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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POTTS SMITH Vascular Scissor, Angled at 45, 19cm
DR.FRIGZ INTERNATIONAL(PVT)LTD,
POTTS SMITH Vascular Scissor
In Commercial Distribution

  • B974DF274250 ()

  • Length: 19 Centimeter
DF-27-425

  • General-purpose surgical scissors, single-use
2.7 Y Plate with 4-Hole at the Diaphysis
Neoortho Produtos Ortopédicos S/A.
900.982
In Commercial Distribution

  • 07899893204533 ()


  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
2.7 Y Plate with 3-Hole at the Diaphysis
Neoortho Produtos Ortopédicos S/A.
900.981
In Commercial Distribution

  • 07899893204526 ()


  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
2.7 T Plate with 4-Hole at the Diaphysis
Neoortho Produtos Ortopédicos S/A.
900.980
In Commercial Distribution

  • 07899893204519 ()


  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
2.7 T Plate with 3-Hole at the Diaphysis
Neoortho Produtos Ortopédicos S/A.
900.979
In Commercial Distribution

  • 07899893204502 ()


  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Anterior Spinal Curette #2 18" ANG at 30mm
Life Instrument Corporation
710-1802-0-1
In Commercial Distribution

  • M9307101802010 ()


  • Bone curette, reusable
3 HOLES LUMBOSACRAL PLATE Size 6 at 115°
MEDICREA INTERNATIONAL
B14032015
Not in Commercial Distribution

  • 03613720192961 ()


  • Spinal fixation plate, non-bioabsorbable
3 HOLES LUMBOSACRAL PLATE Size 5 at 130°
MEDICREA INTERNATIONAL
B14031830
Not in Commercial Distribution

  • 03613720192954 ()


  • Spinal fixation plate, non-bioabsorbable
3 HOLES LUMBOSACRAL PLATE Size 5 at 115°
MEDICREA INTERNATIONAL
B14031815
Not in Commercial Distribution

  • 03613720192947 ()


  • Spinal fixation plate, non-bioabsorbable
3 HOLES LUMBOSACRAL PLATE Size 4 at 130°
MEDICREA INTERNATIONAL
B14031630
Not in Commercial Distribution

  • 03613720192930 ()


  • Spinal fixation plate, non-bioabsorbable
3 HOLES LUMBOSACRAL PLATE Size 4 at 115°
MEDICREA INTERNATIONAL
B14031615
Not in Commercial Distribution

  • 03613720192923 ()


  • Spinal fixation plate, non-bioabsorbable
3 HOLES LUMBOSACRAL PLATE Size 3 at 130°
MEDICREA INTERNATIONAL
B14031430
Not in Commercial Distribution

  • 03613720192916 ()


  • Spinal fixation plate, non-bioabsorbable
3 HOLES LUMBOSACRAL PLATE Size 3 at 115°
MEDICREA INTERNATIONAL
B14031415
Not in Commercial Distribution

  • 03613720192909 ()


  • Spinal fixation plate, non-bioabsorbable
3 HOLES LUMBOSACRAL PLATE Size 2 at 130°
MEDICREA INTERNATIONAL
B14031230
Not in Commercial Distribution

  • 03613720192893 ()


  • Spinal fixation plate, non-bioabsorbable
3 HOLES LUMBOSACRAL PLATE Size 2 at 115°
MEDICREA INTERNATIONAL
B14031215
Not in Commercial Distribution

  • 03613720192886 ()


  • Spinal fixation plate, non-bioabsorbable
3 HOLES LUMBOSACRAL PLATE Size 1 at 130°
MEDICREA INTERNATIONAL
B14031030
Not in Commercial Distribution

  • 03613720192879 ()


  • Spinal fixation plate, non-bioabsorbable
AM/AT PI MDL 1-L: 4.5FR X 15CM
TELEFLEX INCORPORATED
IPN055404
In Commercial Distribution

  • 20801902156208 ()
  • 10801902156201 ()
ASK-41541-VAD1

  • Vascular catheter introduction set, nonimplantable
AM/AT PI MDL 1-L: 4.5FR X 15CM
TELEFLEX INCORPORATED
IPN914812
In Commercial Distribution

  • 20801902158158 ()
  • 10801902158151 ()
ASK-41541-SH1

  • Vascular catheter introduction set, nonimplantable
Optical Zone Marker, Quadrant Markings at 3,5,7 mm
RUMEX INTERNATIONAL CORP.
3-203
In Commercial Distribution

  • 00840159908600 ()
3-203

  • Corneal marker, reusable
4 HOLES LUMBOSACRAL PLATE Size 6 at 130°
MEDICREA INTERNATIONAL
B14012030
Not in Commercial Distribution

  • 03613720192855 ()


  • Spinal fixation plate, non-bioabsorbable
4 HOLES LUMBOSACRAL PLATE Size 6 at 115°
MEDICREA INTERNATIONAL
B14012015
Not in Commercial Distribution

  • 03613720192848 ()


  • Spinal fixation plate, non-bioabsorbable
4 HOLES LUMBOSACRAL PLATE Size 5 at 130°
MEDICREA INTERNATIONAL
B14011830
Not in Commercial Distribution

  • 03613720192831 ()


  • Spinal fixation plate, non-bioabsorbable
4 HOLES LUMBOSACRAL PLATE Size 5 at 115°
MEDICREA INTERNATIONAL
B14011815
Not in Commercial Distribution

  • 03613720192824 ()


  • Spinal fixation plate, non-bioabsorbable
4 HOLES LUMBOSACRAL PLATE Size 4 at 130°
MEDICREA INTERNATIONAL
B14011630
Not in Commercial Distribution

  • 03613720192817 ()


  • Spinal fixation plate, non-bioabsorbable
4 HOLES LUMBOSACRAL PLATE Size 4 at 115°
MEDICREA INTERNATIONAL
B14011615
Not in Commercial Distribution

  • 03613720192800 ()


  • Spinal fixation plate, non-bioabsorbable
4 HOLES LUMBOSACRAL PLATE Size 3 at 130°
MEDICREA INTERNATIONAL
B14011430
Not in Commercial Distribution

  • 03613720192794 ()


  • Spinal fixation plate, non-bioabsorbable
4 HOLES LUMBOSACRAL PLATE Size 3 at 115°
MEDICREA INTERNATIONAL
B14011415
Not in Commercial Distribution

  • 03613720192787 ()


  • Spinal fixation plate, non-bioabsorbable
4 HOLES LUMBOSACRAL PLATE Size 2 at 130°
MEDICREA INTERNATIONAL
B14011230
Not in Commercial Distribution

  • 03613720192770 ()


  • Spinal fixation plate, non-bioabsorbable
4 HOLES LUMBOSACRAL PLATE Size 2 at 115°
MEDICREA INTERNATIONAL
B14011215
Not in Commercial Distribution

  • 03613720192763 ()


  • Spinal fixation plate, non-bioabsorbable
4 HOLES LUMBOSACRAL PLATE Size 1 at 130°
MEDICREA INTERNATIONAL
B14011030
Not in Commercial Distribution

  • 03613720192756 ()


  • Spinal fixation plate, non-bioabsorbable
4 HOLES LUMBOSACRAL PLATE Size 1 at 115°
MEDICREA INTERNATIONAL
B14011015
Not in Commercial Distribution

  • 03613720192749 ()


  • Spinal fixation plate, non-bioabsorbable
CLAMP GLASSMAN STOMCH 2" AT JAW 9-1/2"
TELEFLEX INCORPORATED
IPN017577
In Commercial Distribution

  • 54026704791564 ()
  • 14026704791566 ()
P15687

  • Surgical soft-tissue manipulation forceps, scissors-like, reusable
SC AT PELHAM D AND C GYN PACK
Cardinal Health 200, LLC
SMA23DPPLA
In Commercial Distribution

  • 50195594187987 ()
  • 10195594187989 ()
SMA23DPPLA

  • Obstetrical/gynaecological surgical procedure kit, medicated
SC AT PELHAM D AND C GYN PACK
Cardinal Health 200, LLC
SMA23DPPLB
In Commercial Distribution

  • 50195594373793 ()
  • 10195594373795 ()
SMA23DPPLB

  • Obstetrical/gynaecological surgical procedure kit, medicated
Single non-flushing transducer with stopcocks at either ends
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
687276
In Commercial Distribution

  • 50886333672764 ()
  • 00886333672769 ()

  • non flusing DTX
687276

  • Invasive-pressure external transducer, single-use
ISE Internal Reference Packaged at 6 x 2L
POINTE SCIENTIFIC, INC.
HI790-REF
In Commercial Distribution

  • 00811727012401 ()
HI790-REF

  • Ion selective electrode (ISE) reference solution IVD, reagent
3.4mm Arthroscopic Sidebiter, 45deg. Angle at Tip, Left
Surgical Direct, Inc.
SD20759
In Commercial Distribution

  • B382SD207590 ()
SD20759

  • Endoscope sheath, reusable
Arthroscopic Side Biter, 45deg Angled at Tip, Right
Surgical Direct, Inc.
SD20709
In Commercial Distribution

  • B382SD207090 ()
SD20709

  • Endoscope sheath, reusable
Surgical Gown, Level 3, grippers at neck, 4 sets of grippers on tie closure at waist, patented Size 3XL
Lac-Mac Limited
005XFAB-3XL
In Commercial Distribution

  • 00627755057129 ()

  • Height: 58.25 Inch
  • Width: 31 Inch
005XFAB-3XL

  • Surgical gown, reusable
Surgical Gown, Level 3, grippers at neck, 4 sets of grippers on tie closure at waist, patented Size 2XL
Lac-Mac Limited
005XFAB-2XL
In Commercial Distribution

  • 00627755056122 ()

  • Height: 57.25 Inch
  • Width: 29 Inch
005XFAB-2XL

  • Surgical gown, reusable
Surgical Gown, Level 3, grippers at neck, 4 sets of grippers on tie closure at waist, patented Size XL
Lac-Mac Limited
005XFAB-XL
In Commercial Distribution

  • 00627755055125 ()

  • Height: 56.25 Inch
  • Width: 27 Inch
005XFAB-XL

  • Surgical gown, reusable
Surgical Gown, Level 3, grippers at neck, 4 sets of grippers on tie closure at waist, patented Size L
Lac-Mac Limited
005XFAB-L
In Commercial Distribution

  • 00627755054128 ()

  • Height: 55.25 Inch
  • Width: 25 Inch
005XFAB-L

  • Surgical gown, reusable
Surgical Gown, Level 3, grippers at neck, 4 sets of grippers on tie closure at waist, patented Size M
Lac-Mac Limited
005XFAB-M
In Commercial Distribution

  • 00627755053121 ()

  • Height: 54.25 Inch
  • Width: 23 Inch
005XFAB-M

  • Surgical gown, reusable
Surgical Gown, Level 3, grippers at neck, 4 sets of grippers on tie closure at waist, patented Size XS
Lac-Mac Limited
005XFAB-XS
In Commercial Distribution

  • 00627755051127 ()

  • Height: 52.25 Inch
  • Width: 19 Inch
005XFAB-XS

  • Surgical gown, reusable
Stimulation Lead, 65 cm length, Assembled, tray packed, and sterilized at Oscor Caribe, then final packaged at Oscor, Inc.
MAINSTAY MEDICAL LIMITED
7M8165-006
Not in Commercial Distribution

  • 05391527772279 ()
8165

  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection
Surgical Gown, Level 3, grippers at neck, 4 sets of grippers on tie closure at waist, patented Size S
Lac-Mac Limited
005XFAB-S
In Commercial Distribution

  • 00627755052124 ()

  • Height: 53.25 Inch
  • Width: 21 Inch
005XFAB-S

  • Surgical gown, reusable
Senn Retractor 16cm Dbl. Ended 3 Sharp Prongs At One End & 6.0 X 13mm Blade At The Other End
ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION
ASSI.MTK33316
In Commercial Distribution

  • 00841645133896 ()


  • Hand-held surgical retractor, reusable
Stimulation Lead, 45 cm length, Assembled and tray packed at Oscor Caribe, then sterilized and final packaged at Oscor, Inc.
MAINSTAY MEDICAL LIMITED
7M8145-005
In Commercial Distribution

  • 05391527772064 ()
8145

  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection
Wild Microscope Eye Protection Filter
AMERICAN MEDICAL SYSTEMS
0010-0047
In Commercial Distribution

  • 00878953000268 ()

  • Optical Density 5 at 532nm and 1064nm


  • Operator eye protection laser filter
Storz Microscope Eye Protection Filter
AMERICAN MEDICAL SYSTEMS
0010-0046
In Commercial Distribution

  • 00878953000251 ()

  • Optical Density 5 at 532nm and 1064nm


  • Operator eye protection laser filter
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