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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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RenovaRP - 00893029002168

The RenovaRP® Tube Set is intended for use in conjunction with the RenovaRP Centesis Pump and the RenovaRP Fluid Drainage Bags to remove ascitic fluid from the abdominal cavity for paracentesis, and remove pleural effusion from the thoracic cavity for thoracentesis. The RenovaRP Tube Set is intended to be used by medically trained healthcare professionals knowledgeable about paracentesis and thoracentesis.
GI Supply, Inc.
GIS-30
In Commercial Distribution

  • 10893029002165 ()
  • 00893029002168 ()
GIS-30

  • Pleurocentesis/paracentesis kit

RenovaRP - 00893029002236

The Laborie RenovaRP® Centesis Kit is intended to be used in conjunction with the RenovaRP Pump, the RenovaRP Tube Set and the RenovaRP Fluid Drainage Bags to remove ascitic fluid from the abdominal cavity for paracentesis, and remove pleural effusion from the thoracic cavity for thoracentesis. The RenovaRP Centesis Kit is intended to be used by medically trained healthcare professionals knowledgeable about paracentesis and thoracentesis.
GI Supply, Inc.
GIS-31
In Commercial Distribution

  • 10893029002233 ()
  • 00893029002236 ()
GIS-31

  • Pleurocentesis/paracentesis kit

RenovaRP - 00893029002175

The Laborie RenovaRP® Centesis Kit is intended to be used in conjunction with the RenovaRP Pump, the RenovaRP Tube Set and the RenovaRP Fluid Drainage Bags to remove ascitic fluid from the abdominal cavity for paracentesis, and remove pleural effusion from the thoracic cavity for thoracentesis. The RenovaRP Centesis Kit is intended to be used by medically trained healthcare professionals knowledgeable about paracentesis and thoracentesis.
GI Supply, Inc.
GIS-32
In Commercial Distribution

  • 00893029002175 ()
  • 10893029002172 ()
GIS-32

  • Pleurocentesis/paracentesis kit

EPIONE RoboKit Plus - 03760305400253

The EPIONE® RoboKit™ Plus is used during the CT guided procedures performed with EPIONE®. Sterile drapes are used to cover: the robotic arm, the touchscreen of the display cart, the tray of the display cart supporting the mouse and the keyboard. Reflective spheres to be placed on the tracked EPIONE instruments tracked. The EPIONE® RoboKit™ Plus includes the accessories individually packaged in their primary packaging considered as sterile, but the EPIONE® RoboKit™ Plus is not sterile.
QUANTUM SURGICAL
09-0046
In Commercial Distribution

  • 03760305400253 ()


  • Surgical optical-tracking spatial marker, single-use

EPIONE RoboKit - 03760305400260

The EPIONE® RoboKit™ is used during the CT guided procedures performed with EPIONE®. Sterile drapes are used to cover: the robotic arm, the touchscreen of the display cart, the tray of the display cart supporting the mouse and the keyboard. Reflective spheres to be placed on the tracked EPIONE instruments tracked.
QUANTUM SURGICAL
09-0057
In Commercial Distribution

  • 03760305400260 ()


  • Surgical optical-tracking spatial marker, single-use

RED Prep-Kit - B960RED202

The Rectal Expulsion Device Prep-kit (RED Prep-kit, PN 02-2051) consists of five (5) cartons and is to be used with the NeurAxis RED (PN 02-2050, UDI: B960RED201) device. Each of the five cartons contains the following items: 1) One (1) pack of Extra-Large Heavy Absorbency Disposable Under-pads. Medline, MSC282070LB or similar. Product Code LRO. 2) Two (2) tubes of single use Lubricating Jelly. Medline, MDS032280 or similar. Product Code KMJ. 3) Two (2) packs of 10/hard tray Woven Sterile Gauze Sponges 4"x4", 12-ply. Medline, NON21426 or similar. Product Code EFQ. 4) One (1) pack of five (5) Ready Bath Select Bathing cloths 8x8 inch. Medline, MSC095109 or similar. Product Code KKX. 5) One (1) Sterile Skin Marker with Ruler. Medline, DYNJSM01 or similar. Product Code FTY. 6) One Instructions For Use [IFU] (LBL6014). Minimum 1 IFU/Box.
Neuraxis, Inc.
02 2051 RED
In Commercial Distribution

  • B960RED202 ()
  • B960RED2020 ()
  • B960RED2021 ()
  • B960RED2022 ()
  • B960RED2023 ()
  • B960RED2024 ()
  • B960RED2025 ()
02-2051

  • General surgical procedure kit, non-medicated, single-use

SURGICAL PROCEDURE PACK - 08056646500222

Indication For Use: Surgical Procedure Packs is a kit for oral implantology, used by dental professionals when performing surgical procedures. Surgical Procedure Packs are composed of disposable devices intended for professional use in preparing the operating environment with protective coverings and clothes that aid in maintaining cleanliness and limiting risk of contamination during various types of medical and/or dental surgeries. Surgical Procedure Packs may be packages as a combination of any of the following components: - Surgical gowns (various models) with or without hand towels - Surgical Drapes: - Mayo drape - Absorbent/liquid proof drapes (with or without adhesive) - Adhesive side drape - Liquid repellent drape with or without adhesive - Face mask - Protective caps - Sheath/tubing sleeve - Surgical aspirator with adaptor - Surgical gauze - Disinfection sponge and/or basin - Adhesive films - Syringe - Needles - Single-use scalpel - Small dental mirror/dental explorer/tweezer - Irrigation/infusion line - Stopcock and ramp for infusion - Waste bag for contaminated material - Bone collector - Saliva ejector - Basin - Medical paper Possible combination of any of the devices mentioned are identified with different UDI code listed in the section "Package DI" Model Number: X = alphabetic character YYYY= n° of 4 number character
OMNIA SRL
12.XYYYY.00
In Commercial Distribution

  • 8056646500239 ()
  • 08056646500222 ()
  • 8056646500246 ()
  • 8056646500352 ()
  • 8056646500253 ()
  • 8056646500260 ()
  • 8056646500277 ()
  • 8056646500284 ()
  • 8056646500291 ()
  • 8056646500307 ()
  • 8056646500314 ()
  • 8056646500321 ()
  • 8056646500338 ()
  • 8056646500345 ()
  • 8056646500437 ()
  • 8056646500420 ()
  • 8056646500413 ()
  • 8056646500406 ()
  • 8056646500390 ()
  • 8056646500383 ()
  • 8056646500376 ()
  • 8056646500369 ()
  • 8056646500451 ()
  • 8056646500444 ()
  • 8056646500475 ()
  • 8056646500468 ()
  • 80566465000505 ()
  • 805664650505 ()
  • 8056646500505 ()
  • 8056646500512 ()
  • 08056646500529 ()
  • 08056646500536 ()
  • 08056646500543 ()
  • 08056646500550 ()
  • 08056646500567 ()
  • 08056646500581 ()
  • 08056646500635 ()
  • 08056646500628 ()
  • 08056646500611 ()
  • 08056646500574 ()
  • 08056646500604 ()
  • 08056646500598 ()
  • 08056646500659 ()
  • 08056646500666 ()
  • 08056646500642 ()
  • 08056646500673 ()
  • 08056646500680 ()
  • 08056646500697 ()
  • 08056646500826 ()
  • 08056646500819 ()
  • 08056646500802 ()
  • 08056646500796 ()
  • 08056646500789 ()
  • 08056646500772 ()
  • 08056646500765 ()
  • 08056646500758 ()
  • 08056646500734 ()
  • 08056646500727 ()
  • 08056646500710 ()
  • 08056646500703 ()


  • General surgical procedure kit, non-medicated, single-use

Bioseal Inc. - 00630094198033

Alkaline Battery
BIOSEAL
19803/50
In Commercial Distribution

  • 10630094198030 ()
  • 00630094198033 ()


  • Disposable battery pack

Henry Schein - 10304040118686

Extremity Procedure Pack
HENRY SCHEIN, INC.
5701576
In Commercial Distribution

  • 10304040118686 ()
5701576

  • General-purpose syringe, single-use

Henry Schein - 10304040118679

Knee Arthroscopy Plus Procedur
HENRY SCHEIN, INC.
5701577
In Commercial Distribution

  • 10304040118679 ()
5701577

  • General-purpose syringe, single-use
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