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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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Procedure pack for Novilase Laser Therapy System containing single-use disposables for laser ablation procedure. Pack contains sterile kit with (1) 150 mm laser probe with removable stylet and 1 temperature sensor, (1) 150 mm thermal probe with 5 temperature sensors, (1) optical fiber, and (1) probe guide; and (1) 30 ml sterile syringe. For distribution in Switzerland.
Novian Health Inc.
Switzerland: 150 mm
In Commercial Distribution

  • 00860011448006 ()
100011-03

  • General/multiple surgical laser system beam guide, single-use
The Tissue Approximation System (TAS) consists of a polyamide (nylon) “zip-tie” attached to a braided polyethylene terephthalate (PET, or Dacron) leader to aid insertion. A one-way clasp allows for fixation of the tissue approximation without the need to tie surgical knots. When packaged for commercial distribution, four zip-ties with integrated suture leaders are accompanied by hand-held instruments that can be optionally used for insertion. The kit will be provided sterile within a polyethylene/Tyvek pouch.
TAS Medical, Inc.
T-5000
In Commercial Distribution

  • 00860011435921 ()

  • Length: 37 Centimeter
  • Width: 2.7 Millimeter
  • Height: 1.4 Millimeter
T-5000

  • Nylon suture, non-bioabsorbable, monofilament
The Tissue Approximation System (TAS) consists of a polyamide (nylon) “zip-tie” attached to a braided polyethylene terephthalate (PET, or Dacron) leader to aid insertion. A one-way clasp allows for fixation of the tissue approximation without the need to tie surgical knots. When packaged for commercial distribution, four zip-ties with integrated suture leaders are accompanied by hand-held instruments that can be optionally used for insertion. The kit will be provided sterile within a polyethylene/Tyvek pouch.
TAS Medical, Inc.
T-LAP
In Commercial Distribution


  • Length: 37 Centimeter
  • Width: 2.7 Millimeter
  • Height: 1.4 Micrometer
T-LAP

  • Nylon suture, non-bioabsorbable, monofilament
The Tissue Approximation System (TAS) consists of a polyamide (nylon) “zip-tie” attached to a braided polyethylene terephthalate (PET, or Dacron) leader to aid insertion. A one-way clasp allows for fixation of the tissue approximation without the need to tie surgical knots. When packaged for commercial distribution, four zip-ties with integrated suture leaders are accompanied by hand-held instruments that can be optionally used for insertion. The kit will be provided sterile within a polyethylene/Tyvek pouch.
TAS Medical, Inc.
T-4000
In Commercial Distribution


  • Length: 37 Centimeter
  • Width: 2.7 Millimeter
  • Height: 1.4 Micrometer
T-4000

  • Nylon suture, non-bioabsorbable, monofilament
No Description
Quick Tube Medical, LLC
CTD-16
In Commercial Distribution

  • 10860011294709 ()
  • 00860011294702 ()


  • Pleural catheter
Packaged Ziplyft Blepharoplasty Kit (Gen2)
Osheru, L.L.C.
90-OSH-000001
In Commercial Distribution

  • 00860011170693 ()
  • 00860013297909 ()


  • Ophthalmic knife, single-use
EpiZact is a single use medical device used during an epidural procedure.
GuideStar Medical Devices Inc
GMD1-001
In Commercial Distribution

  • 00860011139607 ()
  • 00860011139614 ()


  • Low-resistance epidural syringe
Veloxion Fluid Control Set
Aulea Medical Inc.
1327
In Commercial Distribution

  • 00860011104414 ()
1327

  • Resectoscope
Veloxion Resectoscope
Aulea Medical Inc.
2490
In Commercial Distribution

  • 00860011104407 ()
2490

  • Resectoscope
Pin Site Sponge
Os Medica, LLC
950S
In Commercial Distribution

  • 00860011062608 ()
  • 00860011062615 ()
  • 50860011062603 ()
950S

  • Wound-nonadherent dressing, absorbent, non-antimicrobial
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