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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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Shepherd - 10850026568629

0.014" Shepherd ES Guidewire - straight 300 cm - 12 gms
Cardiovascular Systems, Inc.
PSP14S-30012
In Commercial Distribution

  • 30850026568623 ()
  • 10850026568629 ()

  • Guidewire Diameter: 0.014 Inch
  • Length: 300 Centimeter
  • Hydrophilic Coating
  • Tip Flex 12 Grams
  • Tip Shape Straight
  • Tip Design Polymer Jacket
7-10097-02

  • Peripheral vascular guidewire, manual

Shepherd - 10850026568612

0.014" Shepherd ES Guidewire - straight 195 cm - 12 gms
Cardiovascular Systems, Inc.
PSP14S-19512
In Commercial Distribution

  • 30850026568616 ()
  • 10850026568612 ()

  • Guidewire Diameter: 0.014 Inch
  • Length: 195 Centimeter
  • Hydrophilic Coating
  • Tip Flex 12 Grams
  • Tip Shape Straight
  • Tip Design Polymer Jacket
7-10097-01

  • Peripheral vascular guidewire, manual

Shepherd - 10850026568605

0.018" Shepherd ES Guidewire - straight 300 cm - 6 gms
Cardiovascular Systems, Inc.
PSP18S-30006
In Commercial Distribution

  • 30850026568609 ()
  • 10850026568605 ()

  • Guidewire Diameter: 0.018 Inch
  • Length: 300 Centimeter
  • Hydorphilic Coating
  • Tip Flex 6 Grams
  • Tip Shape Straight
  • Tip Design Polymer Jacket
7-10096-08

  • Peripheral vascular guidewire, manual

Shepherd - 10850026568599

0.018" Shepherd ES Guidewire - straight 195 cm - 6 gms
Cardiovascular Systems, Inc.
PSP18S-19506
In Commercial Distribution

  • 30850026568593 ()
  • 10850026568599 ()

  • Guidewire Diameter: 0.018 Inch
  • Length: 195 Centimeter
  • Hydrdophilic Coating
  • Tip Flex 6 Grams
  • Tip Shape Straight
  • Tip Design Polymer Jacket
7-10096-07

  • Peripheral vascular guidewire, manual

Shepherd - 10850026568582

0.014" Shepherd ES Guidewire - straight 300 cm - 6 gms
Cardiovascular Systems, Inc.
PSP14S-30006
In Commercial Distribution

  • 30850026568586 ()
  • 10850026568582 ()

  • Guidewire Diameter: 0.014 Inch
  • Length: 300 Centimeter
  • Hydrophilic Coating
  • Tip Flex 6 Grams
  • Tip Shape Straight
  • Tip Design Polymer Jacket
7-10096-06

  • Peripheral vascular guidewire, manual

Shepherd - 10850026568575

0.014" Shepherd ES Guidewire - straight 195 cm - 6 gms
Cardiovascular Systems, Inc.
PSP14S-19506
In Commercial Distribution

  • 30850026568579 ()
  • 10850026568575 ()

  • Guidewire Diameter: 0.014 Inch
  • Length: 195 Centimeter
  • Hydrophilic Coating
  • Tip Flex 6 Grams
  • Tip Shape Straight
  • Tip Design Polymer Jacket
7-10096-05

  • Peripheral vascular guidewire, manual

Shepherd - 10850026568568

0.018" Shepherd ES Guidewire - straight 300 cm - 4 gms
Cardiovascular Systems, Inc.
PSP18S-30004
In Commercial Distribution

  • 30850026568562 ()
  • 10850026568568 ()

  • Guidewire Diameter: 0.018 Inch
  • Length: 300 Centimeter
  • Hydrophilic Coating
  • Tip Flex 4 Grams
  • Tip Shape Straight
  • Tip Design Polymer Jacket
7-10096-04

  • Peripheral vascular guidewire, manual

Shepherd - 10850026568551

0.018" Shepherd ES Guidewire - straight 195 cm - 4 gms
Cardiovascular Systems, Inc.
PSP18S-19504
In Commercial Distribution

  • 30850026568555 ()
  • 10850026568551 ()

  • Guidewire Diameter: 0.018 Inch
  • Length: 195 Centimeter
  • Hydorphilic Coating
  • Tip Flex 4 grams
  • Tip Shape Straight
  • Tip Design Polymer Jacket
7-10096-03

  • Peripheral vascular guidewire, manual

Shepherd - 10850026568544

0.014" Shepherd ES Guidewire - straight 300 cm - 4 gms
Cardiovascular Systems, Inc.
PSP14S-30004
In Commercial Distribution

  • 10850026568544 ()

  • Guidewire Diameter: 0.014 Inch
  • Length: 300 Centimeter
  • Hydrophilic Coating
  • Tip Flex 4 grams
  • Tip Shape Straighht
  • Tip Design Polymer Jacket
7-10096-02

  • Peripheral vascular guidewire, manual

Shepherd - 10850026568537

0.014" Shepherd ES Guidewire - straight 195 cm - 4 gms
Cardiovascular Systems, Inc.
PSP14S-19504
In Commercial Distribution

  • 30850026568531 ()
  • 10850026568537 ()

  • Guidewire Diameter: 0.014 Inch
  • Length: 195 Inch
  • Hydrophilic Coating
  • Tip Flex 4 Grams
  • Tip Shape Straight
  • Tip Design Polymer Jacket
7-10096-01

  • Peripheral vascular guidewire, manual

NA - 04055207070086

CHECKLIST APP This app requires core.portal. The checklist app is a universal questionnaire and checklist system for collecting information during surgery. Checklists can be defined as customer-specific multilingual templates. The checklists are displayed in accordance with the language selected in the core.browser. The app generates a PDF report with the demographic patient data, information about the surgical intervention, a logo and the recorded data. The report is part of the documentation. The app does not spread the information collected.
Richard Wolf GmbH
5597706
Not in Commercial Distribution

  • 04055207070086 ()
5597706

  • Operating room audiovisual data/device management system application software

FIBRIJET - 00815634020184

MANUAL ENDOSCOPIC SPRAY APP. W/MIX TIP 5MM X 40CM,11:1 RATIO
Micromedics, Inc.
SA-3667
In Commercial Distribution

  • 00815634020184 ()
  • 10815634020181 ()
  • 20815634020188 ()


  • Open-surgery adhesive/sealant applicator, dual-channel

OvuSense - 05060508530121

M400 OvuFirst Starter Pack - M426 OvuFirst Skin Worn Sensor and M032 OvuSense App
VIO HEALTHTECH LIMITED
M400
In Commercial Distribution

  • 05060508530121 ()


  • Thermometric fertility analyser

CipherOx CRI - 00860003025604

The CRI app provides the patient's individual-specific measure of the Compensatory Reserve Index.
FLASHBACK TECHNOLOGIES, INC.
CRI
In Commercial Distribution

  • 00860003025604 ()


  • Pulse oximeter probe, single-use

MIR - 08052990321711

Smart Spirometer and Oximeter connected to an app available on a smart phone
MIR MEDICAL INTERNATIONAL RESEARCH SPA
Spirobank Oxi
In Commercial Distribution

  • 08052990321711 ()


  • Expiratory peak flow meter, digital
  • Pulse oximeter

MIR - 08052990321704

Smart Spirometer and Oximeter connected to an app available on a smart phone
MIR MEDICAL INTERNATIONAL RESEARCH SPA
Smart One Oxi
In Commercial Distribution

  • 08052990321704 ()


  • Expiratory peak flow meter, digital
  • Pulse oximeter

DRIVEMEDICAL - 00822383135809

Pressure PreventionGroup 1 Surfaces Product Description: APP Sys,Dlx,Variable Pressure,1/ea
Drive Devilbiss Healthcare
14001E
In Commercial Distribution

  • 00822383135809 ()
  • 50822383135804 ()


  • Alternating-pressure bed mattress overlay, reusable
  • Alternating-pressure inflator
  • Alternating-pressure bed mattress overlay system

Aaris Acrylic Intraocular lens(IOL) - 00884872015894

https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageDataLoaded=false&pageMode=edit&deviceRecordKey=30865#
Aaren Scientific Inc.
EC-3
In Commercial Distribution

  • 00884872015894 ()


  • Posterior-chamber intraocular lens, pseudophakic

Symmetry Bookwalter® - 00887482172339

Bookwalter® Retractor Set, Anterior Lumbar Spinalhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
SYMMETRY SURGICAL INC.
50-5740
In Commercial Distribution

  • 00887482172339 ()
50-5740

  • Surgical retractor/retraction system blade, reusable

Needle Holder - 10840199506122

Jacobson Needle Holder Micro Tungsten Grip Straight 21cmhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
KOROS U.S.A., INC.
7064-30
In Commercial Distribution

  • 00840199506125 ()
  • 10840199506122 ()

  • 9x12mm
7064-30

  • Suturing needle holder, reusable

HARVEST® SmartJet® - 05020583514546

SmartJet® Dual Liquid Applicator Kit, LK/7 SmartJet 7 in. Liquid App. Kit
TERUMO BCT, INC.
51454
Not in Commercial Distribution

  • 05020583514546 ()
  • 35020583514547 ()


  • Haematological concentrate/haemostatic agent applicator

McKessan - 00612479258181

Pressure Prevention Group 1 Surfaces Product Description APP Sys,Dlx,Variable Pressure,1/ea
Drive Devilbiss Healthcare
146-14001E
In Commercial Distribution

  • 00612479258181 ()


  • Alternating-pressure bed mattress overlay system
  • Alternating-pressure bed mattress overlay, reusable
  • Alternating-pressure inflator

ProView Plus - H816MPM10161

Self Sealing Sterilization Pouch, 10"x 16"https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
MicroCare, LLC
PM1016
In Commercial Distribution

  • H816MPM10160 ()
  • H816MPM10161 ()
  • H816PM10161 ()
PM1016-1

  • Sterilization packaging, single-use

DRIVEMEDICAL - 00822383110769

Pressure PreventionGroup 1 Surfaces Product Description: APP Pad, w/End Flaps,1/ea, RTL
Drive Devilbiss Healthcare
14003-EF
In Commercial Distribution

  • 50822383110764 ()
  • 00822383110769 ()


  • Alternating-pressure bed mattress overlay, reusable
  • Alternating-pressure inflator
  • Alternating-pressure bed mattress overlay system

DRIVEMEDICAL - 00822383135816

Pressure PreventionGroup 1 Surfaces Product Description: APP Sys,Standard,Fixed Pressure,1/ea,RTL
Drive Devilbiss Healthcare
14002E
In Commercial Distribution

  • 00822383135816 ()
  • 50822383135811 ()


  • Alternating-pressure bed mattress overlay, reusable
  • Alternating-pressure inflator
  • Alternating-pressure bed mattress overlay system

Airo™ CPAP Mask Liners - 20850054813309

Evaluation Pack - Airo™ CPAP Mask Liners - Box of 50 - Medium
Athfar 828 Inc
EVAL-AM-50
In Commercial Distribution

  • 00850054813305 ()
  • 20850054813309 ()
EVAL-AM-50

  • General-purpose medical fibre padding

Airo™ CPAP Mask Liners - 20850054813286

Sample - Airo™ CPAP Mask Liners - Box of 50 - Large
Athfar 828 Inc
SMPL-AL-50
In Commercial Distribution

  • 00850054813282 ()
  • 20850054813286 ()


  • General-purpose medical fibre padding

Airo™ CPAP Mask Liners - 20850054813248

Sample - Airo™ CPAP Mask Liners - Box of 50 - Medium
Athfar 828 Inc
SMPL-AM-50
In Commercial Distribution

  • 00850054813244 ()
  • 20850054813248 ()


  • General-purpose medical fibre padding

Airo™ CPAP Mask Liners - 20850054813200

Sample - Airo™ CPAP Mask Liners - Box of 50 - Small
Athfar 828 Inc
SMPL-AS-50
In Commercial Distribution

  • 00850054813206 ()
  • 20850054813200 ()


  • General-purpose medical fibre padding

Airo™ CPAP Mask Liners - 20850054813118

Sample - Airo™ CPAP Mask Liners - Box of 50 - Large
Athfar 828 Inc
SMPL-AL-50
Not in Commercial Distribution

  • 00850054813114 ()
  • 20850054813118 ()
SMPL-AL-50

  • General-purpose medical fibre padding

Airo™ CPAP Mask Liners - 20850054813101

Sample - Airo™ CPAP Mask Liners - Box of 50 - Medium
Athfar 828 Inc
SMPL-AM-50
Not in Commercial Distribution

  • 00850054813107 ()
  • 20850054813101 ()
SMPL-AM-50

  • General-purpose medical fibre padding

Airo™ CPAP Mask Liners - 20850054813095

Sample - Airo™ CPAP Mask Liners - Box of 50 - Small
Athfar 828 Inc
SMPL-AS-50
Not in Commercial Distribution

  • 00850054813091 ()
  • 20850054813095 ()
SMPL-AS-50

  • General-purpose medical fibre padding

Breathe Pure - 00810021178363

No Description
Dongguan SIMZO Electronic Technology Co., Ltd.
HW-F7
In Commercial Distribution

  • 10810021178377 ()
  • 00810021178363 ()
  • 20810021178428 ()
  • 30810021178050 ()


  • Infrared patient thermometer, skin

KKmier - 00810021178219

No Description
Dongguan SIMZO Electronic Technology Co., Ltd.
HW-F7
In Commercial Distribution

  • 10810021178216 ()
  • 00810021178219 ()
  • 20810021178220 ()


  • Infrared patient thermometer, skin

WISHDREAM - 00810021178158

No Description
Dongguan SIMZO Electronic Technology Co., Ltd.
HW-F7
In Commercial Distribution

  • 10810021178155 ()
  • 00810021178158 ()
  • 20810021178169 ()


  • Infrared patient thermometer, skin

konjac - 00810021178134

No Description
Dongguan SIMZO Electronic Technology Co., Ltd.
HW-F7
In Commercial Distribution

  • 10810021178131 ()
  • 00810021178134 ()


  • Infrared patient thermometer, skin

K&FCOPTEE - 06977160620055

No Description
Shangrao Zhuofan intelligent technology Co., LTD
ZF-M607
In Commercial Distribution

  • 06977160620055 ()


  • Air-conduction hearing aid, in-the-ear

K&FCOPTEE - 06977160620048

No Description
Shangrao Zhuofan intelligent technology Co., LTD
ZF-M609
In Commercial Distribution

  • 06977160620048 ()


  • Air-conduction hearing aid, in-the-ear

K&FCOPTEE - 06977160620031

No Description
Shangrao Zhuofan intelligent technology Co., LTD
ZF-M908
In Commercial Distribution

  • 06977160620031 ()


  • Air-conduction hearing aid, behind-the-ear

K&FCOPTEE - 06977160620024

No Description
Shangrao Zhuofan intelligent technology Co., LTD
ZF-M802
In Commercial Distribution

  • 06977160620024 ()


  • Air-conduction hearing aid, behind-the-ear

K&FCOPTEE - 06977160620017

No Description
Shangrao Zhuofan intelligent technology Co., LTD
ZF-M606
In Commercial Distribution

  • 06977160620017 ()


  • Air-conduction hearing aid, in-the-ear

EMST150 - 00793573085498

EMST150 expiratory muscle strength trainer (handheld exerciser ).The EMST150 is a calibrated muscle strength trainer designed specifically for individuals who want to increase the strength of their voice,cough and swallow muscles
Aspire Products LLC
150
In Commercial Distribution

  • 00793573085498 ()


  • PEEP valve, reusable

Medical Reverse Osmosis - B297KROUPT5600

UPT-560 Medical RO - 6 Membrane - 10 gpm Permeate Production
SPECIALITY WATER TECHNOLOGY
K-RO-UPT-560
In Commercial Distribution

  • B297KROUPT5600 ()


  • Reverse-osmosis water purification system

SCOOP - B181C9HF20

Transtracheal Catheters and Cleaning Rods (Two Pack) 9cm
TRANSTRACHEAL SYSTEMS, INC.
C-9HF-2
In Commercial Distribution

  • B181C9HF20 ()
C-9HF-2

  • Oxygen administration transtracheal catheter

SCOOP - B181C920

Transtracheal Catheters and Cleaning Rods (Two Pack) 9cm
TRANSTRACHEAL SYSTEMS, INC.
C-9-2
In Commercial Distribution

  • B181C920 ()
C-9-2

  • Oxygen administration transtracheal catheter

SCOOP - B181C90

Transtracheal Catheter and Cleaning Rod (Single Pack) 9cm
TRANSTRACHEAL SYSTEMS, INC.
C-9
In Commercial Distribution

  • B181C90 ()
C-9

  • Oxygen administration transtracheal catheter

SCOOP - B181C11HF20

Transtracheal Catheters and Cleaning Rods (Two Pack) 11cm
TRANSTRACHEAL SYSTEMS, INC.
C-11HF-2
In Commercial Distribution

  • B181C11HF20 ()
C-11HF-2

  • Oxygen administration transtracheal catheter

SCOOP - B181C1120

Transtracheal Catheters and Cleaning Rods (Two Pack) 11cm
TRANSTRACHEAL SYSTEMS, INC.
C-11-2
In Commercial Distribution

  • B181C1120 ()
C-11-2

  • Oxygen administration transtracheal catheter

SCOOP - B181C110

Transtracheal Catheter and Cleaning Rod (Single Pack) 11cm
TRANSTRACHEAL SYSTEMS, INC.
C-11
In Commercial Distribution

  • B181C110 ()
C-11

  • Oxygen administration transtracheal catheter

Airo™ CPAP Mask Liners - 10850054813319

Evaluation Pack - Airo™ CPAP Mask Liners - Box of 25 - Small
Athfar 828 Inc
EVAL-AS-25
In Commercial Distribution

  • 00850054813312 ()
  • 10850054813319 ()
EVAL-AS-25

  • General-purpose medical fibre padding
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