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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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D3 Ultra - 30014613330356

D3 Ultra DFA Respiratory Virus ID Set
DIAGNOSTIC HYBRIDS, INC.
01-010007.V2
In Commercial Distribution

  • 30014613330356 ()
01-010007.V2

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay

D3 Ultra - 30014613330349

D3 Ultra DFA Parainfluenza Reagent Set
DIAGNOSTIC HYBRIDS, INC.
01-010006.V2
In Commercial Distribution

  • 30014613330349 ()
01-010006.V2

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay

D3 Ultra - 30014613330325

De Ultra DFA Influenza A/Influenza B Reagent Set
DIAGNOSTIC HYBRIDS, INC.
01-010004.V2
In Commercial Distribution

  • 30014613330325 ()
01-010004.V2

  • Influenza A/B virus antigen IVD, kit, fluorescent immunoassay

D3 Ultra - 30014613330318

D3 Ultra DFA RSV Reagent Set
DIAGNOSTIC HYBRIDS, INC.
01-010003.V2
In Commercial Distribution

  • 30014613330318 ()
01-010003.V2

  • Respiratory syncytial virus (RSV) antigen IVD, kit, fluorescent immunoassay

D3 Ultra - 30014613330301

D3 Ultra DFA Respiratory Virus Shell Vial Screening Set
DIAGNOSTIC HYBRIDS, INC.
01-010002.V2
In Commercial Distribution

  • 30014613330301 ()
01-010002.V2

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay

D3 Ultra - 30014613330295

D3 Ultra DFA Respiratory Virus Direct Specimen Screening set
DIAGNOSTIC HYBRIDS, INC.
01-010001.V2
In Commercial Distribution

  • 30014613330295 ()
01-010001.V2

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay

D3 Ultra - 30014613330288

D3 Ultra DFA Respiratory Virus Screening and ID kit
DIAGNOSTIC HYBRIDS, INC.
01-010000.V2
In Commercial Distribution

  • 30014613330288 ()
01-010000.V2

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay

ELVIS - 30014613330202

ELVIS SOL 3, 12ML
DIAGNOSTIC HYBRIDS, INC.
00-013012.V2
In Commercial Distribution

  • 30014613330202 ()
00-013012.V2

  • Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, kit, fluorescent immunoassay

ELVIS - 30014613330196

ELVIS SOL 3, 3ML
DIAGNOSTIC HYBRIDS, INC.
00-013003.V2
In Commercial Distribution

  • 30014613330196 ()
00-013003.V2

  • Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, kit, fluorescent immunoassay

LiDCO Ltd - 05060110522194

* INACTIVE Software Upgrade, LiDCO LXI v2 for ICU Medical only (b1326)
LIDCO LIMITED
Li11057
Not in Commercial Distribution

  • 05060110522194 ()
Li11057

  • General-purpose multi-parameter bedside monitor

De Mayo V2® Knee Positioner® - 00696588006796

Loaner De Mayo V2®/V2E® Knee Positioner® Clamp
Innovative Medical Products, Inc
114-CL LOANER
In Commercial Distribution

  • 00696588006796 ()
114-CL LOANER

  • Medical table clamp

De Mayo V2®/V2E® Knee Positioner® - 00696588005393

Evaluation De Mayo V2®/V2E® Knee Positioner® Clamp
Innovative Medical Products, Inc
114-CL EVAL
In Commercial Distribution

  • 00696588005393 ()
114-CL EVAL

  • Medical table clamp

De Mayo V2®/V2E® Knee Positioner® - 00696588005386

Demo De Mayo V2®/V2E® Knee Positioner® Clamp
Innovative Medical Products, Inc
114-CL DEMO
In Commercial Distribution

  • 00696588005386 ()
114-CL DEMO

  • Medical table clamp

KINCISE - 10603295552772

KINCISE MAKE TO ORDER V2 EMPHASYS STRAIGHT SHELL/LINER IMPACTOR LONG
DEPUY ORTHOPAEDICS, INC.
2999-66-993
In Commercial Distribution

  • 10603295552772 ()
299966993

  • Orthopaedic implant impactor, reusable

KINCISE - 10603295552758

KINCISE MAKE TO ORDER V2 EMPHASYS STRAIGHT SHELL/LINER IMPACTOR SHORT
DEPUY ORTHOPAEDICS, INC.
2999-66-994
In Commercial Distribution

  • 10603295552758 ()
299966994

  • Orthopaedic implant impactor, reusable

LIGHTFORCE - 00190446897910

Trade-In 800um SHP v2 Assy LightForce - less than 5 yrs old
DJO, LLC
PRD-000758-010-00-L-L5
In Commercial Distribution

  • 00190446897910 ()


  • Musculoskeletal/physical therapy laser beam guide, transcutaneous

LIGHTFORCE - 00190446897903

Trade-In 800um SHP v2 Assy LightForce - more than 5 yrs old
DJO, LLC
PRD-000758-010-00-L-G5
In Commercial Distribution

  • 00190446897903 ()


  • Musculoskeletal/physical therapy laser beam guide, transcutaneous

Vital Signs - 10885403260308

Diagnostic Cardiology Leadwire, Dedicated Banana, AHA, 26 in / 66 cm, V2
Carefusion Finland 320 Oy
2020558-006
Not in Commercial Distribution

  • 10885403260308 ()
2020558-006

  • Electrocardiographic lead set, reusable

AGC V2 MILLENNIUM INSTRUMENT - 05019279496839

No Description
Biomet Uk Ltd
32-468456
In Commercial Distribution

  • 05019279496839 ()

  • 80MM
32-468456

  • Knee femur prosthesis trial, reusable

AGC V2 MILLENNIUM INSTRUMENT - 05019279496730

No Description
Biomet Uk Ltd
32-468451
In Commercial Distribution

  • 05019279496730 ()

  • 55mm
32-468451

  • Knee femur prosthesis trial, reusable

AGC V2 MILLENNIUM INSTRUMENT - 05019279496716

No Description
Biomet Uk Ltd
32-468446
In Commercial Distribution

  • 05019279496716 ()

  • 80MM
32-468446

  • Knee femur prosthesis trial, reusable

AGC V2 MILLENNIUM INSTRUMENT - 05019279469444

No Description
Biomet Uk Ltd
32-401122
In Commercial Distribution

  • 05019279469444 ()
32-401122

  • Orthopaedic inorganic implant inserter/extractor, reusable

AGC V2 MILLENNIUM INSTRUMENT - 05019279495009

No Description
Biomet Uk Ltd
32-467602
In Commercial Distribution

  • 05019279495009 ()
32-467602

  • Bone-resection orthopaedic reamer, reusable

AGC V2 MILLENNIUM INSTRUMENT - 05019279493739

No Description
Biomet Uk Ltd
32-467263
In Commercial Distribution

  • 05019279493739 ()
32-467263

  • Orthopaedic prosthesis implantation positioning instrument, reusable

AGC V2 MILLENNIUM INSTRUMENT - 05019279493708

No Description
Biomet Uk Ltd
32-467261
In Commercial Distribution

  • 05019279493708 ()

  • 6MM
32-467261

  • Fluted surgical drill bit, reusable

V2 ICE Probe SL - 00868390000204

The V2 ICE Probe SL (2.4 mm) is a single use, disposable probe designed for use with the Visica 2 Treatment System. The primary components of the V2 ICE Probe consists of a surgical stainless steel probe with an electrical warming component and an integrated T-Type thermocouple for internal temperature feedback. The V2 ICE Probe temperatures are internally and continuously monitored by the Visica 2 Console.
SANARUS TECHNOLOGIES, INC.
VP0601
In Commercial Distribution

  • 00868390000204 ()
VP0601

  • Cryosurgical set

Threshold V2 Pedicle Screw - M7405514550

Pedicle Screw
SPINEOLOGY INC.
10-10-80-86
Not in Commercial Distribution

  • M7405514550 ()

  • 50x4.5
  • Length: 50 Millimeter
551-4550

  • Bone-screw internal spinal fixation system rod

Threshold V2 Pedicle Screw - M7405514545

Pedicle Screw
SPINEOLOGY INC.
10-10-80-85
Not in Commercial Distribution

  • M7405514545 ()

  • 45x4.5
  • Length: 45 Millimeter
551-4545

  • Bone-screw internal spinal fixation system rod

Threshold V2 Pedicle Screw - M7405514540

Pedicle Screw
SPINEOLOGY INC.
10-10-80-84
Not in Commercial Distribution

  • M7405514540 ()

  • Length: 40 Millimeter
  • 40x4.5
551-4540

  • Bone-screw internal spinal fixation system rod

Threshold V2 Pedicle Screw - M7405514535

Pedicle Screw
SPINEOLOGY INC.
10-10-80-83
Not in Commercial Distribution

  • M7405514535 ()

  • 35x4.5
  • Length: 35 Millimeter
551-4535

  • Bone-screw internal spinal fixation system rod

Threshold V2 Pedicle Screw - M7405514530

Pedicle Screw
SPINEOLOGY INC.
10-10-80-82
Not in Commercial Distribution

  • M7405514530 ()

  • 30x4.5
  • Length: 30 Millimeter
551-4530

  • Bone-screw internal spinal fixation system rod

Threshold V2 Pedicle Screw - M7405514525

Pedicle Screw
SPINEOLOGY INC.
10-10-80-81
Not in Commercial Distribution

  • M7405514525 ()

  • 25x4.5
  • Length: 25 Millimeter
551-4525

  • Bone-screw internal spinal fixation system rod

Threshold V2 Pedicle Screw - M7405504550

Pedicle Screw
SPINEOLOGY INC.
10-10-78-42
In Commercial Distribution

  • M7405504550 ()

  • Length: 50 Millimeter
  • 50x4.5
550-4550

  • Spinal bone screw, non-bioabsorbable

Threshold V2 Pedicle Screw - M7405504545

Pedicle Screw
SPINEOLOGY INC.
10-10-78-41
In Commercial Distribution

  • M7405504545 ()

  • 45x4.5
  • Length: 45 Millimeter
550-4545

  • Spinal bone screw, non-bioabsorbable

Threshold V2 Pedicle Screw - M7405504540

Pedicle Screw
SPINEOLOGY INC.
10-10-78-40
In Commercial Distribution

  • M7405504540 ()

  • Length: 40 Millimeter
  • 40x4.5
550-4540

  • Spinal bone screw, non-bioabsorbable

Threshold V2 Pedicle Screw - M7405504535

Pedicle Screw
SPINEOLOGY INC.
10-10-78-39
In Commercial Distribution

  • M7405504535 ()

  • 35x4.5
  • Length: 35 Millimeter
550-4535

  • Spinal bone screw, non-bioabsorbable

Threshold V2 Pedicle Screw - M7405504530

Pedicle Screw
SPINEOLOGY INC.
10-10-78-38
In Commercial Distribution

  • M7405504530 ()

  • Length: 30 Millimeter
  • 30 x4.5
550-4530

  • Spinal bone screw, non-bioabsorbable

Threshold V2 Pedicle Screw - M7405504525

Pedicle Screw
SPINEOLOGY INC.
10-10-78-37
In Commercial Distribution

  • M7405504525 ()

  • 25x4.5
  • Length: 25 Millimeter
550-4525

  • Spinal bone screw, non-bioabsorbable

PATIENT PACK NSU V2 - M75257029021

HENRY SCHEIN DENTAL TRAINING FOR DENTAL SURGURY. THIS PACK CONTAINS PATIENT PPE USED IN SUPPORT OF ORAL SURGERY. HENRY SCHEIN PRODUCT FOR NSU.
STRADIS MEDICAL LLC
570-2902
In Commercial Distribution

  • M75257029021 ()
  • M75257029025 ()


  • General surgical procedure kit, non-medicated, single-use

Threshold V2 Reduction Screw - M7405717590

Reduction Screw
SPINEOLOGY INC.
10-10-80-99
In Commercial Distribution

  • M7405717590 ()

  • 100x7.5
  • Length: 100 Millimeter
571-7590

  • Spinal bone screw, non-bioabsorbable

Threshold V2 Reduction Screw - M7405717570

Reduction Screw
SPINEOLOGY INC.
10-10-80-97
In Commercial Distribution

  • M7405717570 ()

  • Length: 100 Millimeter
  • 100x7.5
571-7570

  • Spinal bone screw, non-bioabsorbable

Threshold V2 Reduction Screw - M7405704550

Reduction Screw
SPINEOLOGY INC.
10-10-83-31
In Commercial Distribution

  • M7405704550 ()

  • 50x4.5
  • Length: 50 Millimeter
570-4550

  • Spinal bone screw, non-bioabsorbable

Threshold V2 Reduction Screw - M7405704540

Reduction Screw
SPINEOLOGY INC.
10-10-83-29
In Commercial Distribution

  • M7405704540 ()

  • 40x4.5
  • Length: 40 Millimeter
570-4540

  • Spinal bone screw, non-bioabsorbable

Threshold V2 Reduction Screw - M7405717599

Reduction Screw
SPINEOLOGY INC.
10-10-80-100
In Commercial Distribution

  • M7405717599 ()

  • Length: 100 Millimeter
  • 100x7.5
571-7599

  • Spinal bone screw, non-bioabsorbable

Threshold V2 Reduction Screw - M7405717580

Reduction Screw
SPINEOLOGY INC.
10-10-80-98
In Commercial Distribution

  • M7405717580 ()

  • Length: 100 Millimeter
  • 100x7.5
571-7580

  • Spinal bone screw, non-bioabsorbable

Threshold V2 Reduction Screw - M7405707599

Reduction Screw
SPINEOLOGY INC.
10-10-84-19
In Commercial Distribution

  • M7405707599 ()

  • Length: 100 Millimeter
  • 100x7.5
570-7599

  • Spinal bone screw, non-bioabsorbable

Threshold V2 Reduction Screw - M7405707590

Reduction Screw
SPINEOLOGY INC.
10-10-84-18
In Commercial Distribution

  • M7405707590 ()

  • 90x7.5
  • Length: 90 Millimeter
570-7590

  • Spinal bone screw, non-bioabsorbable

Threshold V2 Reduction Screw - M7405707580

Reduction Screw
SPINEOLOGY INC.
10-10-84-17
In Commercial Distribution

  • M7405707580 ()

  • Length: 80 Millimeter
  • 80x7.5
570-7580

  • Spinal bone screw, non-bioabsorbable

Threshold V2 Reduction Screw - M7405707570

Reduction Screw
SPINEOLOGY INC.
10-10-84-16
In Commercial Distribution

  • M7405707570 ()

  • Length: 70 Millimeter
  • 70x7.5
570-7570

  • Spinal bone screw, non-bioabsorbable

Threshold V2 Reduction Screw - M7405704545

Reduction Screw
SPINEOLOGY INC.
10-10-83-30
In Commercial Distribution

  • M7405704545 ()

  • 45x4.5
  • Length: 45 Millimeter
570-4545

  • Spinal bone screw, non-bioabsorbable
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