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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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Nylon Monofilament Non-absorbable Suture 30 inch in length, USP 6/0, Reverse Cutting Needle, 16mm, 3/8 curvature, Sterile
Golnit Sutures
NB2D6016-75
In Commercial Distribution

  • 00850043243113 ()
  • 00850043243083 ()

  • Length: 30 Inch
  • USP 6/0 Suture Thread
  • 16mm 3/8 Circle Reverse Cutting Needle


  • Polyolefin/fluoropolymer suture, monofilament
Nylon Monofilament Non-absorbable Suture 30 inch in length, USP 3/0, Reverse Cutting Needle, 19mm, 3/8 curvature, Sterile
Golnit Sutures
NB2D3019-75
In Commercial Distribution

  • 00850043243045 ()
  • 00850043243038 ()

  • Length: 30 Inch
  • USP 3/0 Suture Thread
  • 19mm 3/8 Circle Reverse Cutting Needle


  • Polyolefin/fluoropolymer suture, monofilament
Nylon Monofilament Non-absorbable Suture 30 inch in length, USP 4/0, Reverse Cutting Needle, 18mm, 3/8 curvature, Sterile
Golnit Sutures
NB2D4018-75
In Commercial Distribution

  • 00850043243052 ()
  • 00850043243021 ()

  • Length: 30 Inch
  • USP 4/0 Suture Thread
  • 18mm 3/8 Circle Reverse Cutting Needle


  • Polyolefin/fluoropolymer suture, monofilament
Nylon Monofilament Non-absorbable Suture 30 inch in length, USP 4/0, Reverse Cutting Needle, 16mm, 3/8 curvature, Sterile
Golnit Sutures
NB2D4016-75
In Commercial Distribution

  • 00850043243069 ()
  • 00850043243014 ()

  • Length: 30 Inch
  • USP 4/0 Suture Thread
  • 16mm 3/8 Circle Reverse Cutting Needle


  • Polyolefin/fluoropolymer suture, monofilament
Nylon Monofilament Non-absorbable Suture 30 inch in length, USP 5/0, Reverse Cutting Needle, 16mm, 3/8 curvature, Sterile
Golnit Sutures
NB2D5016-75
In Commercial Distribution

  • 00850043243076 ()
  • 00850043243007 ()

  • Length: 30 Inch
  • USP 5/0 Suture Thread
  • 16mm 3/8 Circle Reverse Cutting Needle


  • Polyolefin/fluoropolymer suture, monofilament
PuraStat Gel is a hemostat for mild and moderate bleeding intended to be used in gastrointestinal surgery (1 mL).
3-D MATRIX INC.
621-061
In Commercial Distribution

  • 00860001820867 ()
621-061

  • Non-organic haemostatic agent
Single infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use.
Unomedical A/S
MMT-377A
In Commercial Distribution

  • 05705244019515 ()
  • 05705244019508 ()
  • 05705244019522 ()

  • Length: 110 Centimeter
  • Depth: 17 Millimeter
  • Angle: 30 degree


  • Electric infusion pump administration set, single-use
Cannula for Knee is intended to be used to deliver bone cement in the knee through Tecres' Cemex System.
TECRES SPA
ASA0010
In Commercial Distribution

  • 08031497002217 ()


  • Orthopaedic cement injection cannula
PCRopsis™ Reagent RVD with RVD Enhancer mediates extraction-free RT-qPCR of swab specimens transported in compatible universal transport medium.
ENTOPSIS, LLC
Reagent RVD
Not in Commercial Distribution

  • B55078310000 ()
7831000

  • Nucleic acid extraction/isolation kit IVD
PCRopsis™ Reagent RVD with RVD Enhancer mediates extraction-free RT-qPCR of swab specimens transported in compatible universal transport medium.
ENTOPSIS, LLC
Reagent RVD
Not in Commercial Distribution

  • B5507831000 ()
783100

  • Nucleic acid extraction/isolation kit IVD
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