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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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Tools - 07290107274739

Ratchet Hex Driver for Implant
A.B. DENTAL DEVICES LTD
T3-2,9
In Commercial Distribution

  • 17290107274736 ()
  • 07290107274739 ()
T3-2,9

  • Surgical screwdriver, reusable

Tools - 07290107274722

Hand Hex Driver for P6
A.B. DENTAL DEVICES LTD
T2-1.8,15
In Commercial Distribution

  • 17290107274729 ()
  • 07290107274722 ()
T2-1.8,15

  • Surgical screwdriver, reusable

Tools - 07290107274685

Ratchet Hex Driver for P6
A.B. DENTAL DEVICES LTD
T1-1.8,15
In Commercial Distribution

  • 17290107274682 ()
  • 07290107274685 ()
T1-1.8,15

  • Surgical screwdriver, reusable

Tools - 07290107274678

Ratchet Hex Driver for P6
A.B. DENTAL DEVICES LTD
T1-1.8,9
In Commercial Distribution

  • 17290107274675 ()
  • 07290107274678 ()
T1-1.8,9

  • Surgical screwdriver, reusable

Tools - 07290107274661

Ratchet Hex Driver for Abutment, 1.25 mm Diameter, 15 mm length
A.B. DENTAL DEVICES LTD
T1-1.2,15
In Commercial Distribution

  • 07290107274661 ()
  • 17290107274705 ()
T1-1.2,15

  • Surgical screwdriver, reusable

Tools - 07290107274654

Ratchet Hex Driver for Abutment, 1.25 mm Diameter, 9 mm length
A.B. DENTAL DEVICES LTD
T1-1.2,9
In Commercial Distribution

  • 07290107274654 ()
T1-1.2,9

  • Surgical screwdriver, reusable

Tools - 07290107274258

Analog for P24
A.B. DENTAL DEVICES LTD
D1-P24
In Commercial Distribution

  • 17290107274255 ()
  • 07290107274258 ()
D1-P24

  • Dental implant analog

OrthoGrid Hip Preservation - 00860003424810

OrthoGrid Hip Preservation 3.0 non-invasive software system that provides image analysis tools for Hip Preservation.
Orthogrid Systems, Inc.
4015-915-501
In Commercial Distribution

  • 00860003424810 ()


  • Orthopaedic fluoroscopic grid software

My Dose Coach - 04030685900018

Insulin Titration App
Sanofi-Aventis Deutschland GmbH
2.x.x
Not in Commercial Distribution


  • No size - Software as a Medical Device
N/A

  • Clinical management support software

OrthoGrid Hip AI - 00860003424834

OrthoGrid Hip AI for non-invasive software system that provides image analysis tools for Total Hip Replacement
Orthogrid Systems, Inc.
1015-915-505
In Commercial Distribution

  • 00860003424834 ()


  • Orthopaedic fluoroscopic grid software

OrthoGrid Hip - 00860003424803

OrthoGrid Hip 3.0 for non-invasive software system that provides image analysis tools for Total Hip Replacement
Orthogrid Systems, Inc.
1015-915-504
In Commercial Distribution

  • 00860003424803 ()


  • Orthopaedic fluoroscopic grid software

T.O.V.A. - 00862290000326

The Test of Variables of Attention (T.O.V.A.) software is a computerized assessment of attention and inhibitory control that runs on most Windows and Mac-based computers. The T.O.V.A. provides healthcare professionals with objective measurements of attention and inhibitory control. The visual T.O.V.A. aids in the assessment of, and evaluation of treatment for, attention deficits, including attention-deficit/hyperactivity disorder (ADHD). The auditory T.O.V.A. aids in the assessment of attention deficits, including ADHD. T.O.V.A. results should only be interpreted by qualified professionals.
TOVA COMPANY, THE
Software
In Commercial Distribution

  • 00862290000326 ()


  • Cognitive assessment software

VT1 - 03760253450577

No Description
FIM MEDICAL
Software
In Commercial Distribution

  • 03760253450577 ()


  • Pulmonary function analysis system, adult

VT1 - 03760253450157

No Description
FIM MEDICAL
Software
Not in Commercial Distribution

  • 03760253450157 ()


  • Pulmonary function analysis system, adult

NA - 10887587058801

SUPPORT FOR CUTTING TOOLS
Synthes GmbH
68.000.007.98
In Commercial Distribution

  • 10886982251343 ()
  • 10887587058801 ()
  • H98068000007980 ()
6800000798

  • Surgical instrument/implant rack

LINX - 00855106005219

LINX Esophagus Sizing Tools
Torax Medical, Inc.
LSSUS
In Commercial Distribution

  • 00855106005219 ()
  • 00855106005226 ()
LSSUS

  • Gastro-oesophageal antireflux prosthesis

Tsolution One Surgical System - M9461029400

ASSEMBLY, INSTALLATION VERIFICATION TOOLS
THINK SURGICAL, INC.
102940
In Commercial Distribution

  • M9461029400 ()


  • Robotic surgical arm system

Thoratec® HeartMate 3™ Surgical Hand Tools - 00813024013259

HM3 Surgical Hand Tools
Thoratec Corporation
10002222US
In Commercial Distribution

  • 00813024013259 ()
10002222US

  • Cardiothoracic surgical procedure kit, non-medicated, reusable

NA - 10681490078013

ACCESSORY 3550-06 TUNNELING TOOLS
MEDTRONIC, INC.
3550-06
Not in Commercial Distribution

  • 10681490078013 ()


  • Subcutaneous tunneller, single-use

DTI IMPLANT SISTEMLERI - 08680671496399

REMOVAL TOOLS ULTRA MINI
DTI IMPLANT SISTEMLERI SANAYI TICARET ANONIM SIRKETI
SURGICAL KIT
In Commercial Distribution

  • 08680671496399 ()
DTIDRTOUM

  • Surgical screwdriver, reusable

Aero-Med - 10810010890501

ThinPrep Collection Tools; Combo
AERO-MED, LLC
BRL205
In Commercial Distribution

  • 50810010890509 ()
  • 10810010890501 ()
BRL205

  • Papanicolaou smear kit

Aero-Med - 10810010890495

ThinPrep Collection Tools; Broom
AERO-MED, LLC
BRL190
In Commercial Distribution

  • 50810010890493 ()
  • 10810010890495 ()
BRL190

  • Cervical cytology brush

Aero-Med - 10810010890471

SurePath Collection Tools; Combo
AERO-MED, LLC
BRL165
In Commercial Distribution

  • 50810010890479 ()
  • 10810010890471 ()
BRL165

  • Papanicolaou smear kit

Aero-Med - 10810010890464

SurePath Collection Tools; Broom
AERO-MED, LLC
BRL150
In Commercial Distribution

  • 50810010890462 ()
  • 10810010890464 ()
BRL150

  • Cervical cytology brush

CARDINAL HEALTH - 50810010891599

Kit; Heartsmart Replacement Tools
Cardinal Health 200, LLC
AMM306
In Commercial Distribution

  • 50810010891599 ()
AMM306

  • Phlebotomy kit

MIS - 07290109006420

Mountless delivery tools set
MIS Implants Technologies Ltd.
MK-0037
Not in Commercial Distribution

  • 07290109006420 ()
MK-0037

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable

CARDINAL HEALTH - 20885380096744

Cardinal Health; Crypto Giardia Control; Contains (1) 1.0mL Cryptosporidium + and (1) 1.0mL Giardia +; IVD
Cardinal Health 200, LLC
CH6870
In Commercial Distribution

  • 50885380096745 ()
  • 20885380096744 ()
  • 10885380096747 ()
CH6870

  • Multiple faecal parasite antigen IVD, kit, rapid ICT, clinical

CosmoLock Pedicle Screw System - B07311K0730060

Rod Bender, 5.5 mm, 5 Position
Kalitec Direct LLC
11-K07-3006
In Commercial Distribution

  • B07311K0730060 ()


  • Spinal rod bending system

CosmoLock Pedicle Screw System - B07311K0330160

Coronal Bender, Right
Kalitec Direct LLC
11-K03-3016
In Commercial Distribution

  • B07311K0330160 ()


  • Spinal rod bending system

CosmoLock Pedicle Screw System - B07311K0330150

Coronal Bender, Left
Kalitec Direct LLC
11-K03-3015
In Commercial Distribution

  • B07311K0330150 ()


  • Spinal rod bending system

CosmoLock Pedicle Screw System - B07311K0330060

Rod Bender, 5.5 mm, 3 Position
Kalitec Direct LLC
11-K03-3006
In Commercial Distribution

  • B07311K0330060 ()


  • Spinal rod bending system

CosmoLock Pedicle Screw System - B07311K0150030

Bender, Fixed Cross Link, Right
Kalitec Direct LLC
11-K01-5003
In Commercial Distribution

  • B07311K0150030 ()


  • Spinal rod bending system

CosmoLock Pedicle Screw System - B07311K0150020

Bender, Fixed Cross Link, Left
Kalitec Direct LLC
11-K01-5002
In Commercial Distribution

  • B07311K0150020 ()


  • Spinal rod bending system

Cosmolock Pedicle Screw System - B07311K0130190

T-Handle, Head Persuader, 5.5mm
Kalitec Direct LLC
11-K01-3019
In Commercial Distribution

  • B07311K0130190 ()


  • Spinal rod bending system

CosmoLock Pedicle Screw System - B07311K0130140

Sagittal Bender, Right
Kalitec Direct LLC
11-K01-3014
In Commercial Distribution

  • B07311K0130140 ()


  • Spinal rod bending system

CosmoLock Pedicle Screw System - B07311K0130130

Sagittal Bender, Left
Kalitec Direct LLC
11-K01-3013
In Commercial Distribution

  • B07311K0130130 ()


  • Spinal rod bending system

NIDO Pedicle Screw System - B07315K0430210

Sagittal Bender, Double Ended Right
Kalitec Direct LLC
15-K04-3021
In Commercial Distribution

  • B07315K0430210 ()
15-K04-3021

  • Spinal rod bending system

NIDO Pedicle Screw System - B07315K0430200

Sagittal Bender, Double Ended Left
Kalitec Direct LLC
15-K04-3020
In Commercial Distribution

  • B07315K0430200 ()
15-K04-3020

  • Spinal rod bending system

NIDO Pedicle Screw System - B07315K0122100

T-Handle, Head Persuader
Kalitec Direct LLC
15-K01-2210
In Commercial Distribution

  • B07315K0122100 ()
15-K01-2210

  • Spinal rod bending system

Black Diamond Pedicle Screw System - B06210101400

IN-SITU BENDERS, BLK DIAMOND
Osseus Fusion Systems, LLC
1010-1400
In Commercial Distribution

  • B06210101400 ()
1010-1400

  • Spinal rod bending system

Black Diamond Pedicle Screw System - B06210101017

ROD BENDER, BLK DIAMOND
Osseus Fusion Systems, LLC
1010-1017
In Commercial Distribution

  • B06210101017 ()
1010-1017

  • Spinal rod bending system

Black Diamond Pedicle Screw System - B06210101550

TUBE ROD BENDER, BLK DIAMOND
Osseus Fusion Systems, LLC
1010-1550
In Commercial Distribution

  • B06210101550 ()
1010-1550

  • Spinal rod bending system

Invictus - 00190376394428

Fixed Screwdriver, Navigation
ALPHATEC SPINE, INC.
17060-N
In Commercial Distribution

  • 00190376394428 ()


  • Spinal rod bending system

Neo ADVISE - 07649994217013

No Description
Comerge AG
R2.X.Y
In Commercial Distribution

  • 07649994217013 ()


  • Spinal rod bending system

NuVaMap - 00887517707291

NuVaMap O.R. C-Arm Image Converter
Nuvasive, Inc.
8210348
In Commercial Distribution

  • 00887517707291 ()


  • Spinal rod bending system

NuVaMap - 00887517695505

NuVaMap O.R. Calibration Sphere
Nuvasive, Inc.
8210347
In Commercial Distribution

  • 00887517695505 ()


  • Spinal rod bending system

ReLine - 00887517757142

RELINE Trauma Pointer, Bendini
Nuvasive, Inc.
10001049
In Commercial Distribution

  • 00887517757142 ()


  • Spinal rod bending system

Bendini - 00887517728203

Bendini Template, Rod Hinged
Nuvasive, Inc.
8210322
In Commercial Distribution

  • 00887517728203 ()


  • Spinal rod bending system

Bendini - 00887517141132

Bendini IR Probe Passive Sphere, 5 Pack
Nuvasive, Inc.
1578787
In Commercial Distribution

  • 00887517141132 ()


  • Spinal rod bending system

Bendini - 00887517193957

Bendini Rod Bender II, Spinal
Nuvasive, Inc.
8210306
In Commercial Distribution

  • 00887517193957 ()


  • Spinal rod bending system
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