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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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InPouch® TV - B08810310

Self-contained media system for the recovery and detection of T. vaginalis from female vaginal samples or male urethra/urine samples.
BIO-MED DIAGNOSTICS, INC.
1031
In Commercial Distribution

  • B08810310 ()
  • B08810317 ()
  • B08810313 ()
21-031-001

  • Differential/selective broth culture medium IVD

CosmoLock Pedicle Screw System - B07311LCL00000

Locking Cap
Kalitec Direct LLC
11-LCL-0000
In Commercial Distribution

  • B07311LCL00000 ()
  • B07311LCL00002 ()
  • B07311LCL00001 ()


  • Bone-screw internal spinal fixation system, non-sterile

CUVETTES DC-80 Box 100 cuvettes & 100 plugs - B154O00103910003

Box containing 100 cuvettes and 100 cuvette plugs for use with Oxicom oximeter.
WATERS MEDICAL SYSTEMS, LLC
Cuvette/Plug Kit
In Commercial Distribution

  • B154O00103910003 ()
  • 0034791000 ()
  • 0033991000 ()
0010391.000

  • Intracardiac oximeter

Q-Lase™ Adjustable Sheath - B145115150

Q-Lase Adjustable Sheath
OPTICAL INTEGRITY INC
11515
In Commercial Distribution

  • B145115152 ()
  • B145115151 ()
  • B145115150 ()

  • Outer Diameter: 800 Micrometer
  • fiber core diameter


  • General/multiple surgical laser system beam guide, reusable

Molded Products, Inc. - B144UM872360

STERILE ACCESS & RETURN LINE SET
MOLDED PRODUCTS, INC.
UM-872-36
In Commercial Distribution

  • B144UM872360 ()
  • B144UM872361 ()
  • B144UM872364 ()
UM-872-36

  • Haemodialysis blood tubing set, single-use

Molded Products, Inc. - B144MPC8750

Sterile DIN to Male DIN Connector
MOLDED PRODUCTS, INC.
MPC-875
In Commercial Distribution

  • B144MPC8753 ()
  • B144MPC8751 ()
  • B144MPC8750 ()
MPC-875

  • Haemodialysis blood tubing set, single-use

Molded Products, Inc. - B144MPC8700

Sterile Bloodline Extension
MOLDED PRODUCTS, INC.
MPC-870
In Commercial Distribution

  • B144MPC8703 ()
  • B144MPC8701 ()
  • B144MPC8700 ()
MPC-870

  • Haemodialysis blood tubing set, single-use

Molded Products, Inc. - B144MPC8650

Sterile Female Luer to Male DIN Connector
MOLDED PRODUCTS, INC.
MPC-865
In Commercial Distribution

  • B144MPC8651 ()
  • B144MPC8650 ()
  • B144MPC8653 ()
MPC-865

  • Haemodialysis blood tubing set, single-use

Molded Products, Inc. - B144MPC855S250PP3

Sterile DIN Adapter, Polypropylene, Fits 1/4" ID Tubing
MOLDED PRODUCTS, INC.
MPC-855S.250PP
In Commercial Distribution

  • B144MPC855S250PP5 ()
  • B144MPC855S250PP4 ()
  • B144MPC855S250PP3 ()
  • B144MPC855NS250PP0 ()
MPC-855S.250PP

  • Haemodialysis blood tubing set, single-use

Molded Products, Inc. - B144MPC8550

Sterile DIN Adapter Set
MOLDED PRODUCTS, INC.
MPC-855
In Commercial Distribution

  • B144MPC8551 ()
  • B144MPC8550 ()
  • B144MPC8552 ()
MPC-855

  • Haemodialysis blood tubing set, single-use
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