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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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EXCELSIUSGPS - 00193982617479

Lateral Cobb, 10mm, FH, GPS
GLOBUS MEDICAL, INC.
6255.0010
In Commercial Distribution

  • 00193982617479 ()


  • Robotic surgical navigation system

ORTHOPEDIC MANUAL SURGICAL INSTRUMENT - 00193982617424

Slap Hammer
GLOBUS MEDICAL, INC.
6255.0001
In Commercial Distribution

  • 00193982617424 ()


  • Robotic surgical navigation system

ORTHOPEDIC MANUAL SURGICAL INSTRUMENT - 00193982616465

Straight Handle, IBF
GLOBUS MEDICAL, INC.
6255.0007
In Commercial Distribution

  • 00193982616465 ()


  • Robotic surgical navigation system

ORTHOPEDIC MANUAL SURGICAL INSTRUMENT - 00193982616458

T-Handle, IBF
GLOBUS MEDICAL, INC.
6255.0005
In Commercial Distribution

  • 00193982616458 ()


  • Robotic surgical navigation system

EXCELSIUSHUB - 00193982465155

Flat Panel Fluoroscopy Registration Fixture
GLOBUS MEDICAL, INC.
6203.2100
In Commercial Distribution

  • 00193982465155 ()


  • Robotic surgical navigation system

AESCULAP - 04046963067359

ORTHOPILOT DISPOS.PASSIVE MARKER STERILE
Aesculap AG
FS617
In Commercial Distribution

  • 04046963067359 ()
  • 04038653457304 ()
FS617

  • Robotic surgical navigation system

AESCULAP - 04046963188849

ORTHOPILOT FOOT SWITCH F/COMPACT & FLEX
Aesculap AG
FS007
Not in Commercial Distribution

  • 04046963188849 ()
FS007

  • Robotic surgical navigation system

AESCULAP - 04046963168933

ORTHOPILOT BASIS COMPACT
Aesculap AG
FS101
In Commercial Distribution

  • 04046963168933 ()
FS101

  • Robotic surgical navigation system

EXACTECHGPS - 10885862574091

STATION2+
Exactech, Inc.
I00025
In Commercial Distribution

  • 10885862574091 ()

  • V2
I00025

  • Robotic surgical navigation system

EXACTECHGPS - 10885862553331

MOBILE CART
Exactech, Inc.
J00120
In Commercial Distribution

  • 10885862553331 ()

  • V2
J00120

  • Robotic surgical navigation system

EXACTECHGPS - 10885862144294

IMPLANT KIT
Exactech, Inc.
A10007
In Commercial Distribution

  • 10885862144294 ()

  • V1
A10007

  • Robotic surgical navigation system

EXACTECHGPS - 10885862144287

TRACKER
Exactech, Inc.
A10005
In Commercial Distribution

  • 10885862144287 ()

  • T
A10005

  • Robotic surgical navigation system

EXACTECHGPS - 10885862144270

TRACKER
Exactech, Inc.
A10006
In Commercial Distribution

  • 10885862144270 ()

  • G
A10006

  • Robotic surgical navigation system

EXACTECHGPS - 10885862144263

TRACKER
Exactech, Inc.
A10004
In Commercial Distribution

  • 10885862144263 ()

  • F
A10004

  • Robotic surgical navigation system

EXACTECHGPS - 10885862144256

PROBE
Exactech, Inc.
A10003
In Commercial Distribution

  • 10885862144256 ()
A10003

  • Robotic surgical navigation system

EXACTECHGPS - 10885862144225

POWER CABLE
Exactech, Inc.
K00001
In Commercial Distribution

  • 10885862144225 ()
K00001

  • Robotic surgical navigation system

EXACTECHGPS - 10885862144218

MOUNTING ARM CLAMP
Exactech, Inc.
J00011
In Commercial Distribution

  • 10885862144218 ()
J00011

  • Robotic surgical navigation system

EXACTECHGPS - 10885862144195

MOUNTING ARM
Exactech, Inc.
J00010
In Commercial Distribution

  • 10885862144195 ()

  • LOWER
J00010

  • Robotic surgical navigation system

S-Series OCT - 00754016215049

The OTIS 2.1 Optical Coherence Tomography System is indicated for use as an imaging tool in the evaluation of excised human tissue microstructure by providing two-dimensional, cross-sectional, real-time depth visualization, with image review manipulation software for identifying and annotating regions of interest. Perimeter’s OTIS 2.1 cart assembly encloses an OCT-based imaging system and has a touchscreen monitor.
Perimeter Medical Imaging AI, Inc.
PMI001OCT21
In Commercial Distribution

  • 00754016215049 ()
  • 10754016215046 ()
ASY-2000

  • Dermatological optical coherence tomography system

Specimen Immobilizer - 00754016215025

The OTIS 2.1 system includes a single-use specimen container, the Consumable Set, that facilitates tissue imaging. The consumable set consists of a Specimen Tray and Specimen Lid. The Specimen Tray engages with the device to initiate scanning and the Specimen Lid facilitates engaging vacuum to enable vacuum assisted specimen positioning during image acquisition.
Perimeter Medical Imaging AI, Inc.
PMI010CON21
In Commercial Distribution

  • 20754016215029 ()
  • 00754016215025 ()
  • 00754016215032 ()
ASY-2600

  • Dermatological optical coherence tomography system

THiA - 00754016215018

The OTIS 2.1 Optical Coherence Tomography System is indicated for use as an imaging tool in the evaluation of excised human tissue microstructure by providing two-dimensional, cross-sectional, real-time depth visualization, with image review manipulation software for identifying and annotating regions of interest. Perimeter’s OTIS 2.1 cart assembly encloses an OCT-based imaging system and has a touchscreen monitor.
Perimeter Medical Imaging AI, Inc.
PMI001OCT21
In Commercial Distribution

  • 00754016215018 ()
  • 10754016215015 ()
ASY-2000

  • Dermatological optical coherence tomography system

Clearlens - 00885556805442

CLEARLENS TRACKING ARRAY SET KNEE(16PCS)
Smith & Nephew, Inc.
53245
In Commercial Distribution

  • 00885556805442 ()
53245

  • Robotic surgical navigation system

Clearlens - 00885556805008

CLEARLENS TRACKING ARRAY SET KNEE
Smith & Nephew, Inc.
53236
In Commercial Distribution

  • 00885556805008 ()
53236

  • Robotic surgical navigation system

Sesamoid Plasty V2 HDMI Cable 30' - 00889024488502

No Description
Orthosoft Inc
20-8000-071-24
Not in Commercial Distribution

  • 00889024488502 ()

  • Length: 30 Feet


  • Robotic surgical navigation system

ClearLens ® Pointer Gauge – Knee - 04056481141783

No Description
Brainlab AG
53237-10
Not in Commercial Distribution

  • 04056481141783 ()


  • Robotic surgical navigation system

Knee Plane Tool-Bone Verification Plate Partial - 04056481138912

No Description
Brainlab AG
53205
Not in Commercial Distribution

  • 04056481138912 ()
53205

  • Robotic surgical navigation system

ClearLens Knee Plane Tool - 04056481138738

No Description
Brainlab AG
53238A
Not in Commercial Distribution

  • 04056481138738 ()
53238A

  • Robotic surgical navigation system

ClearLens Pointer Handle - Knee - 04056481138721

No Description
Brainlab AG
53237A
Not in Commercial Distribution

  • 04056481138721 ()
53237A

  • Robotic surgical navigation system

Stem Verif. Tool Ref. Array - 04056481006198

No Description
Brainlab AG
41836
Not in Commercial Distribution

  • 04056481006198 ()
41836

  • Robotic surgical navigation system

Bl Pointer Knee Straight - 04056481005771

No Description
Brainlab AG
52782
Not in Commercial Distribution

  • 04056481005771 ()
52782

  • Robotic surgical navigation system

Stem Verif. Tool Extended Ref.Array - 04056481005719

No Description
Brainlab AG
52866
Not in Commercial Distribution

  • 04056481005719 ()
52866

  • Robotic surgical navigation system

Knee Plane Tool - Array - 04056481005627

No Description
Brainlab AG
53201
Not in Commercial Distribution

  • 04056481005627 ()
53201

  • Robotic surgical navigation system

Knee Plane Tool - Cb Adapter - 04056481005610

No Description
Brainlab AG
53202
Not in Commercial Distribution

  • 04056481005610 ()
53202

  • Robotic surgical navigation system

Knee Plane Tool - Bone Plate - 04056481005603

No Description
Brainlab AG
53203
Not in Commercial Distribution

  • 04056481005603 ()
53203

  • Robotic surgical navigation system

Knee Plane Tool-Bone Verification Plate - 04056481005597

No Description
Brainlab AG
53204
Not in Commercial Distribution

  • 04056481005597 ()
53204

  • Robotic surgical navigation system

Instrument Adapter, Starlock V2012 - 04056481005368

No Description
Brainlab AG
55085
Not in Commercial Distribution

  • 04056481005368 ()
55085

  • Robotic surgical navigation system

Cup Reamer Adapter ''Precimed Ez-Clean'' - 04056481002671

No Description
Brainlab AG
41879-03
Not in Commercial Distribution

  • 04056481002671 ()
41879-03

  • Robotic surgical navigation system

Pinless Femur Reference Array - 04056481002411

No Description
Brainlab AG
52400-01A
Not in Commercial Distribution

  • 04056481002411 ()
52400-01A

  • Robotic surgical navigation system

Gauge Bl Pointer Straight-Extended - 04056481002169

No Description
Brainlab AG
52781-10
Not in Commercial Distribution

  • 04056481002169 ()
52781-10

  • Robotic surgical navigation system

Gauge Bl Pointer Knee Straight - 04056481002145

No Description
Brainlab AG
52782-10
Not in Commercial Distribution

  • 04056481002145 ()
52782-10

  • Robotic surgical navigation system
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