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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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ZEISS Axiolab - 06909262200293

No Description
Carl Zeiss Suzhou Co., Ltd.
Axiolab 5
In Commercial Distribution

  • 06909262200293 ()
430037-9070-000

  • Basic light microscope

ZEISS Axiolab - 06909262200286

No Description
Carl Zeiss Suzhou Co., Ltd.
Axiolab 5
In Commercial Distribution

  • 06909262200286 ()
430037-9060-000

  • Basic light microscope

ZEISS Axiolab - 06909262200248

No Description
Carl Zeiss Suzhou Co., Ltd.
Axiolab 5
In Commercial Distribution

  • 06909262200248 ()
430037-9021-000

  • Basic light microscope

ZEISS Axiolab - 06909262200231

No Description
Carl Zeiss Suzhou Co., Ltd.
Axiolab 5
In Commercial Distribution

  • 06909262200231 ()
430037-9011-000

  • Basic light microscope

Fibrous 5 Diagnostic Ultrasound System - 06936415975173

No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Fibrous 5
In Commercial Distribution

  • 06936415975173 ()


  • General-purpose ultrasound imaging system

Hepatus 5 Diagnostic Ultrasound System - 06936415970895

No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Hepatus 5
In Commercial Distribution

  • 06936415970895 ()


  • General-purpose ultrasound imaging system

MR-RT - 00884838122123

MR-RT is an add-on to the existing Ingenia 1.5T and 3.0T MR systems that makes the system suitable for MR imaging for radiation therapy planning purposes. MR-RT consists of RTGo SW and MR CouchTop accessory. RTgo is a software that provides MR-RT functionality including MRCAT (MRCAT Prostate, MRCAT Pelvis, MRCAT Brain, MRCAT Head &Neck)
Philips Medical Systems Nederland B.V.
RTgo 5
In Commercial Distribution

  • 00884838122123 ()
781439

  • MRI system application software

WOODPECKER - 06944843610047

Ultrasonic dental scaling/debridement system
Guilin Woodpecker Medical Instrument Co., Ltd.
PT 5
In Commercial Distribution

  • 06944843610047 ()


  • Ultrasonic dental scaling/debridement system

cvi42 - 00882916000011

No Description
Circle Cardiovascular Imaging Inc
5.x
In Commercial Distribution

  • 00882916000011 ()


  • MRI system application software

Nasal Dorsum Style 7 - M724400754S1

Nasal Implant
IMPLANTECH ASSOCIATES, INC.
Size 5
In Commercial Distribution

  • M724400754S1 ()
400-754S

  • Nasal cartilage support implant, non-bioabsorbable

Voloshin Dorsal Columella - M724400654S1

Nasal Implant
IMPLANTECH ASSOCIATES, INC.
Size 5
In Commercial Distribution

  • M724400654S1 ()
400-654S

  • Nasal cartilage support implant, non-bioabsorbable

Curvillinear Chin - M724250354S1

Chin Implant
IMPLANTECH ASSOCIATES, INC.
Size 5
In Commercial Distribution

  • M724250354S1 ()
250-354S

  • Chin prosthesis

Bilateral Groove Chin - M724250854S1

Chin Implant
IMPLANTECH ASSOCIATES, INC.
Size 5
In Commercial Distribution

  • M724250854S1 ()
250-854S

  • Chin prosthesis

V.A.C.INSTILL® - 00878237001639

V.A.C. Instill Irrigation Set
KCI USA, INC.
M6275413/5
Not in Commercial Distribution

  • 00878237001639 ()
  • 00878237001417 ()


  • Negative-pressure wound therapy system pump, electric

V.A.C. ATS™ - 00878237001455

1000 ml canister (with Gel) for VAC ATS Therapy Systems
KCI USA, INC.
M6275093/5
Not in Commercial Distribution

  • 00878237001455 ()
  • 00878237001431 ()


  • Negative-pressure wound therapy system canister

V.A.C.® - 00878237001325

Vac Abdominal Dressing Featuring Sensatrac Technology
KCI USA, INC.
M8275080/5
In Commercial Distribution

  • 00878237001325 ()


  • Negative-pressure wound therapy open-abdomen dressing

V.A.C. ® GRANUFOAM™ - 00878237001127

Vac Granufoam Heel Dressing Featuring Sensatrac Technology
KCI USA, INC.
M8275074/5
In Commercial Distribution

  • 00878237001127 ()
  • 00878237001110 ()


  • Negative-pressure wound therapy system foam dressing, non-antimicrobial

V.A.C.® GRANUFOAM™ - 00878237001103

Vac Granufoam Dressing X-Large Featuring Sensatrac Technology
KCI USA, INC.
M8275065/5
In Commercial Distribution

  • 00878237001103 ()
  • 00878237001097 ()


  • Negative-pressure wound therapy system foam dressing, non-antimicrobial

V.A.C.® GRANUFOAM™ - 00878237001080

Vac Granufoam Hand Dressing Featuring Sensatrac Technology
KCI USA, INC.
M8275064/5
Not in Commercial Distribution

  • 00878237001080 ()
  • 00878237001073 ()


  • Negative-pressure wound therapy system foam dressing, non-antimicrobial

SLUP Nasal Implant - M724SLUP05NS1

Nasal Implant, W=5.0mm H= 3.0mm L=50mm
IMPLANTECH ASSOCIATES, INC.
Size 5
In Commercial Distribution

  • M724SLUP05NS1 ()
SLUP-05-NS

  • Nasal cartilage support implant, non-bioabsorbable

SLUP Nasal Implant - M724SLUP051

Nasal Implant
IMPLANTECH ASSOCIATES, INC.
Size 5
In Commercial Distribution

  • M724SLUP051 ()
SLUP-05

  • Nasal cartilage support implant, non-bioabsorbable

SG Medial Calf Implant - M724SGRTSCM51

Contoured Carving Block Implant
IMPLANTECH ASSOCIATES, INC.
Size 5
In Commercial Distribution

  • M724SGRTSCM51 ()
SG-RTS-C M5

  • Silicone-block tissue reconstructive material

Nasal Implant - M724N5NS1

Nasal Implant
IMPLANTECH ASSOCIATES, INC.
Style 5
In Commercial Distribution

  • M724N5NS1 ()
N 5-NS

  • Nasal cartilage support implant, non-bioabsorbable

Cimeosil® Scar and Laser Gel - M724CSG051

Scar and Laser Gel
IMPLANTECH ASSOCIATES, INC.
5 gram
In Commercial Distribution

  • M724CSG051 ()
  • M724CSG0512PK2 ()
CSG-05

  • Scar-management dressing, reusable

Contoured Carving Block Style 8 - M724CCB851

Contoured Carving Block Implant
IMPLANTECH ASSOCIATES, INC.
Size 5
In Commercial Distribution

  • M724CCB851 ()
CCB8-5

  • Silicone-block tissue reconstructive material

Contoured Carving Block Style 4 - M724CCB451

Contoured Carving Block Style 4
IMPLANTECH ASSOCIATES, INC.
Size 5
In Commercial Distribution

  • M724CCB451 ()
CCB4-5

  • Silicone-block tissue reconstructive material

Contoured Carving Block Style 1 - M724CCB151

Contoured Carving Block Style 1
IMPLANTECH ASSOCIATES, INC.
Size 5
In Commercial Distribution

  • M724CCB151 ()
CCB1-5

  • Silicone-block tissue reconstructive material

Solujet - 00660483210510

Cleaner for ultrasonic cleaning of medical devices
ALCONOX INC
5 Gallon
In Commercial Distribution

  • 00660483210510 ()
2105

  • Medical device cleaning agent

Citrajet - 00660483200511

Cleaner for ultrasonic cleaning of medical devices
ALCONOX INC
5 Gallon
In Commercial Distribution

  • 00660483200511 ()
2005

  • Instrument rinsing agent

Luminox - 00660483190515

Cleaner for ultrasonic cleaning of medical devices
ALCONOX INC
5 Gallon
In Commercial Distribution

  • 00660483190515 ()
1905

  • Medical device cleaning agent

Keylajet - 00660483240517

Cleaner for ultrasonic cleaning of medical devices
ALCONOX INC
5 Gallon
In Commercial Distribution

  • 00660483240517 ()
2405

  • Medical device cleaning agent

Citranox - 00660483180516

Cleaner for ultrasonic cleaning of medical devices
ALCONOX INC
5 Gallon
In Commercial Distribution

  • 00660483180516 ()
1805

  • Instrument rinsing agent

Detergent 8 - 00660483170517

Cleaner for ultrasonic cleaning of medical devices
ALCONOX INC
5 Gallon
In Commercial Distribution

  • 00660483170517 ()
1705

  • Medical device cleaning agent

Liquinox - 00660483120512

Cleaner for ultrasonic cleaning of medical devices
ALCONOX INC
5 Gallon
In Commercial Distribution

  • 00660483120512 ()
1205

  • Medical device cleaning agent

WAM (Work Area Management) - 00664369000752

No Description
Sysmex America, Inc.
5.X
In Commercial Distribution

  • 00664369000752 ()


  • Clinical laboratory information system

H&H Emergency Cricothyrotomy Kit - 00857048006002

One time use sterile emergency airway kit that contains (1) Disposable Scalpel #10 blade, (1) Endotracheal Tube, 6.0 mm cuffed, (1) Curved Crile Hemostat, (1) News Tracheal Hook, (1) 10 cc syringe, (1) 35 cm Bougie and Twill Tape.
H&H MEDICAL CORPORATION
Version 5
In Commercial Distribution

  • 00857048006002 ()

  • Height: 1.75 Inch
  • Width: 4.0 Inch
  • Length: 9.25 Inch
HHECT01

  • Cricothyrotomy kit, single-use

Beeline motIV - 00857362007044

Infusion Set (1.5 ml/hr)
Rex Pj Tech LLC
BL1D01/5
In Commercial Distribution

  • 10857362007041 ()
  • 00857362007044 ()


  • Prefilled mechanical infusion pump/catheter

Glooko Mobile Application - 00855093008033

The Glooko Mobile application for iOS and Android displays retrospective data that is captured from BG meters, insulin pumps and continuous glucose monitors (CGM)
GLOOKO, INC.
5.xx
In Commercial Distribution

  • 00855093008033 ()


  • Clinical management support software

Glooko Mobile Insulin Dosing System (MIDS) Android & iOS Mobile Application - 00855093008002

Glooko Mobile Insulin Dosing System (MIDS) is an insulin dose calculator. The Glooko MIDS Mobile Application is only available to patients who have been prescribed MIDS by their heath care provider. The mobile application can be downloaded by patients from the Google Play Store for Android and from the Apple App Store for iOS operating systems.
GLOOKO, INC.
5.x
In Commercial Distribution

  • 00855093008002 ()


  • Clinical management support software

Hu-Friedy MFG Co., LLC. - 10889950057329

Special 10 Instr Sig, Orng/Yellow Rails
HU-FRIEDY MFG. CO., LLC
IM5103/5
In Commercial Distribution

  • 10889950057329 ()


  • Device sterilization/disinfection container, reusable
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