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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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Vac-Lok™ Cushion - 00841439108260

Reusable, non-sterile, 75 x 105cm, 28L, nylon bag with indexing for arms-up positioning safe for use in 1.5T and 3.0T MR environments
MEDTEC, INC.
MTVLARM02FC
Not in Commercial Distribution

  • 00841439108260 ()
MTVLARM02FC

  • Vacuum-mould patient positioning system

Vac-Lok Cushion - 00841439108253

Reusable, non-sterile, 75 x 105cm, 28L, nylon bag for arms-up positioning safe for use in 1.5T and 3.0T MR environments
MEDTEC, INC.
MTVLARM02C
Not in Commercial Distribution

  • 00841439108253 ()

  • Length: 75 Centimeter
MTVLARM02C

  • Vacuum-mould patient positioning system

Vac-Lok™ Cushion - 00841439108246

Reusable, non-sterile, 75 x 105cm, 28L, clear urethane bag for arms-up positioning safe for use in 1.5T and 3.0T MR environments
MEDTEC, INC.
MTVLARM02
Not in Commercial Distribution

  • 00841439108246 ()
MTVLARM02

  • Vacuum-mould patient positioning system

Vac-Lok™ Cushion - 00841439108239

Reusable, non-sterile, 75 x 75cm, 20L, nylon bag with indexing for arms-up positioning safe for use in 1.5T and 3.0T MR environments
MEDTEC, INC.
MTVLARM01FC
Not in Commercial Distribution

  • 00841439108239 ()
MTVLARM01FC

  • Vacuum-mould patient positioning system

Vac-Lok Cushion - 00841439108222

Reusable, non-sterile, 75 x 75cm, 20L, nylon bag for arms-up positioning safe for use in 1.5T and 3.0T MR environments
MEDTEC, INC.
MTVLARM01C
Not in Commercial Distribution

  • 00841439108222 ()

  • Length: 75 Centimeter
MTVLARM01C

  • Vacuum-mould patient positioning system

Vac-Lok™ Cushion - 00841439108215

Reusable, non-sterile, 75 x 75cm, 20L, clear urethane bag for arms-up positioning safe for use in 1.5T and 3.0T MR environments
MEDTEC, INC.
MTVLARM01
Not in Commercial Distribution

  • 00841439108215 ()
MTVLARM01

  • Vacuum-mould patient positioning system

Vac-Lok Cushion - 00841439108208

Reusable, non-sterile, 100 x 150cm, 80L, nylon bag safe for use in 1.5T and 3.0T MR environments
MEDTEC, INC.
MTVLA80C
Not in Commercial Distribution

  • 00841439108208 ()

  • Length: 150 Centimeter
MTVLA80C

  • Vacuum-mould patient positioning system

Vac-Lok™ Cushion - 00841439108192

60 x 100.5cm, 15L, nylon bag with indexing for pelvic positioning
MEDTEC, INC.
MTVL71FC
Not in Commercial Distribution

  • 00841439108192 ()
MTVL71FC

  • Vacuum-mould patient positioning system

Vac-Lok™ Cushion - 00841439108185

50 x 70cm, 6L, "T" shaped clear urethane bag
MEDTEC, INC.
MTVL37
Not in Commercial Distribution

  • 00841439108185 ()
MTVL37

  • Vacuum-mould patient positioning system

Vac-Lok™ Cushion - 00841439108154

87.5 x 140cm, 25L, "T" shaped nylon bag with indexing
MEDTEC, INC.
MTVL14FC25
Not in Commercial Distribution

  • 00841439108154 ()
MTVL14FC25

  • Vacuum-mould patient positioning system

Vac-Lok™ Cushion - 00841439108147

87.5 x 140cm, 25L "T" shaped nylon bag
MEDTEC, INC.
MTVL14C25
Not in Commercial Distribution

  • 00841439108147 ()
MTVL14C25

  • Vacuum-mould patient positioning system

DURAY - 00990010301290

DC1, Duray Scanner DC1 Package
Beyes Dental Canada Inc
DC1001
In Commercial Distribution

  • 00990010301290 ()
DC1

  • Dental computed radiography digital imaging scanner

ImagingRing - 19120075320037

No Description
medPhoton GmbH
1.2
In Commercial Distribution

  • 19120075320037 ()


  • Computed radiography digital imaging scanner

ImagingRing - 19120075320013

No Description
medPhoton GmbH
1.1
In Commercial Distribution

  • 19120075320013 ()


  • Computed radiography digital imaging scanner

CS 7400 - 40889978427969

CR SEMI-FIN PLATE PAN 15X30CM
CARESTREAM HEALTH, INC.
CS 7400
In Commercial Distribution

  • 60889978427963 ()
  • 40889978427969 ()
8427965

  • Dental computed radiography digital imaging scanner

CS 7400 - 40889978666948

CR SEMI-FIN PLATE PAN 5X12IN
CARESTREAM HEALTH, INC.
CS 7400
In Commercial Distribution

  • 60889978666942 ()
  • 40889978666948 ()
8666943

  • Dental computed radiography digital imaging scanner

CS 7400 - 40889978214231

CR SEMI-FIN PLATE PAN V2 5X12IN
CARESTREAM HEALTH, INC.
CS 7400
In Commercial Distribution

  • 60889978214235 ()
  • 40889978214231 ()
8214231

  • Dental computed radiography digital imaging scanner

NA - 00810050243056

Manual Wonder Pump
DOMICO MED-DEVICE, LLC
27625
In Commercial Distribution

  • 00810050243056 ()


  • Vacuum-mould patient positioning system

CS 7400 - 40889971337227

CR SEMI-FIN PLATE PAN V2 15X30CM
CARESTREAM HEALTH, INC.
CS 7400
In Commercial Distribution

  • 60889971337221 ()
  • 40889971337227 ()
1337229

  • Dental computed radiography digital imaging scanner

CS 7200 - 40889971067513

Hygienic Sheaths #2 - 200 Pcs
CARESTREAM HEALTH, INC.
CS 7200
In Commercial Distribution

  • 60889971067517 ()
  • 40889971067513 ()
  • 00889971067515 ()
1067511

  • Dental computed radiography digital imaging scanner

CS 7200 - 40889971067506

Hygienic Sheaths #1 - 200 Pcs
CARESTREAM HEALTH, INC.
CS 7200
In Commercial Distribution

  • 60889971067500 ()
  • 40889971067506 ()
  • 00889971067508 ()
1067503

  • Dental computed radiography digital imaging scanner

Nical Smart Micro - 08056600521355

No Description
NICAL SPA
NPR System
In Commercial Distribution

  • 08056600521355 ()
NPR1000VE

  • Dental computed radiography digital imaging scanner

Nical Smart Micro - 08056600521331

No Description
NICAL SPA
NPR System
In Commercial Distribution

  • 08056600521331 ()
NSM1001AA

  • Dental computed radiography digital imaging scanner

Nical Flat Panel - 08056600520044

No Description
NICAL SPA
NFP Digital detector
In Commercial Distribution

  • 08056600520044 ()
NF3024C00

  • Computed radiography digital imaging scanner

Nical Smart Micro - 08056600520020

No Description
NICAL SPA
NPR System
In Commercial Distribution

  • 08056600520020 ()
NSM1002EU

  • Dental computed radiography digital imaging scanner

Nical Smart Micro - 08056600520006

No Description
NICAL SPA
NPR System
In Commercial Distribution

  • 08056600520006 ()
NSM1001EU

  • Dental computed radiography digital imaging scanner

ACTEON - M430S70200111

"The PSPIX system is a laser X-ray device designed to digitize, display and erase intra oral x-ray images stored in imaging plates (IPs) - also known as phosphor plates."
SOPRO
SYSTEME PSPIX WIN MAC
In Commercial Distribution

  • M430S70200111 ()
S_702_0011

  • Dental computed radiography digital imaging scanner

Vac-Lok™ Cushion - 00841439112342

Nylon bag (100 x 200cm, 120L)
MEDTEC, INC.
VLH120C
Not in Commercial Distribution

  • 00841439112342 ()
VLH120C

  • Vacuum-mould patient positioning system

Vac-Lok Cushion - 00841439108178

Prone Vac-lok Cushion .5l
MEDTEC, INC.
MTVL27B
Not in Commercial Distribution

  • 00841439108178 ()

  • Length: 260 Centimeter
MTVL27B

  • Vacuum-mould patient positioning system

KLARITY MEDICAL - 00817355029842

Klarity Vacuum Bag 100cm x 70cm, 17.5 liter fill, with Civco-style valve
Klarity Medical Products, LLC
R7504-17.5C
In Commercial Distribution

  • 00817355029842 ()


  • Vacuum-mould patient positioning system

CONDOR - 00885554015225

CONDOR-STERIS ACT 3085 TABLE INTFC KIT
Smith & Nephew, Inc.
72201146
Not in Commercial Distribution

  • 00885554015225 ()
72201146

  • Operating room audiovisual data/device management system

CONDOR - 00885554014389

KIT CONDOR MED INTL
Smith & Nephew, Inc.
72201068
Not in Commercial Distribution

  • 00885554014389 ()
72201068

  • Operating room audiovisual data/device management system

NA - 00885554014228

CNDR TPI-P ANNOTATION GA MED
Smith & Nephew, Inc.
72201497
Not in Commercial Distribution

  • 00885554014228 ()
72201497

  • Operating room audiovisual data/device management system

CONDOR - 00885554013320

CONDOR-STERIS ACT LIGHT INTERFACE KIT
Smith & Nephew, Inc.
72201147
Not in Commercial Distribution

  • 00885554013320 ()
72201147

  • Operating room audiovisual data/device management system

CONDOR - 00885554012101

TPI-P ANNOTATION ASSY CONDOR MED
Smith & Nephew, Inc.
72200047
Not in Commercial Distribution

  • 00885554012101 ()
72200047

  • Operating room audiovisual data/device management system

CONDOR - 00885554011579

TPI-S ANALOG ASSY CONDOR MED
Smith & Nephew, Inc.
72200043
Not in Commercial Distribution

  • 00885554011579 ()
72200043

  • Operating room audiovisual data/device management system

AincA® - B005001960

Manometer, Wall Mount Swivel Mount, w/Arm (4.5"x180° Rot.) w/Hardware, fits all 00-199, 00-274 Gauges
ANESTHESIA ASSOCIATES, INC.
00-196
In Commercial Distribution

  • B005001960 ()
00-196

  • Airway pressure monitor, non-powered

Matrx Kidabra-Vi Drop Base (Cushion) - 07540147000769

Matrx Kidabra-Vi Drop Base. (Paediatric Skin Protection & Positioning Cushion). Includes hardware. Weight capacity up to 150 lbs
Motion Concepts Inc
KB-Vi
In Commercial Distribution

  • 07540147000769 ()
KBwwdd-Vi

  • Foam-filled chair cushion

Paradigm - 00850042604014

Paradigm System Cart, 120-volt
Proprio, Inc.
1100006
In Commercial Distribution

  • 00850042604014 ()
1100006

  • Optical surgical navigation device tracking system
  • Surgical planning/navigation-enhancement system
  • Stereotactic system application software

Paradigm - 00850042604007

Paradigm System Cart
Proprio, Inc.
1100001
Not in Commercial Distribution

  • 00850042604007 ()
  • 10850042604004 ()
1100003

  • Optical surgical navigation device tracking system
  • Surgical planning/navigation-enhancement system
  • Stereotactic system application software

AincA® - B005002000

Manometer, Pole Mount Clamp, for 1/4" to 1" dia Pole, w/Hardware, fits all 00-199, 00-274 Gauges
ANESTHESIA ASSOCIATES, INC.
00-200
In Commercial Distribution

  • B005002000 ()
00-200

  • Airway pressure monitor, non-powered

RescueNet ePCR - 00847946021900

Stand alone software used to collect, store and print patient data on a variety of commercial OTS hardware.
Zoll Medical Corporation
TMUL
In Commercial Distribution

  • 00847946021900 ()


  • Medical equipment clinical data interfacing software

Individual (I-Skin) Calf Pads- Set - 07540147002497

Individual (moulded i-skin) Calf Pads (Set) for use with Motion Concepts CM Legrests. One-size only. Mounting hardware included.
Motion Concepts Inc
D-0101-0157-MCP
In Commercial Distribution

  • 07540147002497 ()
MCP

  • Wheelchair legrest pad

Surgimap® - 00859699006059

The Surgimap® software assists healthcare professionals in viewing, storing, and measuring images as well as planning orthopedic surgeries. The device allows service providers to perform generic as well as specialty measurements of the images, and to plan surgical procedures. The device also includes tools for measuring anatomical components for placement of surgical implants, and offer online synchronization of the database with the possibility to share data among Surgimap® users. Clinical judgment and experience are required to properly use the software.
NEMARIS, INC
2.X
In Commercial Distribution

  • 00859699006059 ()


  • Patient health record information system
  • Radiological PACS software

Surgimap® - 00859699006042

The Surgimap® software assists healthcare professionals in viewing, storing, and measuring images as well as planning orthopedic surgeries. The device allows service providers to perform generic as well as specialty measurements of the images, and to plan surgical procedures. The device also includes tools for measuring anatomical components for placement of surgical implants, and offer online synchronization of the database with the possibility to share data among Surgimap® users. Clinical judgment and experience are required to properly use the software.
NEMARIS, INC
2.2.9.X
In Commercial Distribution

  • 00859699006042 ()


  • Radiological PACS software
  • Patient health record information system

Maces Back Interface, Recline, Elite Backs (14-18W) - 07540147002930

MACES Back Interface Kit includes mounting hardware to affix a Matrx Elite back (width range of 14W-18W) onto a Motion Concepts Power Positioning System with Recline. MACES hardware allows the for full rotational (multi-axis) angle adjustment of the back support.
Motion Concepts Inc
D-0139-EBMI
In Commercial Distribution

  • 07540147002930 ()
EBMI

  • Wheelchair bracket/mount
  • Wheelchair back rest positioner

AincA® - B00500200SMRI0

Manometer, Pole Mount Clamp, MRI Cond 3T, for 3/8" to 1.5" dia Pole, w/Hardware, fits 00-199-MRI Gauges
ANESTHESIA ASSOCIATES, INC.
00-200-S-MRI
In Commercial Distribution

  • B00500200SMRI0 ()
00-200-S-MRI

  • Airway pressure monitor, non-powered

AincA® - B00500200S0

Manometer, Pole Mount Clamp, Large, for 3/8" to 1.5" dia Pole, w/Hardware, fits all 00-199, 00-274 Gauges
ANESTHESIA ASSOCIATES, INC.
00-200-S
In Commercial Distribution

  • B00500200S0 ()
00-200-S

  • Airway pressure monitor, non-powered

interWORKS - 00850054590121

No Description
Avreo Inc
Version 8.8.0.21349
In Commercial Distribution

  • 00850054590121 ()


  • Radiological PACS software
  • Radiology information system

interWORKS - 00850054590114

No Description
Avreo Inc
Version 8.7.0.21126
In Commercial Distribution

  • 00850054590114 ()


  • Radiological PACS software
  • Radiology information system
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