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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Gram Stain QC Slides with one specimen well
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020099 ()
  • 00816085020464 ()
0003231

  • Biological stain control IVD
Gram Stain QC Slide
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020082 ()
  • 00816085020457 ()
0003230

  • Biological stain control IVD
Gram Stain QC Slides (10 Pk)
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020082 ()
  • 00816085020440 ()
0003233

  • Biological stain control IVD
CELL-BOND Slides, 2 wells [15mm], red background
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023908 ()
  • 00816085020433 ()
0003222

  • General specimen microscopy slide IVD, single-use
CELL-BOND Slides, 2 Wells, black background
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023915 ()
  • 00816085020426 ()
0003221

  • General specimen microscopy slide IVD, single-use
CELL-BOND Slides, 1 Well, black background
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023922 ()
  • 00816085020419 ()
0003220

  • General specimen microscopy slide IVD, single-use
CELL-BOND Slides, 1 Well, blue background
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023939 ()
  • 00816085020402 ()
0003219

  • General specimen microscopy slide IVD, single-use
CELL-BOND Slides, 2 Red Wells
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023946 ()
  • 00816085020396 ()
0003218

  • General specimen microscopy slide IVD, single-use
CELL-BOND Slides, 1 Well, black background
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023953 ()
  • 00816085020389 ()
0003217

  • General specimen microscopy slide IVD, single-use
CELL-BOND Slides, 1 Well, white background
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023960 ()
  • 00816085020372 ()
0003215

  • General specimen microscopy slide IVD, single-use
NPC-67 Neutralizing Buffer, 8x250mL
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020365 ()
0003941

  • Sputum specimen liquefaction/decontamination kit IVD
CELL-BOND Slides, 1 well, black background
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023977 ()
  • 00816085020358 ()
0003216

  • General specimen microscopy slide IVD, single-use
CELL-BOND Slides, 1 well, black background
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023984 ()
  • 00816085020341 ()
0003224

  • General specimen microscopy slide IVD, single-use
CELL-BOND Slides, 1 well, black background
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020334 ()
S003224

  • General specimen microscopy slide IVD, single-use
Mycology Quality Control Slides
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020303 ()
  • 00816085020310 ()
0003265

  • Biological stain control IVD
Mycology Quality Control Slide
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020303 ()
0003265S

  • Biological stain control IVD
Trichomonas Quality Control Slide
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020280 ()
  • 00816085020297 ()
0003268

  • Biological stain control IVD
NAC-PAC N30 Tray
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020273 ()


  • Sputum specimen liquefaction/decontamination kit IVD
NAC-PAC RED (3.0%), 50mL
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020266 ()


  • Sputum specimen liquefaction/decontamination kit IVD
NPC-67 Neutralizing Buffer, 250mL bottle
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020259 ()


  • Sputum specimen liquefaction/decontamination kit IVD
PROTO-FIX QC Slide
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020181 ()
0003255S

  • Biological stain control IVD
Nocardia Stain Control Slides
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020167 ()
0003248S

  • Biological stain control IVD
CELL-BOND Slide, 1 Red well, no background
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020105 ()
S003223

  • General specimen microscopy slide IVD, single-use
CELL-BOND Slides, 2 wells [15mm], red background
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020075 ()
S003222

  • General specimen microscopy slide IVD, single-use
Bone tap 6.7 mm with stop for 28 mm screw
Inion Oy
0
In Commercial Distribution

  • M224INS95759 ()
INS-9575

  • Bone tap, reusable
Bone tap 6.7 mm with stop for 25 mm screw
Inion Oy
0
In Commercial Distribution

  • M224INS95749 ()
INS-9574

  • Bone tap, reusable
Bone tap 6.7 mm with stop for 22 mm screw
Inion Oy
0
In Commercial Distribution

  • M224INS95739 ()
INS-9573

  • Bone tap, reusable
Bone tap 6.0 mm with stop for 31 mm screw
Inion Oy
0
In Commercial Distribution

  • M224INS95729 ()
INS-9572

  • Bone tap, reusable
Bone tap 6.0 mm with stop for 27 mm screw
Inion Oy
0
In Commercial Distribution

  • M224INS95719 ()
INS-9571

  • Bone tap, reusable
Bone tap 6.0 mm with stop for 25 mm screw
Inion Oy
0
In Commercial Distribution

  • M224INS95709 ()
INS-9570

  • Bone tap, reusable
Bone tap 6.0 mm with stop for 22 mm screw
Inion Oy
0
In Commercial Distribution

  • M224INS95699 ()
INS-9569

  • Bone tap, reusable
Screw driver shaft
Inion Oy
0
In Commercial Distribution

  • M224INS95599 ()
INS-9559

  • Surgical screwdriver, reusable
Screw driver for temporary fixation screw
Inion Oy
0
In Commercial Distribution

  • M224INS95589 ()
INS-9558

  • Surgical screwdriver, reusable
Plate holder
Inion Oy
0
In Commercial Distribution

  • M224INS95569 ()
INS-9556

  • Surgical implant/trial-implant/sizer holder, reusable
Bone tap 5.0 mm with stop for 16 mm screw
Inion Oy
0
In Commercial Distribution

  • M224INS95519 ()
INS-9551

  • Bone tap, reusable
Bone tap 5.0 mm with stop for 14 mm screw
Inion Oy
0
In Commercial Distribution

  • M224INS95509 ()
INS-9550

  • Bone tap, reusable
Bone tap 5.0 mm with stop for 12 mm screw
Inion Oy
0
In Commercial Distribution

  • M224INS95499 ()
INS-9549

  • Bone tap, reusable
Bone tap 4.5 mm with stop for 16 mm screw
Inion Oy
0
In Commercial Distribution

  • M224INS95489 ()
INS-9548

  • Bone tap, reusable
Bone tap 4.5 mm with stop for 14 mm screw
Inion Oy
0
In Commercial Distribution

  • M224INS95479 ()
INS-9547

  • Bone tap, reusable
Bone tap 4.5 mm with stop for 12 mm screw
Inion Oy
0
In Commercial Distribution

  • M224INS95469 ()
INS-9546

  • Bone tap, reusable
Temporary fixation screw
Inion Oy
0
In Commercial Distribution

  • M224INS95279 ()
INS-9527

  • Orthopaedic fixation implant alignment tool
Screwdriver blade (custom coupling)
Inion Oy
0
In Commercial Distribution

  • M224INS92739 ()
INS-9273

  • Surgical screwdriver, reusable
2.0 mm self-drilling bone tap (custom coupling)
Inion Oy
0
In Commercial Distribution

  • M224INS92729 ()
INS-9272

  • Bone tap, reusable
1.5 mm self-drilling bone tap (custom coupling)
Inion Oy
0
In Commercial Distribution

  • M224INS92719 ()
INS-9271

  • Bone tap, reusable
Screwdriver blade (pentagonal coupling)
Inion Oy
0
Not in Commercial Distribution

  • M224INS92679 ()
INS-9267

  • Surgical screwdriver, reusable
2.8 mm bone tap long (pentagonal coupling)
Inion Oy
0
In Commercial Distribution

  • M224INS92669 ()
INS-9266

  • Bone tap, reusable
4.5 mm bone tap
Inion Oy
0
In Commercial Distribution

  • M224INS90839 ()
INS-9083

  • Bone tap, reusable
3.1 mm bone tap with 42 mm stop (AO-bayo)
Inion Oy
0
In Commercial Distribution

  • M224INS90829 ()
INS-9082

  • Bone tap, reusable
2.8 mm bone tap with 42 mm stop (man. AO)
Inion Oy
0
In Commercial Distribution

  • M224INS90819 ()
INS-9081

  • Bone tap, reusable
2.5 mm bone tap with 32 mm stop (AO-bayo)
Inion Oy
0
In Commercial Distribution

  • M224INS90809 ()
INS-9080

  • Bone tap, reusable
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