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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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RAGNELL SCISSORS - 00192896075436

RAGNELL SCISSORS UNDER MINING SPATULATED CURVED BLADES POWER CUT SILVER
SONTEC INSTRUMENTS, INC.
110-318
In Commercial Distribution

  • 00192896075436 ()

  • Length: 9 Inch
110-318

  • General-purpose surgical scissors, reusable

Synergetics - 10841305111438

25ga Stellaris Elite Vitrectomy Probe
SYNERGETICS USA, INC.
SE5625
In Commercial Distribution

  • 20841305111442 ()
  • 10841305111438 ()
SE5625

  • Hereditary cerebral haemorrhage with amyloidosis (Dutch type) IVD, kit, nucleic acid technique (NAT)

Synergetics - 10841305111414

23ga Stellaris Elite Vitrectomy Probe
SYNERGETICS USA, INC.
SE5623
In Commercial Distribution

  • 20841305111428 ()
  • 10841305111414 ()
SE5623

  • Hereditary cerebral haemorrhage with amyloidosis (Dutch type) IVD, kit, nucleic acid technique (NAT)

MES 9000 Musculoskeletal System - D792N9000M0

Now you can have all of these capabilities in one compact system. Surface EMG, range of motion and muscle testing – may be purchased separately or in any combination. The modular design of the MES 9000 allows you to purchase any combination of modules and expand as your practice grows. The MES 9000 --- the modular system that enables you to do a complete, integrated evaluation with objective documentation that supports your diagnosis.
MYOTRONICS NOROMED, INC
N9000M
In Commercial Distribution

  • D792N91500 ()
  • D792N9000M0 ()
  • D792N92000 ()
  • D792N9200S0 ()


  • Virtual-display rehabilitation system, non-supportive, clinical

FIZE kUO Console - 07290019239031

FIZE kUO Console 5G catalog number: FI-FG00-KU00-0006 FIZE kUO console 5G with power box US catalog number: FKUO5.0G_PB_US FIZE kUO console 5G with power supply US catalog number: FKUO5.0G_PS_US
FIZE RESEARCH LTD
5G2
In Commercial Distribution

  • 17290019239038 ()
  • 07290019239031 ()
  • 27290019239035 ()
FI-FG00-KU00-0006

  • Urine monitoring system

FIZE kUO Console - 07290019239024

FIZE kUO Console 2.4G catalog number: FI-FG00-KU00-0005 FIZE kUO Console 2.4G with power box US catalog number: FKUO2.4G_PB_US FIZE kUO Console 2.4G with power supply US catalog number: FKUO2.4G_PS_US
FIZE RESEARCH LTD
2.4G2
In Commercial Distribution

  • 17290019239021 ()
  • 07290019239024 ()
  • 27290019239028 ()
FI-FG00-KU00-0005

  • Urine monitoring system

Quick Washbasin - 05707581000683

No Description
Ropox A/S
With Washbasin
In Commercial Distribution

  • 05707581000683 ()
40-42121-1

  • Height-adjustable washbasin bracket, manual

INSTI HIV-1/HIV-2 Antibody Test - 06865979010184

24 Tests with support materials
Biolytical Laboratories Inc
With Support
Not in Commercial Distribution

  • 06865979010184 ()
90-1018

  • HIV1/HIV2 antigen IVD, kit, rapid ICT, clinical

DELTA 20T - 04053755181322

No Description
Heine Optotechnik GmbH & Co. KG
WITH SCALE
In Commercial Distribution

  • 04053755181322 ()
K-008.34.221

  • Dermatoscope, optical

Talis EMR with +ACG - 00860012608805

Talis EMR with +ACG is software intended to support patient care and billing documentation requirements and process control criteria defined by medical facility
Talis Clinical, LLC
Talis EMR with +ACG
In Commercial Distribution

  • 00860012608805 ()
Talis EMR with +ACG

  • Clinical management support software

MEDLINE - 10193489089073

1ML LL SYRINGE,STERILE,LOW-DEAD SPACE
MEDLINE INDUSTRIES, INC.
SYR101010LD
In Commercial Distribution

  • 20193489089070 ()
  • 10193489089073 ()
  • 30193489089077 ()
SYR101010LD

  • General-purpose syringe, single-use

ClearFit - 00855113008005

Small Static Cranial Implant (Primary and Backup)
LONGEVITI NEURO SOLUTIONS LLC
171710
In Commercial Distribution

  • 00855113008005 ()
  • 10855113008002 ()

  • Area/Surface Area: 60 Square centimeter
171710

  • Cranial resinous compound

Outlook® - 04046964186516

Large Volume Infusion Pump System
B. BRAUN MEDICAL INC.
621-100ES
Not in Commercial Distribution

  • 04046964186516 ()
621-100ES

  • Bedside infusion pump, single-channel

Outlook® - 04046964186554

OUTLOOK 400ES, REFURB
B. BRAUN MEDICAL INC.
621-400ESR
Not in Commercial Distribution

  • 04046964186554 ()
621-400ESR

  • Bedside infusion pump, single-channel

Outlook® - 04046964186547

Outlook® 400ES Safety Infusion Pump System
B. BRAUN MEDICAL INC.
621-400ES
Not in Commercial Distribution

  • 04046964186547 ()
621-400ES

  • Bedside infusion pump, single-channel

Outlook® - 04046964186530

Large Volume Infusion Pump System with Outbound Wireless, Drug Library and Barcoding
B. BRAUN MEDICAL INC.
621-300ES
Not in Commercial Distribution

  • 04046964186530 ()
621-300ES

  • Bedside infusion pump, single-channel

Outlook® - 04046964186523

Large Volume Infusion Pump System with Drug Library and Barcoding
B. BRAUN MEDICAL INC.
621-200ES
Not in Commercial Distribution

  • 04046964186523 ()
621-200ES

  • Bedside infusion pump, single-channel

Outlook® - 04046964186493

OUTLOOK 100, REFURB
B. BRAUN MEDICAL INC.
620-100R
Not in Commercial Distribution

  • 04046964186493 ()
620-100R

  • Bedside infusion pump, single-channel

APEX™ - 04046964801082

APEX, CONTROL MODULE - TPN MANAGER
B. BRAUN MEDICAL INC.
601227
In Commercial Distribution

  • 04046964801082 ()
601227

  • Intravenous solution compounder

APEX™ - 04046964801068

APEX, CONTROL MODULE
B. BRAUN MEDICAL INC.
601224
In Commercial Distribution

  • 04046964801068 ()
601224

  • Intravenous solution compounder

APEX™ - 04046964801051

APEX, PUMP MODULE
B. BRAUN MEDICAL INC.
601223
In Commercial Distribution

  • 04046964801051 ()
601223

  • Intravenous solution compounder

APEX™ - 04046964801044

APEX, LOAD CELL MODULE
B. BRAUN MEDICAL INC.
601220
In Commercial Distribution

  • 04046964801044 ()
601220

  • Intravenous solution compounder

Infusomat® - 04046964958304

INFUSOMAT SPACE ACM-KIT, ASSET
B. BRAUN MEDICAL INC.
8713060U-99
In Commercial Distribution

  • 04046964958304 ()
8713060U-99

  • Bedside infusion pump, single-channel

Infusomat® - 04046964958281

ASSET, INFUSOMAT SPACE US + STD BATTERY
B. BRAUN MEDICAL INC.
8713052U-99
In Commercial Distribution

  • 04046964958281 ()
8713052U-99

  • Bedside syringe pump

Infusomat® - 04046964958274

INFUSOMAT SPACE - US VERSION ASSET
B. BRAUN MEDICAL INC.
8713050U-99
In Commercial Distribution

  • 04046964958274 ()
8713050U-99

  • Bedside syringe pump

Perfusor® - 04046964958250

PERFUSOR SPACE ACM-KIT, ASSET
B. BRAUN MEDICAL INC.
8713040U-99
In Commercial Distribution

  • 04046964958250 ()
8713040U-99

  • Bedside syringe pump

Perfusor® - 04046964958243

PERFUSOR SPACE - US VERSION ASSET
B. BRAUN MEDICAL INC.
8713030U-99
In Commercial Distribution

  • 04046964958243 ()
8713030U-99

  • Bedside syringe pump

NA - 04046964958212

EXTERNAL BOLUS BUTTON ASSET
B. BRAUN MEDICAL INC.
8710988-99
In Commercial Distribution

  • 04046964958212 ()
8710988-99

  • Bedside syringe pump

Infusomat® - 04046964958205

IV POLE CLAMP ASSET
B. BRAUN MEDICAL INC.
8710929-99
In Commercial Distribution

  • 04046964958205 ()
8710929-99

  • Frame/rail/pole device holder

Vista® - 04046964958199

VISTA BASIC IFVB ASSET
B. BRAUN MEDICAL INC.
637-20299
In Commercial Distribution

  • 04046964958199 ()
637-20299

  • Bedside infusion pump, single-channel
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