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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Unistik 3 Extra - 21G x 2.0mm, sterile, single use safety lancet
OWEN MUMFORD LIMITED
AT 1012
In Commercial Distribution

  • 00384701012037 ()
  • 00384701012013 ()
  • 00384701012006 ()

  • Depth: 2.0 Millimeter
  • Needle Gauge: 21 Gauge


  • Manual blood lancing device, single-use
Unistik 3 Normal 23G x 1.8mm, 25 count - sterile, single use safety lancet
OWEN MUMFORD LIMITED
AT 1008
In Commercial Distribution

  • 00384701008030 ()
  • 00384701008016 ()
  • 00384701002007 ()

  • Depth: 1.8 Millimeter
  • Needle Gauge: 23 Gauge


  • Manual blood lancing device, single-use
Unistik 3 Normal - 23G x 1.8mm, 50 count - sterile, single use safety lancet
OWEN MUMFORD LIMITED
AT 1007
In Commercial Distribution

  • 00384701007033 ()
  • 00384701007026 ()
  • 00384701007019 ()
  • 00384701002007 ()

  • Depth: 1.8 Millimeter
  • Needle Gauge: 23 Gauge


  • Manual blood lancing device, single-use
Unistik 3 Normal - 23G x 1.8mm, 200 count - sterile, single use safety lancet
OWEN MUMFORD LIMITED
AT 1004
In Commercial Distribution

  • 00384701004032 ()
  • 00384701004018 ()
  • 00384701002007 ()

  • Depth: 1.8 Millimeter
  • Needle Gauge: 23 Gauge


  • Manual blood lancing device, single-use
Unistik 3 Normal 23G x 1.8mm, 1000 count - sterile, single use safety lancet
OWEN MUMFORD LIMITED
AT 1003
In Commercial Distribution

  • 00384701003011 ()
  • 00384701002007 ()

  • Depth: 1.8 Millimeter
  • Needle Gauge: 23 Gauge


  • Manual blood lancing device, single-use
Unistik 3 Normal - 23G x 1.8mm - sterile, single use safety lancet
OWEN MUMFORD LIMITED
AT 1002
In Commercial Distribution

  • 00384701002038 ()
  • 00384701002014 ()
  • 00384701002007 ()

  • Depth: 1.8 Millimeter
  • Needle Gauge: 23 Gauge


  • Manual blood lancing device, single-use
Unilet ComforTouch 28G Ultra Thin Lancets 100 count
OWEN MUMFORD USA INCORPORATED
AT 0925
In Commercial Distribution

  • 00384700925031 ()
  • 00384700925017 ()
  • 00384700925000 ()

  • Needle Gauge: 28 Gauge


  • Blood lancing device tip
Sterile, single use safety lancet
OWEN MUMFORD LIMITED
AT 0752
In Commercial Distribution

  • 00384700752033 ()
  • 00384700752019 ()
  • 00384700752002 ()

  • Depth: 3.0 Millimeter
  • Needle Gauge: 18 Gauge


  • Manual blood lancing device, single-use
Unistik Comfort, 28G x 1.8mm - sterile, single use safety lancet
OWEN MUMFORD LIMITED
AT 0747
In Commercial Distribution

  • 00384700747039 ()
  • 00384700747015 ()
  • 00384700742003 ()

  • Needle Gauge: 28 Gauge
  • Depth: 1.8 Millimeter


  • Manual blood lancing device, single-use
Unistik Extra, 21G x 2.0mm, 200 count - sterile, single use safety lancet
OWEN MUMFORD LIMITED
AT 0714
In Commercial Distribution

  • 00384700714031 ()
  • 00384700714017 ()
  • 00384700712006 ()

  • Needle Gauge: 21 Gauge
  • Depth: 2.0 Millimeter


  • Manual blood lancing device, single-use
Unistik Extra, 21G x 2.0mm - sterile, single use safety lancets
OWEN MUMFORD LIMITED
AT 0712
In Commercial Distribution

  • 00384700712037 ()
  • 00384700712013 ()
  • 00384700712006 ()

  • Needle Gauge: 21 Gauge
  • Depth: 2.0 Millimeter


  • Manual blood lancing device, single-use
Unistik Normal, 23G x 1.8mm, 200 count - sterile, single use safety lancet
OWEN MUMFORD LIMITED
AT 0704
In Commercial Distribution

  • 00384700704032 ()
  • 00384700704018 ()
  • 00384700702007 ()

  • Needle Gauge: 23 Gauge
  • Depth: 1.8 Millimeter


  • Manual blood lancing device, single-use
Unistik Normal, 23G x 1.8mm - sterile single use safety lancet
OWEN MUMFORD LIMITED
AT 0702
In Commercial Distribution

  • 00384700702038 ()
  • 00384700702014 ()
  • 00384700702007 ()

  • Needle Gauge: 23 Gauge
  • Depth: 1.8 Millimeter


  • Manual blood lancing device, single-use
Unilet Micro Thin 33G Lancets 100 count
OWEN MUMFORD USA INCORPORATED
AT 0585
In Commercial Distribution

  • 00384700585037 ()
  • 00384700585013 ()
  • 00384700585006 ()

  • Needle Gauge: 33 Gauge


  • Blood lancing device tip
Unilet 30G Super Thin Lancets 100 count
OWEN MUMFORD USA INCORPORATED
AT 0575
In Commercial Distribution

  • 00384700575038 ()
  • 00384700575014 ()
  • 00384700575007 ()

  • Needle Gauge: 30 Gauge


  • Blood lancing device tip
Unilet 28G Ultra Thin Lancets 100 count
OWEN MUMFORD USA INCORPORATED
AT 0565
In Commercial Distribution

  • 00384700565039 ()
  • 00384700565015 ()
  • 00384700565008 ()

  • Needle Gauge: 28 Gauge


  • Blood lancing device tip
Unilet ComforTouch 30G Super Thin Lancets 100 count
OWEN MUMFORD USA INCORPORATED
AT 0465
In Commercial Distribution

  • 00384700465032 ()
  • 00384700465018 ()
  • 00384700465001 ()

  • Needle Gauge: 30 Gauge


  • Blood lancing device tip
Unilet ComforTouch Thin Lancets 23G 100 count
OWEN MUMFORD USA INCORPORATED
AT 0455
In Commercial Distribution

  • 00384700455033 ()
  • 00384700455019 ()
  • 00384700455002 ()

  • Needle Gauge: 23 Gauge


  • Blood lancing device tip
Autolet Lancing Device with 10 30G lancets in a bag
OWEN MUMFORD USA INCORPORATED
AT 0272
In Commercial Distribution

  • 00384700272012 ()


  • Manual blood lancing device, reusable
Autolet Lancing Device
OWEN MUMFORD USA INCORPORATED
AT 0271
In Commercial Distribution

  • 00384700271039 ()
  • 00384700271015 ()


  • Manual blood lancing device, reusable
Autolet Lancing Device
OWEN MUMFORD USA INCORPORATED
AT 0270
In Commercial Distribution

  • 00384700270025 ()
  • 00384700270018 ()
  • 00384700270032 ()


  • Manual blood lancing device, reusable
880VS series medical suction kit (aka suction kit) is a continuous suction kit powered from pressure gas. This is a long term, non-invasive, active medical device. It can be used to medical suction for tracheal suction, pharyngeal aspiration, gastro-intestinal drainage, and surgical suction.
GENTEC(SHANGHAI)CORPORATION
880VS-760-CH/A-T
In Commercial Distribution

  • 06970966663134 ()


  • General-purpose surgical suction system, pneumatic
1st Tier Unilet Lancets 33G
OWEN MUMFORD USA INCORPORATED
AT 0585FT
In Commercial Distribution

  • 00761059585008 ()
  • 00761059585367 ()

  • Needle Gauge: 33 Gauge


  • Blood lancing device tip
1st Tier Unilet lancets 28G
OWEN MUMFORD USA INCORPORATED
AT 0565FT
In Commercial Distribution

  • 00761059565000 ()
  • 00761059565369 ()

  • Needle Gauge: 28 Gauge


  • Blood lancing device tip
1st Tier Unilet Comfortouch Lancets 28G
OWEN MUMFORD USA INCORPORATED
AT 0925FT
In Commercial Distribution

  • 00761059257004 ()
  • 00761059257363 ()

  • Needle Gauge: 28 Gauge


  • Blood lancing device tip
1st Tier Unilet Comfortouch 30G
OWEN MUMFORD USA INCORPORATED
AT 0465FT
In Commercial Distribution

  • 00761059657002 ()
  • 00761059657361 ()

  • Needle Gauge: 30 Gauge


  • Blood lancing device tip
1st Tier Unilet Lancets 30G
OWEN MUMFORD USA INCORPORATED
AT 0575FT
In Commercial Distribution

  • 00761059575009 ()
  • 00761059575368 ()

  • Needle Gauge: 30 Gauge


  • Blood lancing device tip
Scanbody retention screw
MEDENTiKA GmbH
AT 60 SB
In Commercial Distribution

  • 04251574860255 ()
AT 60 SB

  • Dental implant abutment analog, intraoral-scanning, single-use
Placement instrument laboratory implant
MEDENTiKA GmbH
AT 81 T-ET
In Commercial Distribution

  • 04251574860071 ()
AT 81 T-ET

  • Manual non-rotary dental instrument handle
Placement instrument laboratory implant
MEDENTiKA GmbH
AT 81 T
In Commercial Distribution

  • 04251574860064 ()
AT 81 T

  • Manual non-rotary dental instrument handle
Placement instrument laboratory implant
MEDENTiKA GmbH
AT 80 T-ET
In Commercial Distribution

  • 04251574860033 ()
AT 80 T-ET

  • Manual non-rotary dental instrument handle
Placement instrument laboratory implant
MEDENTiKA GmbH
AT 80 T
In Commercial Distribution

  • 04251574860026 ()
AT 80 T

  • Manual non-rotary dental instrument handle
Laboratory screw
MEDENTiKA GmbH
AT 60 L
In Commercial Distribution

  • 04251574859822 ()
AT 60 L

  • Dental implant suprastructure, permanent, preformed
Assembled, tray packed, and sterilized at Oscor Caribe, then final packaged at Oscor, Inc.
MAINSTAY MEDICAL LIMITED
7M8145-006
Not in Commercial Distribution

  • 05391527772071 ()
8145

  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection
OPTIVISOR MAGNIFIER #DA-3
SONTEC INSTRUMENTS, INC.
1103-402
In Commercial Distribution

  • 00192896096226 ()

  • 1.75 Magnification at 14 Inches
1103-402

  • Spectacle-mounted magnifier
OPTIVISOR BINOCULAR MAGNIFIER #DA-7
SONTEC INSTRUMENTS, INC.
1103-4001
In Commercial Distribution

  • 00192896053144 ()

  • 2.7 Maginification at 8 Inches
1103-4001

  • Surgical binoculars, reusable
OPTIVISOR BINOCULAR MAGNIFIER #DA-5
SONTEC INSTRUMENTS, INC.
1103-400
In Commercial Distribution

  • 00192896053137 ()

  • 2.5 Magnification at 8 Inches
1103-400

  • Surgical binoculars, reusable
No Description
LUMENIS LTD.
OtoLase™ Curved HP
In Commercial Distribution

  • 07290109142814 ()

  • curved at angle 15 degrees
  • Length: 108 Millimeter
AC-2003613

  • General/multiple surgical laser system beam guide, reusable
Surgical Gown, Level 4, knit v-neck, ties at waist, grips at neck, patented Size 3XL
Lac-Mac Limited
005XH-3XL
In Commercial Distribution

  • 00627755057150 ()

  • Height: 54.5 Inch
  • Width: 33.5 Inch
005XH-3XL

  • Surgical gown, reusable
Surgical Gown, Level 4, knit v-neck, ties at waist, grips at neck, patented Size 2XL
Lac-Mac Limited
005XFAN-2XL
In Commercial Distribution

  • 00627755056979 ()

  • Height: 57.25 Inch
005XFAN-2XL

  • Surgical gown, reusable
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