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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Battalion Lateral Spacer, PEEK, 15°, 26 mm Wide, 16 x 35 mm
ALPHATEC SPINE, INC.
27024-1480-S
In Commercial Distribution

  • 00190376043180 ()

  • Height: 16 Millimeter
  • Length: 35 Millimeter
  • Width: 26 Millimeter
  • Angle: 15 degree


  • Metal-polymer composite spinal interbody fusion cage
Battalion Lateral Spacer, PEEK, 15°, 26 mm Wide, 14 x 35 mm
ALPHATEC SPINE, INC.
27024-1478-S
In Commercial Distribution

  • 00190376043173 ()

  • Width: 26 Millimeter
  • Angle: 15 degree
  • Length: 35 Millimeter
  • Height: 14 Millimeter


  • Metal-polymer composite spinal interbody fusion cage
Battalion Lateral Spacer, PEEK, 15°, 26 mm Wide, 12 x 35 mm
ALPHATEC SPINE, INC.
27024-1476-S
In Commercial Distribution

  • 00190376043166 ()

  • Length: 35 Millimeter
  • Height: 12 Millimeter
  • Angle: 15 degree
  • Width: 26 Millimeter


  • Metal-polymer composite spinal interbody fusion cage
Battalion Lateral Spacer, PEEK, 10°, 26 mm Wide, 10 x 35 mm
ALPHATEC SPINE, INC.
27024-1474-S
In Commercial Distribution

  • 00190376043159 ()

  • Length: 35 Millimeter
  • Angle: 10 degree
  • Height: 10 Millimeter
  • Width: 26 Millimeter


  • Metal-polymer composite spinal interbody fusion cage
Battalion Lateral Spacer, PEEK, 6°, 26 mm Wide, 8 x 35 mm
ALPHATEC SPINE, INC.
27024-1472-S
In Commercial Distribution

  • 00190376043142 ()

  • Width: 26 Millimeter
  • Height: 8 Millimeter
  • Length: 35 Millimeter
  • Angle: 6 degree


  • Metal-polymer composite spinal interbody fusion cage
35 (W) x 26 (D) x 16mm (H) x 6° (A) Trial
CURITEVA, INC.
C255-429
In Commercial Distribution

  • B648C2554290 ()

  • Width: 35 Millimeter
  • Depth: 26 Millimeter
  • Height: 16 Millimeter
  • Angle: 6 degree


  • Surgical implant/trial-implant/sizer holder, reusable
35 (W) x 26 (D) x 14mm (H) x 6° (A) Trial
CURITEVA, INC.
C255-427
In Commercial Distribution

  • B648C2554270 ()

  • Width: 35 Millimeter
  • Depth: 26 Millimeter
  • Height: 14 Millimeter
  • Angle: 6 degree


  • Surgical implant/trial-implant/sizer holder, reusable
35 (W) x 26 (D) x 12mm (H) x 6° (A) Trial
CURITEVA, INC.
C255-425
In Commercial Distribution

  • B648C2554250 ()

  • Width: 35 Millimeter
  • Depth: 26 Millimeter
  • Height: 12 Millimeter
  • Angle: 6 degree


  • Surgical implant/trial-implant/sizer holder, reusable
35 (W) x 26 (D) x 10mm (H) x 6° (A) Trial
CURITEVA, INC.
C255-423
In Commercial Distribution

  • B648C2554230 ()

  • Width: 35 Millimeter
  • Depth: 26 Millimeter
  • Height: 10 Millimeter
  • Angle: 6 degree


  • Surgical implant/trial-implant/sizer holder, reusable
35 (W) x 26 (D) x 20mm (H) x 12° (A) Trial
CURITEVA, INC.
C255-4225
In Commercial Distribution

  • B648C25542250 ()

  • Width: 35 Millimeter
  • Depth: 26 Millimeter
  • Height: 20 Millimeter
  • Angle: 12 degree


  • Surgical implant/trial-implant/sizer holder, reusable
35 (W) x 26 (D) x 18mm (H) x 12° (A) Trial
CURITEVA, INC.
C255-4223
In Commercial Distribution

  • B648C25542230 ()

  • Width: 35 Millimeter
  • Depth: 26 Millimeter
  • Height: 18 Millimeter
  • Angle: 12 degree


  • Surgical implant/trial-implant/sizer holder, reusable
35 (W) x 26 (D) x 16mm (H) x 12° (A) Trial
CURITEVA, INC.
C255-4221
In Commercial Distribution

  • B648C25542210 ()

  • Width: 35 Millimeter
  • Depth: 26 Millimeter
  • Height: 16 Millimeter
  • Angle: 12 degree


  • Surgical implant/trial-implant/sizer holder, reusable
35 (W) x 26 (D) x 14mm (H) x 12° (A) Trial
CURITEVA, INC.
C255-4219
In Commercial Distribution

  • B648C25542190 ()

  • Width: 35 Millimeter
  • Depth: 26 Millimeter
  • Height: 14 Millimeter
  • Angle: 12 degree


  • Surgical implant/trial-implant/sizer holder, reusable
35 (W) x 26 (D) x 12mm (H) x 12° (A) Trial
CURITEVA, INC.
C255-4217
In Commercial Distribution

  • B648C25542170 ()

  • Width: 35 Millimeter
  • Depth: 26 Millimeter
  • Height: 12 Millimeter
  • Angle: 12 degree


  • Surgical implant/trial-implant/sizer holder, reusable
35 (W) x 26 (D) x 10mm (H) x 12° (A) Trial
CURITEVA, INC.
C255-4215
In Commercial Distribution

  • B648C25542150 ()

  • Width: 35 Millimeter
  • Depth: 26 Millimeter
  • Height: 10 Millimeter
  • Angle: 12 degree


  • Surgical implant/trial-implant/sizer holder, reusable
35 (W) x 26 (D) x 20mm (H) x 6° (A) Trial
CURITEVA, INC.
C255-4213
In Commercial Distribution

  • B648C25542130 ()

  • Width: 35 Millimeter
  • Depth: 26 Millimeter
  • Height: 20 Millimeter
  • Angle: 6 degree


  • Surgical implant/trial-implant/sizer holder, reusable
35 (W) x 26 (D) x 18mm (H) x 6° (A) Trial
CURITEVA, INC.
C255-4211
In Commercial Distribution

  • B648C25542110 ()

  • Width: 35 Millimeter
  • Depth: 26 Millimeter
  • Height: 18 Millimeter
  • Angle: 6 degree


  • Surgical implant/trial-implant/sizer holder, reusable
35 (W) x 26 (D) x 08mm (H) x 6° (A) Trial
CURITEVA, INC.
C255-421
In Commercial Distribution

  • B648C2554210 ()

  • Width: 35 Millimeter
  • Depth: 26 Millimeter
  • Height: 8 Millimeter
  • Angle: 6 degree


  • Surgical implant/trial-implant/sizer holder, reusable
CODMAN CERTAS® Plus Programmable Valve Inline Small Valve with SIPHONGUARD®, Accessories and Unitized BACTISEAL® Catheter Includes: BACTISEAL Ventricular Catheter, BACTISEAL Unitized Distal Catheter, Priming Adapter, Right Angle Adapter and Information Manual
Integra LifeSciences Switzerland Sàrl
828817PL
In Commercial Distribution

  • 10381780529255 ()
82-8817PL

  • Ventriculo-peritoneal/atrial shunt
CODMAN CERTAS® Plus Programable Valve Inline Small Valve with Accessories and Unitized BACTISEAL® Catheter Includes: BACTISEAL Ventricular Catheter, BACTISEAL Unitized Distal Catheter, Priming Adapter, Right Angle Adapter and Information Manual
Integra LifeSciences Switzerland Sàrl
828813PL
In Commercial Distribution

  • 10381780529231 ()
82-8813PL

  • Ventriculo-peritoneal/atrial shunt
No Description
Roche Molecular Systems, Inc.
09040552190
In Commercial Distribution

  • 00875197006896 ()
09040552190

  • Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Roche Molecular Systems, Inc.
09040544190
In Commercial Distribution

  • 00875197006889 ()
09040544190

  • Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Roche Molecular Systems, Inc.
07460171190
In Commercial Distribution

  • 00875197005769 ()
07460171190

  • Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Roche Molecular Systems, Inc.
07460155190
In Commercial Distribution

  • 00875197005752 ()
07460155190

  • Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Roche Molecular Systems, Inc.
05235898190
In Commercial Distribution

  • 00875197003260 ()
05235898190

  • Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Roche Molecular Systems, Inc.
05235880190
In Commercial Distribution

  • 00875197003253 ()
05235880190

  • Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Roche Molecular Systems, Inc.
05235871190
In Commercial Distribution

  • 00875197003246 ()
05235871190

  • Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Roche Molecular Systems, Inc.
05235863190
In Commercial Distribution

  • 00875197003239 ()
05235863190

  • Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Roche Molecular Systems, Inc.
05235855190
In Commercial Distribution

  • 00875197003222 ()
05235855190

  • Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Roche Molecular Systems, Inc.
05235839190
In Commercial Distribution

  • 00875197003208 ()
05235839190

  • Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Roche Molecular Systems, Inc.
05235812190
In Commercial Distribution

  • 00875197003192 ()
05235812190

  • Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Roche Molecular Systems, Inc.
05235804190
In Commercial Distribution

  • 00875197003185 ()
05235804190

  • Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Roche Molecular Systems, Inc.
05235782190
In Commercial Distribution

  • 00875197003178 ()
05235782190

  • Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Hologic, Inc.
GENFIND DNA EXTRACTION KIT
Not in Commercial Distribution

  • 15420045504271 ()
95-449

  • Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Hologic, Inc.
Cervista HTA System Computer
Not in Commercial Distribution

  • 15420045501065 ()


  • Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Hologic, Inc.
Cervista Manual System Computer
Not in Commercial Distribution

  • 15420045501058 ()


  • Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Hologic, Inc.
Cervista HTA System
Not in Commercial Distribution

  • 15420045500969 ()


  • Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Hologic, Inc.
Cervista HTA System
Not in Commercial Distribution

  • 15420045500952 ()


  • Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Hologic, Inc.
HPV 16 18
Not in Commercial Distribution

  • 15420045500167 ()
95-439

  • Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Hologic, Inc.
HPV HR (768 Reactions)
Not in Commercial Distribution

  • 15420045500150 ()
PRD-00804

  • Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Hologic, Inc.
HPV HR (96 Reactions)
Not in Commercial Distribution

  • 15420045500143 ()
95-438

  • Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)
Aptima® GT HPV 16 18/45 Genotype Assay Calibrators Kit.
Hologic, Inc.
KIT, APTIMA HPV 16 18/45, CALS IVD
In Commercial Distribution

  • 15420045500136 ()
303235

  • Human papillomavirus (HPV) high-risk strain nucleic acid IVD, calibrator
Aptima® HPV 16 18/45 Genotype Assay, 100 test, box 2 of 2 (15°C to 30°C box).
Hologic, Inc.
KIT, APTIMA HPV 16 18/45, 100 RT IVD
In Commercial Distribution

  • 15420045500129 ()
303231

  • Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)
Aptima® HPV 16 18/45 Genotype Assay, 100 test, box 1 of 2 (2°C to 8°C box).
Hologic, Inc.
KIT, APTIMA HPV 16 18/45, 100 REF IVD
In Commercial Distribution

  • 15420045500112 ()
303230

  • Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)
Aptima® HPV Assay, 100 test, box 2 of 2 (15°C to 30°C box).
Hologic, Inc.
KIT, BX 2 (RT) HPV,100-T,AS, US IVD
In Commercial Distribution

  • 15420045500105 ()
303572

  • Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)
Aptima® HPV Assay, 100 test, box 1 of 2 (2°C to 8°C box).
Hologic, Inc.
KIT, BX 1(REF) HPV,100-T, AS, US IVD
In Commercial Distribution

  • 15420045500099 ()
303573

  • Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)
Aptima® HPV Assay Controls Kit.
Hologic, Inc.
KIT,HPV,APTIMA, CONTROLS, IVD
In Commercial Distribution

  • 15420045500082 ()
303011

  • Human papillomavirus (HPV) high-risk strain nucleic acid IVD, control
Aptima® HPV Assay Calibrators Kit.
Hologic, Inc.
KIT,HPV,APTIMA, CALIBRATORS, IVD
In Commercial Distribution

  • 15420045500075 ()
303010

  • Human papillomavirus (HPV) high-risk strain nucleic acid IVD, calibrator
Aptima® HPV Assay, 250 test, box 2 of 2 (15°C to 30°C box).
Hologic, Inc.
KIT,HPV,APTIMA,250 TEST,ROOM TEMP, IVD
In Commercial Distribution

  • 15420045500068 ()
302885

  • Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)
Aptima® HPV Assay, 250 test, box 1 of 2 (2°C to 8°C box).
Hologic, Inc.
KIT, HPV, APTIMA, 250 TEST, REFRIG, IVD
In Commercial Distribution

  • 15420045500051 ()
302883

  • Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)
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