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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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Bakes common bile duct dilators, 9'', 8.0mm
AMBLER SURGICAL CORP.
Bakes common bile duct dilators
In Commercial Distribution

  • 00190660029487 ()
43-908

  • Urethral bougie, reusable
Bakes common bile duct dilators, 9'', 7.0mm
AMBLER SURGICAL CORP.
Bakes common bile duct dilators
In Commercial Distribution

  • 00190660029470 ()
43-907

  • Urethral bougie, reusable
Bakes common bile duct dilators, 9'', 6.0mm
AMBLER SURGICAL CORP.
Bakes common bile duct dilators
In Commercial Distribution

  • 00190660029463 ()
43-906

  • Urethral bougie, reusable
Bakes common bile duct dilators, 9'', 5.0mm
AMBLER SURGICAL CORP.
Bakes common bile duct dilators
In Commercial Distribution

  • 00190660029456 ()
43-905

  • Urethral bougie, reusable
Bakes common bile duct dilators, 9'', 4.0mm
AMBLER SURGICAL CORP.
Bakes common bile duct dilators
In Commercial Distribution

  • 00190660029449 ()
43-904

  • Urethral bougie, reusable
Bakes common bile duct dilators, 9'', 3.0mm
AMBLER SURGICAL CORP.
Bakes common bile duct dilators
In Commercial Distribution

  • 00190660029432 ()
43-903

  • Urethral bougie, reusable
Bakes common bile duct dilators, 9'', 2.0mm
AMBLER SURGICAL CORP.
Bakes common bile duct dilators
In Commercial Distribution

  • 00190660029425 ()
43-902

  • Urethral bougie, reusable
Bakes common bile duct dilators, 9'', 13.0mm
AMBLER SURGICAL CORP.
Bakes common bile duct dilators
In Commercial Distribution

  • 00190660029418 ()
43-913

  • Urethral bougie, reusable
Bakes common bile duct dilators, 9'', 12.0mm
AMBLER SURGICAL CORP.
Bakes common bile duct dilators
In Commercial Distribution

  • 00190660029401 ()
43-912

  • Urethral bougie, reusable
Bakes common bile duct dilators, 9'', 11.0mm
AMBLER SURGICAL CORP.
Bakes common bile duct dilators
In Commercial Distribution

  • 00190660029395 ()
43-911

  • Urethral bougie, reusable
Bakes common bile duct dilators, 9'', 10.0mm
AMBLER SURGICAL CORP.
Bakes common bile duct dilators
In Commercial Distribution

  • 00190660029388 ()
43-910

  • Urethral bougie, reusable
Bakes common bile duct dilators, 9'', 1.0mm
AMBLER SURGICAL CORP.
Bakes common bile duct dilators
In Commercial Distribution

  • 00190660029371 ()
43-901

  • Urethral bougie, reusable
Gregory Common Femoral Artery Clamp, Curved Left
Avalign Technologies, Inc.
P42340
Not in Commercial Distribution

  • 00190776025090 ()

  • Length: 5.5 Inch


  • Surgical soft-tissue manipulation forceps, scissors-like, reusable
Gregory Common Femoral Artery Clamp, Curved Right
Avalign Technologies, Inc.
P41247
Not in Commercial Distribution

  • 00190776025083 ()

  • Length: 5.5 Inch


  • Surgical soft-tissue manipulation forceps, scissors-like, reusable
Large Acutrak 2® Common Inst. Platter
Acumed LLC
80-0871
In Commercial Distribution

  • 10806378045431 ()


  • General internal orthopaedic fixation system implantation kit
Apex Knee System Common Instruments Pan Insert
Omni Life Science, Inc.
KS-90079-IN
In Commercial Distribution

  • 00841690195078 ()
KS-90079-IN

  • Instrument tray, reusable
COMPR FT SCRW SYS CADDY,COMMON INST
ARTHREX, INC.
AR-8738C-01
In Commercial Distribution

  • 00888867127388 ()
AR-8738C-01

  • Device sterilization/disinfection container, reusable
IVD reagent kit containing 6 tests
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0142
In Commercial Distribution

  • 00815381020321 ()


  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
IVD reagent kit containing 30 tests
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0143
In Commercial Distribution

  • 00815381020314 ()


  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Abys® Medical Cysware® 4H web platform is a web-based medical device designed and intended for use prior to surgery to gather in one place the information needed by the surgeon to make a surgical planning. As a result, a planning assistance file is created and contains medical imaging, 3d models, documents, and notes. The ABYS® MEDICAL Cysware® 4H web platform is used to export the planning assistance file to the Abys® Medical Cysart® 4H mixed reality application, another medical software.
ABYS MEDICAL
1.xx.xxx
In Commercial Distribution

  • 03760365550004 ()
H001-WEB001

  • Radiology DICOM image processing application software
The Quick-20m is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
CGX, LLC
SYS-0001-D
In Commercial Distribution

  • 00860009903715 ()
SYS-0001-D

  • Multiple physiological signal amplifier
leyla brain retractors accessories, for mounting retractor to the operating table, coupling head to hold up to flexible arms
NOVO SURGICAL, INC.
N6860-53
In Commercial Distribution

  • 00842331119309 ()


  • Self-retaining surgical retractor, reusable
XScribe 6 upgrade server interface to convert system to a Client that connects to a remote modality manager database
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094261226 ()
UPGXS6-A-SVR-A

  • Electrocardiographic lead set, reusable
4300 PEAK FLOW METER myPEF (NON WEB)
VITALOGRAPH (IRELAND) LIMITED
4300
In Commercial Distribution

  • 55099169439004 ()
  • 35099169439000 ()
  • 05099169439009 ()


  • Expiratory peak flow meter, analogue, reusable
DreamMapper Web North American Instance, Version 2.17
Respironics, Inc.
2.17
In Commercial Distribution

  • 00606959054189 ()
1101679

  • Self-care monitoring/reporting software
Tandem Source Web Application v 3.X
Tandem Diabetes Care, Inc.
1011061
In Commercial Distribution

  • 00389152106113 ()
1011061

  • Ambulatory insulin infusion pump software, data-display
The Leopold Surf The Web Blue Spectacle
Kenmark Optical, Inc.
LEOPBL53
In Commercial Distribution

  • 00715317221153 ()


  • Prescription spectacles
The Noonan Surf The Web Blue Spectacle
Kenmark Optical, Inc.
NNANBL50
In Commercial Distribution

  • 00715317221030 ()


  • Prescription spectacles
The Stratton Surf The Web Blue Spectacle
Kenmark Optical, Inc.
STONBL54
In Commercial Distribution

  • 00715317220729 ()


  • Prescription spectacles
The Stratton Surf The Web Blue Spectacle
Kenmark Optical, Inc.
STONBL52
In Commercial Distribution

  • 00715317220712 ()


  • Prescription spectacles
The Stewart Surf The Web Blue Spectacle
Kenmark Optical, Inc.
STWRBL49
In Commercial Distribution

  • 00715317208321 ()


  • Prescription spectacles
The Saul-a Surf The Web Blue Spectacle
Kenmark Optical, Inc.
SALABL55
In Commercial Distribution

  • 00715317206617 ()


  • Prescription spectacles
CUP PETITE WEB LF PPL 144CT SAMPLE
YOUNG DENTAL MANUFACTURING I, LLC
054601sample
In Commercial Distribution

  • 00302730003291 ()
  • 10302730003298 ()


  • Dental polishing cup, single-use
WEB LF SFT PPL SCR 144 SAMPLE
YOUNG DENTAL MANUFACTURING I, LLC
054101sample
In Commercial Distribution

  • 10302730003274 ()
  • 00302730003277 ()


  • Dental polishing cup, single-use
WEB I MOL BANDS G8424-17+G2820-00 LL1
LEONE SPA
E8971-01
In Commercial Distribution

  • 08033707085133 ()
E8971-01

  • Orthodontic metal band
SENTINEL 10 WORKSTATION (X1) + 4 WEB LICENSES
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522123221 ()
040-1713-00

  • Cardiology information system application software
SENTINEL 10 WORKSTATION (X1) + 4 WEB LICENSES
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522103131 ()
040-1713-00

  • Cardiology information system application software
1.5MM TI VAL WEB PLATE 14 HOLES-STERILE
Synthes GmbH
04.130.261S
In Commercial Distribution

  • H67904130261S0 ()
  • 10886982113092 ()
04130261S

  • Orthopaedic fixation plate, non-bioabsorbable
1.5MM TI VAL WEB PLATE 14 HOLES
Synthes GmbH
04.130.261
In Commercial Distribution

  • H679041302610 ()
  • 10886982113085 ()
04130261

  • Orthopaedic fixation plate, non-bioabsorbable
1.3MM TI LCKNG WEB PLATE 14 HOLES-STERILE
Synthes GmbH
04.130.161S
In Commercial Distribution

  • H67904130161S0 ()
  • 10886982112682 ()
04130161S

  • Orthopaedic fixation plate, non-bioabsorbable
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