  • 05051663010429 ()


  • Cryostat microtome IVD

Epredia - 05051663010382

No Description
SHANDON DIAGNOSTICS LIMITED
NX70 CRYOSTAR WITH
In Commercial Distribution

  • 05051663010382 ()


  • Cryostat microtome IVD

Epredia - 05051663010344

No Description
SHANDON DIAGNOSTICS LIMITED
NX70 CRYOSTAR WITH
In Commercial Distribution

  • 05051663010344 ()


  • Cryostat microtome IVD

Revolution CT - 00840682146319

Revolution CT with Apex edition - Designated System Medical Device
GE MEDICAL SYSTEMS, INC.
with Apex edition
In Commercial Distribution

  • 00840682146319 ()
5826588

  • Full-body CT system

Little Sucker® and Cover - 10812594011365

The Little Sucker/ NeoSucker are indicated to be used as a tip for suction tubing to aspirate fluids from the mouth and nares. The Little Sucker Cover is indicated for use to protect the Little Sucker Device. The Suction Caddy is intended to hold and store a suction device.
Neotech Products LLC
Preemie with Cover
In Commercial Distribution

  • 10812594011365 ()
  • 00812594011368 ()
N204C

  • Airway suction catheter

Ambler Surgical - 00190660127824

Probe with eye, 9'', malleable, sterling silver
AMBLER SURGICAL CORP.
Probe with eye
In Commercial Distribution

  • 00190660127824 ()
44-641

  • Fistula probe

Ambler Surgical - 00190660127817

Probe with eye, 8'', malleable, sterling silver
AMBLER SURGICAL CORP.
Probe with eye
In Commercial Distribution

  • 00190660127817 ()
44-640

  • Fistula probe

Ambler Surgical - 00190660127800

Probe with eye, 8'', malleable, stainless steel
AMBLER SURGICAL CORP.
Probe with eye
In Commercial Distribution

  • 00190660127800 ()
44-630

  • Fistula probe

Ambler Surgical - 00190660127794

Probe with eye, 7'', malleable, sterling silver
AMBLER SURGICAL CORP.
Probe with eye
In Commercial Distribution

  • 00190660127794 ()
44-639

  • Fistula probe

Ambler Surgical - 00190660127787

Probe with eye, 7'', malleable, stainless steel
AMBLER SURGICAL CORP.
Probe with eye
In Commercial Distribution

  • 00190660127787 ()
44-629

  • Fistula probe

Ambler Surgical - 00190660127770

Probe with eye, 6'', malleable, sterling silver
AMBLER SURGICAL CORP.
Probe with eye
In Commercial Distribution

  • 00190660127770 ()
44-638

  • Fistula probe

Ambler Surgical - 00190660127763

Probe with eye, 6'', malleable, stainless steel
AMBLER SURGICAL CORP.
Probe with eye
In Commercial Distribution

  • 00190660127763 ()
44-628

  • Fistula probe

Ambler Surgical - 00190660127756

Probe with eye, 5'', malleable, sterling silver
AMBLER SURGICAL CORP.
Probe with eye
In Commercial Distribution

  • 00190660127756 ()
44-636

  • Fistula probe

Ambler Surgical - 00190660127749

Probe with eye, 5'', malleable, stainless steel
AMBLER SURGICAL CORP.
Probe with eye
In Commercial Distribution

  • 00190660127749 ()
44-626

  • Fistula probe

Ambler Surgical - 00190660127732

Probe with eye, 5 1/2'', malleable, sterling silver
AMBLER SURGICAL CORP.
Probe with eye
In Commercial Distribution

  • 00190660127732 ()
44-637

  • Fistula probe

Ambler Surgical - 00190660127725

Probe with eye, 5 1/2'', malleable, stainless steel
AMBLER SURGICAL CORP.
Probe with eye
In Commercial Distribution

  • 00190660127725 ()
44-627

  • Fistula probe

Ambler Surgical - 00190660127718

Probe with eye, 4 1/2'', malleable, sterling silver
AMBLER SURGICAL CORP.
Probe with eye
In Commercial Distribution

  • 00190660127718 ()
44-635

  • Fistula probe

Ambler Surgical - 00190660127701

Probe with eye, 4 1/2'', malleable, stainless steel
AMBLER SURGICAL CORP.
Probe with eye
In Commercial Distribution

  • 00190660127701 ()
44-625

  • Fistula probe

Ambler Surgical - 00190660127695

Probe with eye, 12'', malleable, sterling silver
AMBLER SURGICAL CORP.
Probe with eye
In Commercial Distribution

  • 00190660127695 ()
44-643

  • Fistula probe

ENDOVIS B.A. - 08032909620548

No Description
CITIEFFE SRL
Cannula with handle
In Commercial Distribution

  • 08032909620548 ()
EBA-0155

  • Surgical drill guide, reusable

ESTREMO - 08052990979608

No Description
CITIEFFE SRL
Obturator with handle
In Commercial Distribution

  • 08052990979608 ()
DT030090

  • Surgical drill guide obturator

ESTREMO - 08052990976300

No Description
CITIEFFE SRL
Cannula with handle
In Commercial Distribution

  • 08052990976300 ()
DT030022

  • Surgical drill guide, reusable

symphonX™ - 08719324463096

The symphonX™ Handle with ratchet is for use in combination with the symphonX™ Instruments of the types: Grasper (short), Maryland (short), Scissors (short) and Clip Applier (short).
Fortimedix Surgical B.V.
Handle with ratchet
Not in Commercial Distribution

  • 08719324463096 ()
314-302

  • Surgical instrument handle, non-torque-limiting

Restylane - 03770034301059

No Description
UNIVERDERM
Defyne with Lidocaine
In Commercial Distribution

  • 03770034301059 ()


  • Dermal tissue reconstructive material, microbe-derived, anaesthetic

Restylane - 03770034301042

No Description
UNIVERDERM
Kysse with Lidocaine
In Commercial Distribution

  • 03770034301042 ()


  • Dermal tissue reconstructive material, microbe-derived, anaesthetic

Restylane - 03770034301028

No Description
UNIVERDERM
Refyne with Lidocaine
In Commercial Distribution

  • 03770034301028 ()


  • Dermal tissue reconstructive material, microbe-derived, anaesthetic

Little Sucker® and Cover - 10812594011389

The Little Sucker/ NeoSucker are indicated to be used as a tip for suction tubing to aspirate fluids from the mouth and nares. The Little Sucker Cover is indicated for use to protect the Little Sucker Device. The Suction Caddy is intended to hold and store a suction device.
Neotech Products LLC
Standard with Cover
In Commercial Distribution

  • 10812594011389 ()
  • 00812594011382 ()
N205C

  • Airway suction catheter

Venous Line Clamp - 04033817900498

No Description
LivaNova Deutschland GmbH
with Remote Control
In Commercial Distribution

  • 04033817900498 ()


  • Cardiopulmonary bypass system, roller type

SafeRT-ID - 05056190500382

No Description
VISION RT LIMITED
SafeRT-ID (with interlock)
Not in Commercial Distribution

  • 05056190500382 ()


  • Patient-administration information system application software

CONTACT PLATE DELTA 20T - 04053755181315

No Description
Heine Optotechnik GmbH & Co. KG
STANDARD WITH SCALE
In Commercial Distribution

  • 04053755181315 ()
K-000.34.216

  • Dermatoscope, optical

CONTACT PLATE MINI3000 - 04053755124039

No Description
Heine Optotechnik GmbH & Co. KG
STANDARD WITH SCALE
In Commercial Distribution

  • 04053755124039 ()
D-000.78.117

  • Dermatoscope, optical

Infusion Pole - 07640143932450

No Description
Schaerer Medical AG
with fixing clamp
In Commercial Distribution

  • 07640143932450 ()
90500

  • Freestanding/bed-attached intravenous pole

Radial setting clamp - 07640143930906

rotating
Schaerer Medical AG
with fixing screw
In Commercial Distribution

  • 07640143930906 ()
90506

  • Medical table clamp
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