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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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REPLICaRE ULTRa 10X10CM CTN 10 - 05000223437732

Hydrocolloid wound dressing
SMITH & NEPHEW MEDICAL LIMITED
66000434
In Commercial Distribution

  • 05000223437770 ()
  • 05000223437732 ()
  • 05000223437817 ()
66000434

  • Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial

OPSITE 28X10CM US CTN 10 - 05000223415396

Incise surgical drape
SMITH & NEPHEW MEDICAL LIMITED
4542
In Commercial Distribution

  • 05000223403799 ()
  • 05000223415396 ()
  • 05000223045425 ()
4542

  • Patient surgical drape, single-use

Nephros EndoPur Endotoxin 10” Filter - 00866318000381

Intended Use: The Nephros EndoPur Endotoxin 10” Filter is a hollow fiber ultrafilter that retains bacteria and endotoxin from fluid. Indications for Use: The EndoPur Endotoxin 10” Filter Flat is intended to be used to filter water used in hemodialysis devices. It assists in providing hemodialysis quality water. The device is not a complete water treatment system, but serves to remove biological contaminants. Therefore it must be used in conjunction with other water treatment equipment (Reverse Osmosis, Deionization, etc.).
NEPHROS, INC.
70-0110H
In Commercial Distribution

  • 10866318000388 ()
  • 00866318000381 ()
  • 20866318000385 ()


  • Microbial water purification filter, non-sterilizable

EndoPur Endotoxin 10" Filter Fin - 00866318000367

Intended Use: The EndoPur Endotoxin 10” Filter Fin is a hollow fiber ultrafilter that retains bacteria and endotoxin from fluid. Indications for Use: The EndoPur Endotoxin 10” Filter Fin is intended to be used to filter water used in hemodialysis devices. It assists in providing hemodialysis quality water. The device is not a complete water treatment system, but serves to remove biological contaminants. Therefore it must be used in conjunction with other water treatment equipment (Reverse Osmosis, Deionization, etc.).
NEPHROS, INC.
70-0110F
Not in Commercial Distribution

  • 20866318000361 ()
  • 10866318000364 ()
  • 00866318000367 ()


  • Microbial water purification filter, non-sterilizable

Contoured Carving Block Style 10 - M724CCB1031

Contoured Carving Block Style 10
IMPLANTECH ASSOCIATES, INC.
Size 3
In Commercial Distribution

  • M724CCB1031 ()
CCB10-3

  • Silicone-block tissue reconstructive material

Contoured Carving Block Style 10 - M724CCB1021

Contoured Carving Block Style 10
IMPLANTECH ASSOCIATES, INC.
Size 2
In Commercial Distribution

  • M724CCB1021 ()
CCB10-2

  • Silicone-block tissue reconstructive material

Contoured Carving Block Style 10 - M724CCB1011

Contoured Carving Block Style 10
IMPLANTECH ASSOCIATES, INC.
Size 1
In Commercial Distribution

  • M724CCB1011 ()
CCB10-1

  • Silicone-block tissue reconstructive material

DISPOSABLE NITINOL NEEDLE 10 PACK - 00880304677036

No Description
Biomet Orthopedics, LLC
110010852
In Commercial Distribution

  • 00880304677036 ()
110010852

  • Suturing unit, single-use

KMC Drill, 10 Gauge, 200mm - 06938695546364

KMC Drill, 10 Gauge, 200mm
Shanghai Kinetic Medical Co., Ltd.
KMC-012-00
In Commercial Distribution

  • 06938695546364 ()

  • Needle Gauge: 10 Gauge
  • Length: 200 Millimeter


  • Bone access channel kit

KMC Working Channel, 10 Gauge - 06938695546289

KMC Working Channel, 10 Gauge
Shanghai Kinetic Medical Co., Ltd.
KMC-008-01
In Commercial Distribution

  • 06938695546289 ()

  • Needle Gauge: 10 Gauge


  • Bone access channel kit
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