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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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Focus - 00810005662116

Pedicle Screw Case 1 Lid. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PD-1000C-101
In Commercial Distribution

  • 00810005662116 ()


  • Surgical instrument/implant rack

Focus - 00810005662109

Pedicle Screw Case 1 Base, Implants. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PD-1000C-201
In Commercial Distribution

  • 00810005662109 ()


  • Surgical instrument/implant rack

Foot Switch - 00817688021797

No Description
I.C. MEDICAL, INC.
ICM-000-0447
In Commercial Distribution

  • 00817688021797 ()


  • Surgical plume evacuation system

Foramen Ovale Depth Electrode - 00841823103543

No Description
Ad-Tech Medical Instrument Corporation
FO06K-SP05X-000
In Commercial Distribution

  • 90841823103546 ()
  • 00841823103543 ()
FO06K-SP05X-000

  • Depth electrode

Foramen Ovale Depth Electrode - 00841823103529

No Description
Ad-Tech Medical Instrument Corporation
FO04K-SP26X-A00
In Commercial Distribution

  • 00841823103529 ()
FO04K-SP26X-A00

  • Depth electrode

Foramen Ovale Depth Electrode - 00841823103512

No Description
Ad-Tech Medical Instrument Corporation
FO04K-SP05X-000
In Commercial Distribution

  • 90841823103515 ()
  • 00841823103512 ()
FO04K-SP05X-000

  • Depth electrode

Foramen Ovale Depth Electrode - 00841823103505

No Description
Ad-Tech Medical Instrument Corporation
FO03K-SP05X-000
In Commercial Distribution

  • 90841823103508 ()
  • 00841823103505 ()
FO03K-SP05X-000

  • Depth electrode

Foramen Ovale Depth Electrode - 00841823103550

No Description
Ad-Tech Medical Instrument Corporation
FO06K-SP10X-000
In Commercial Distribution

  • 90841823103553 ()
  • 00841823103550 ()
FO06K-SP10X-000

  • Depth electrode

Foramen Ovale Depth Electrode - 00841823103536

No Description
Ad-Tech Medical Instrument Corporation
FO05K-SP05X-000
In Commercial Distribution

  • 90841823103539 ()
  • 00841823103536 ()
FO05K-SP05X-000

  • Depth electrode

Frame adapter thumb screw - 07290114061407

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Frame adapter thumb screw
In Commercial Distribution

  • 07290114061407 ()
700-001330-00

  • Depth electrode

Frame adapter thumb screw - Pack of 3 - 37290114061408

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Frame adapter thumb screw - Pack of 3
In Commercial Distribution

  • 37290114061408 ()
700-001330-03

  • Depth electrode

Fresh Cells - 30014613338420

Super-BGMK FLK 225 SQ CM
DIAGNOSTIC HYBRIDS, INC.
70-T225
In Commercial Distribution

  • 30014613338420 ()
70-T225

  • Cell culture line IVD

Fresh Cells - 30014613338413

BGMK FLK 225 SQ CM
DIAGNOSTIC HYBRIDS, INC.
53-T225
In Commercial Distribution

  • 30014613338413 ()
53-T225

  • Cell culture line IVD

Fresh Cells - 30014613338307

RHMK FLK 225
DIAGNOSTIC HYBRIDS, INC.
49-T225DH
In Commercial Distribution

  • 30014613338307 ()
49-T225DH

  • Cell culture line IVD

Fresh Cells - 30014613338260

MDCK FLASK 225 SQ CM
DIAGNOSTIC HYBRIDS, INC.
83-T225DH
In Commercial Distribution

  • 30014613338260 ()
83-T225DH

  • Cell culture line IVD

Fresh Cells - 30014613333364

HEP-2 W96/96
DIAGNOSTIC HYBRIDS, INC.
57-9696
In Commercial Distribution

  • 30014613333364 ()
57-9696

  • Cell culture line IVD

Fresh Cells - 30014613333357

HEP-2 MWP 4848
DIAGNOSTIC HYBRIDS, INC.
57-4848
In Commercial Distribution

  • 30014613333357 ()
57-4848

  • Cell culture line IVD

Fresh Cells - 30014613333340

HEP2 PLATE W48/24F
DIAGNOSTIC HYBRIDS, INC.
57-4824
In Commercial Distribution

  • 30014613333340 ()
57-4824

  • Cell culture line IVD

Fresh Cells - 30014613333333

HEP2 PLATE W24/24F
DIAGNOSTIC HYBRIDS, INC.
57-2424
In Commercial Distribution

  • 30014613333333 ()
57-2424

  • Cell culture line IVD

Fresh Cells - 30014613333326

HEP2 PLATE W24/06F
DIAGNOSTIC HYBRIDS, INC.
57-2406
In Commercial Distribution

  • 30014613333326 ()
57-2406

  • Cell culture line IVD

Fresh Cells - 30014613333319

HEP2 TUBE
DIAGNOSTIC HYBRIDS, INC.
57-0600
In Commercial Distribution

  • 30014613333319 ()
57-0600

  • Cell culture line IVD

Fresh Cells - 30014613333302

HEP2 SV/CS
DIAGNOSTIC HYBRIDS, INC.
57-0102
In Commercial Distribution

  • 30014613333302 ()
57-0102

  • Cell culture line IVD

Fresh Cells - 30014613333296

HEP-2 FROZEN SUSP. 50 MER
DIAGNOSTIC HYBRIDS, INC.
57-00050
In Commercial Distribution

  • 30014613333296 ()
57-00050

  • Cell culture line IVD

Fresh Cells - 30014613333289

A549 FLK 150 SQ CM
DIAGNOSTIC HYBRIDS, INC.
56-T150
In Commercial Distribution

  • 30014613333289 ()
56-T150

  • Cell culture line IVD

Fresh Cells - 30014613333272

A549 FLK 75 SQ CM
DIAGNOSTIC HYBRIDS, INC.
56-T075
In Commercial Distribution

  • 30014613333272 ()
56-T075

  • Cell culture line IVD

Fresh Cells - 30014613333265

A549 FLASK 25 SQ CM
DIAGNOSTIC HYBRIDS, INC.
56-T025
In Commercial Distribution

  • 30014613333265 ()
56-T025

  • Cell culture line IVD

Fresh Cells - 30014613333258

A549 PLATE W96/96F
DIAGNOSTIC HYBRIDS, INC.
56-9696
In Commercial Distribution

  • 30014613333258 ()
56-9696

  • Cell culture line IVD

Fresh Cells - 30014613333241

A549 PLATE W96/60F
DIAGNOSTIC HYBRIDS, INC.
56-9660
In Commercial Distribution

  • 30014613333241 ()
56-9660

  • Cell culture line IVD

Fresh Cells - 30014613333234

A549 CELLS MWP W96/32 CUST
DIAGNOSTIC HYBRIDS, INC.
56-9632C
In Commercial Distribution

  • 30014613333234 ()
56-9632C

  • Cell culture line IVD

Fresh Cells - 30014613333227

A549 CELLS MWP W96/24 CUST
DIAGNOSTIC HYBRIDS, INC.
56-9624C
In Commercial Distribution

  • 30014613333227 ()
56-9624C

  • Cell culture line IVD

Fresh Cells - 30014613333210

A549 PLATE W48/48F
DIAGNOSTIC HYBRIDS, INC.
56-4848
In Commercial Distribution

  • 30014613333210 ()
56-4848

  • Cell culture line IVD

Fresh Cells - 30014613333203

A549 W48/24
DIAGNOSTIC HYBRIDS, INC.
56-4824
In Commercial Distribution

  • 30014613333203 ()
56-4824

  • Cell culture line IVD

Fresh Cells - 30014613333197

A549 W48/12
DIAGNOSTIC HYBRIDS, INC.
56-4812
In Commercial Distribution

  • 30014613333197 ()
56-4812

  • Cell culture line IVD

Fresh Cells - 30014613333180

A549 W24/24
DIAGNOSTIC HYBRIDS, INC.
56-2424
In Commercial Distribution

  • 30014613333180 ()
56-2424

  • Cell culture line IVD

Fresh Cells - 30014613333173

A549 W24/18
DIAGNOSTIC HYBRIDS, INC.
56-2418
In Commercial Distribution

  • 30014613333173 ()
56-2418

  • Cell culture line IVD

Fresh Cells - 30014613333166

A549 W24/12
DIAGNOSTIC HYBRIDS, INC.
56-2412
In Commercial Distribution

  • 30014613333166 ()
56-2412

  • Cell culture line IVD

Fresh Cells - 30014613333159

A549 W24/06
DIAGNOSTIC HYBRIDS, INC.
56-2406
In Commercial Distribution

  • 30014613333159 ()
56-2406

  • Cell culture line IVD

Fresh Cells - 30014613333142

A549 6 WELL 6 FILL PLATE
DIAGNOSTIC HYBRIDS, INC.
56-0606
In Commercial Distribution

  • 30014613333142 ()
56-0606

  • Cell culture line IVD

Fresh Cells - 30014613333135

A549 TUBE LIGHT DENSITY
DIAGNOSTIC HYBRIDS, INC.
56-0600L
In Commercial Distribution

  • 30014613333135 ()
56-0600L

  • Cell culture line IVD

Fresh Cells - 30014613333128

A549 TUBE
DIAGNOSTIC HYBRIDS, INC.
56-0600
In Commercial Distribution

  • 30014613333128 ()
56-0600

  • Cell culture line IVD
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