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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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Omnia Medical PsiF - 00843511100919

PsiF Slap Hammer
OMNIA MEDICAL, LLC
01-01-0011
In Commercial Distribution

  • 00843511100919 ()
01-01-0011

  • Surgical mallet

Omnia Medical PsiF - 00843511100896

PsiF Twist Drill
OMNIA MEDICAL, LLC
01-01-0004
In Commercial Distribution

  • 00843511100896 ()
01-01-0004

  • Surgical screwdriver, reusable

Omnia Medical PsiF - 00843511100889

PsiF Mallet Instrument
OMNIA MEDICAL, LLC
01-5P-MAL1
In Commercial Distribution

  • 00843511100889 ()
01-5P-MAL1

  • Surgical mallet

Pedicle Screw - 00843511100728

Pedicle Screw Removal Tool
OMNIA MEDICAL, LLC
19-6A-PSRT
In Commercial Distribution

  • 00843511100728 ()
19-6A-PSRT

  • Surgical screwdriver, reusable

Omnia Medical PsiF - 00843511100681

PsiF Impaction Cap Ball Handle
OMNIA MEDICAL, LLC
01-5P-IBH1
In Commercial Distribution

  • 00843511100681 ()
01-5P-IBH1

  • Surgical mallet

Omnia Medical VBR - 00843511100452

Omnia Medical VBR, Mallet
OMNIA MEDICAL, LLC
06-6V-MAL1
In Commercial Distribution

  • 00843511100452 ()
06-6V-MAL1

  • Surgical mallet

Juveno™ Femoral Hip System - 00843575102690

MALLET
B-ONE ORTHO, CORP.
8819022000
In Commercial Distribution

  • 00843575102690 ()
8819022000

  • Surgical mallet

Omnia Medical Instruments - 00843511123222

3.0 mm HEX DRIVER
OMNIA MEDICAL, LLC
99-5P-HD30
In Commercial Distribution

  • 00843511123222 ()


  • Surgical screwdriver, reusable

Omnia Medical Instruments - 00843511122829

Drill Bit
OMNIA MEDICAL, LLC
99-5U-STDB
In Commercial Distribution

  • 00843511122829 ()


  • Surgical screwdriver, reusable

Omnia Medical Instruments - 00843511122713

4.0 mm HEX DRIVER
OMNIA MEDICAL, LLC
99-5P-HD40
In Commercial Distribution

  • 00843511122713 ()


  • Surgical screwdriver, reusable

Omnia Medical Instruments - 00843511122690

2.5 mm HEX DRIVER
OMNIA MEDICAL, LLC
99-5P-HD25
In Commercial Distribution

  • 00843511122690 ()


  • Surgical screwdriver, reusable

Omnia Medical PsiF - 00843511121266

Impaction Cap Handle
OMNIA MEDICAL, LLC
01-5P-ICH2
In Commercial Distribution

  • 00843511121266 ()
01-5P-ICH2

  • Surgical mallet

Omnia Medical Coupler-C - 00843511113612

CERVICAL TAPERED SCREWDRIVER
OMNIA MEDICAL, LLC
15-5C-DRV1
In Commercial Distribution

  • 00843511113612 ()
15-5C-DRV1

  • Surgical screwdriver, reusable

Omnia Medical Coupler-C - 00843511113599

CERVICAL CAM DRIVER
OMNIA MEDICAL, LLC
15-5C-DRV2
In Commercial Distribution

  • 00843511113599 ()
15-5C-DRV2

  • Surgical screwdriver, reusable

TiBrid-SA - 00843511113100

Screwdriver, Tapered, T20 TiN
OMNIA MEDICAL, LLC
17-5A-DRV5
In Commercial Distribution

  • 00843511113100 ()


  • Surgical screwdriver, reusable

TiBrid-SA - 00843511113094

Screwdriver, Straight, T15
OMNIA MEDICAL, LLC
17-5A-DRV4
In Commercial Distribution

  • 00843511113094 ()


  • Surgical screwdriver, reusable

TiBrid-SA - 00843511113087

Screwdriver, Flex, Tapered, T20
OMNIA MEDICAL, LLC
17-5A-DRV3
In Commercial Distribution

  • 00843511113087 ()


  • Surgical screwdriver, reusable

TiBrid-SA - 00843511113070

Screwdriver, Tapered, T20
OMNIA MEDICAL, LLC
17-5A-DRV2
In Commercial Distribution

  • 00843511113070 ()


  • Surgical screwdriver, reusable

TiBrid-SA - 00843511113063

Screwdriver, Straight, T20
OMNIA MEDICAL, LLC
17-5A-DRV1
In Commercial Distribution

  • 00843511113063 ()


  • Surgical screwdriver, reusable

Omnia Medical Instruments - 00843511112943

PsiF Mallet with Joint Finder Feature
OMNIA MEDICAL, LLC
22-5P-MAL4
In Commercial Distribution

  • 00843511112943 ()


  • Surgical mallet

SIC invent Dental Implant Systems - 04260516874168

SIC TR Screwdriver, short, hex. 1.2 mm
SIC invent AG
937128
In Commercial Distribution

  • 04260516874168 ()


  • Surgical screwdriver, reusable

SIC invent Dental Implant Systems - 04260516873901

SIC Screwdriver, Angle Piece, long, hex. 1.2 mm
SIC invent AG
937031
In Commercial Distribution

  • 04260516873901 ()


  • Surgical screwdriver, reusable

EIT PLIF Hammer - 04260397088081

Slap-Hammer
EIT Emerging Implant Technologies GmbH
PET60251
In Commercial Distribution

  • 04260397088081 ()


  • Surgical mallet

Medical Screwdriver (SD 2) - 09008737527907

Single-Use Surgical Tool
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
52790
In Commercial Distribution

  • 09008737527907 ()


  • Surgical screwdriver, single-use

Surgical Screwdriver (SD 2) - 09008737522605

Single-Use Surgical Tool
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
52260
Not in Commercial Distribution

  • 09008737522605 ()


  • Surgical screwdriver, single-use

EIT PLIF Hammer - 04260397080849

Hammer
EIT Emerging Implant Technologies GmbH
PET60250
In Commercial Distribution

  • 04260397080849 ()


  • Surgical mallet

N/A - 00613994538222

COUNTER TORQUE 8350395 STANDARD
MEDTRONIC SOFAMOR DANEK, INC.
8350395
In Commercial Distribution

  • 00613994538222 ()


  • Surgical screwdriver, reusable

N/A - 00613994538215

DRIVER 8350392 T HAND SCREW ADJUSTMENT
MEDTRONIC SOFAMOR DANEK, INC.
8350392
In Commercial Distribution

  • 00613994538215 ()


  • Orthopaedic implant driver

N/A - 00613994526502

DRIVER X0605043 3.5MM CAPTIVE TWIST HEX
MEDTRONIC SOFAMOR DANEK, INC.
X0605043
In Commercial Distribution

  • 00613994526502 ()

  • 3.5mm


  • Surgical screwdriver, reusable

N/A - 00613994516282

SCREWDRIVER X0808199 CMAS SHORT
MEDTRONIC SOFAMOR DANEK, INC.
X0808199
In Commercial Distribution

  • 00613994516282 ()


  • Surgical screwdriver, reusable
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