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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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2.7mm Wise-Lock Screws, Self Tapping, Length 10 mm - 08903993252048

Screws are used to affix the plate to the bone
Auxein Medical Private Limited
118.010
In Commercial Distribution

  • 08903993252048 ()
A3-DND-QF-001-WF3

  • Orthopaedic bone screw (non-sliding)

2.4mm Wise-Lock Screws, Self Tapping, Length 8 mm - 08903993249871

Screws are used to affix the plate to the bone
Auxein Medical Private Limited
TI-M17.08
In Commercial Distribution

  • 08903993249871 ()
A3-DND-QF-001-WF3

  • Orthopaedic bone screw (non-sliding)

2.4mm Wise-Lock Screws, Self Tapping, Length 6mm - 08903993249857

Screws are used to affix the plate to the bone
Auxein Medical Private Limited
TI-M17.06
In Commercial Distribution

  • 08903993249857 ()
A3-DND-QF-001-WF3

  • Orthopaedic bone screw (non-sliding)

2.4mm Wise-Lock Screws, Self Tapping, Length 30 mm - 08903993249741

Screws are used to affix the plate to the bone
Auxein Medical Private Limited
TI-M17.30
In Commercial Distribution

  • 08903993249741 ()
A3-DND-QF-001-WF3

  • Orthopaedic bone screw (non-sliding)

2.4mm Wise-Lock Screws, Self Tapping, Length 28 mm - 08903993249734

Screws are used to affix the plate to the bone
Auxein Medical Private Limited
TI-M17.28
In Commercial Distribution

  • 08903993249734 ()
A3-DND-QF-001-WF3

  • Orthopaedic bone screw (non-sliding)

2.4mm Wise-Lock Screws, Self Tapping, Length 26 mm - 08903993249727

Screws are used to affix the plate to the bone
Auxein Medical Private Limited
TI-M17.26
In Commercial Distribution

  • 08903993249727 ()
A3-DND-QF-001-WF3

  • Orthopaedic bone screw (non-sliding)

2.4mm Wise-Lock Screws, Self Tapping, Length 24 mm - 08903993249710

Screws are used to affix the plate to the bone
Auxein Medical Private Limited
TI-M17.24
In Commercial Distribution

  • 08903993249710 ()
A3-DND-QF-001-WF3

  • Orthopaedic bone screw (non-sliding)

2.4mm Wise-Lock Screws, Self Tapping, Length 22 mm - 08903993249703

Screws are used to affix the plate to the bone
Auxein Medical Private Limited
TI-M17.22
In Commercial Distribution

  • 08903993249703 ()
A3-DND-QF-001-WF3

  • Orthopaedic bone screw (non-sliding)

2.4mm Wise-Lock Screws, Self Tapping, Length 20 mm - 08903993249697

Screws are used to affix the plate to the bone
Auxein Medical Private Limited
TI-M17.20
In Commercial Distribution

  • 08903993249697 ()
A3-DND-QF-001-WF3

  • Orthopaedic bone screw (non-sliding)

2.4mm Wise-Lock Screws, Self Tapping, Length 18 mm - 08903993249680

Screws are used to affix the plate to the bone
Auxein Medical Private Limited
TI-M17.18
In Commercial Distribution

  • 08903993249680 ()
A3-DND-QF-001-WF3

  • Orthopaedic bone screw (non-sliding)

2.4mm Wise-Lock Screws, Self Tapping, Length 16 mm - 08903993249673

Screws are used to affix the plate to the bone
Auxein Medical Private Limited
TI-M17.16
In Commercial Distribution

  • 08903993249673 ()
A3-DND-QF-001-WF3

  • Orthopaedic bone screw (non-sliding)

2.4mm Wise-Lock Screws, Self Tapping, Length 14 mm - 08903993249666

Screws are used to affix the plate to the bone
Auxein Medical Private Limited
TI-M17.14
In Commercial Distribution

  • 08903993249666 ()
A3-DND-QF-001-WF3

  • Orthopaedic bone screw (non-sliding)

2.4mm Wise-Lock Screws, Self Tapping, Length 12 mm - 08903993249642

Screws are used to affix the plate to the bone
Auxein Medical Private Limited
TI-M17.12
In Commercial Distribution

  • 08903993249642 ()
A3-DND-QF-001-WF3

  • Orthopaedic bone screw (non-sliding)

2.4mm Wise-Lock Screws, Self Tapping, Length 10 mm - 08903993249628

Screws are used to affix the plate to the bone
Auxein Medical Private Limited
TI-M17.10
In Commercial Distribution

  • 08903993249628 ()
A3-DND-QF-001-WF3

  • Orthopaedic bone screw (non-sliding)

Foreign Body Removal Set - 05060745557110

No Description
BLINK MEDICAL LIMITED
76-0073
In Commercial Distribution

  • 05060745557127 ()
  • 05060745557110 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use

DOPPLER 811-BTS 24V FOREIGN - 00816787020342

No Description
PARKS MEDICAL ELECTRONICS, INC.
811-BTS 24V (F)
In Commercial Distribution

  • 00816787020342 ()


  • Laser Doppler blood flowmeter

811-BL 24V FOREIGN & DOMESTIC - 00816787020328

No Description
PARKS MEDICAL ELECTRONICS, INC.
811-BL 24V NV
In Commercial Distribution

  • 00816787020328 ()


  • Laser Doppler blood flowmeter

811-BL 24V FOREIGN & DOMESTIC - 00816787020311

No Description
PARKS MEDICAL ELECTRONICS, INC.
811-BL 24V 901C
In Commercial Distribution

  • 00816787020311 ()


  • Laser Doppler blood flowmeter

811-BL 24V FOREIGN & DOMESTIC - 00816787020298

No Description
PARKS MEDICAL ELECTRONICS, INC.
811-BL 24V 800C
In Commercial Distribution

  • 00816787020298 ()


  • Laser Doppler blood flowmeter

Plange Foreign Body Spud - 08175700114066

Double Ended Foreign Body Spud
AURORA SURGICAL, LLC
AS4-026
In Commercial Distribution

  • 08175700114066 ()
AS4-026

  • Ophthalmic surgical probe, reusable

FRANCIS FOREIGN BODY SPUD - 00192896012608

FRANCIS FOREIGN BODY ANGLED FLAG SHAPED TIP
SONTEC INSTRUMENTS, INC.
11-3750
In Commercial Distribution

  • 00192896012608 ()
11-3750

  • Eye spud

DreamMapper Mobile App Android (APAC) - 00606959048553

DreamMapper Mobile App Android (APAC)
Respironics, Inc.
2.9
In Commercial Distribution

  • 00606959048553 ()
1127960

  • Self-care monitoring/reporting software

DreamMapper Mobile App Android (EMEA) - 00606959048546

DreamMapper Mobile App Android (EMEA)
Respironics, Inc.
2.9
In Commercial Distribution

  • 00606959048546 ()
1128265

  • Self-care monitoring/reporting software

DreamMapper Mobile App Android (DMM) - 00606959048539

DreamMapper Mobile App Android (DMM)
Respironics, Inc.
2.9
In Commercial Distribution

  • 00606959048539 ()
1101479

  • Self-care monitoring/reporting software

Dexcom G7 Wear OS Watch App - 00386270005175

G7 Wear OS Watch App
Dexcom, Inc.
SW14502
In Commercial Distribution

  • 00386270005175 ()


  • Percutaneous interstitial-fluid glucose monitoring system, electrochemical

DreamMapper - 00606959057678

DreamMapper Mobile App Android (APAC)
Respironics, Inc.
DreamMapper Mobile App Android, Asia- Pacific Instance - 2
In Commercial Distribution

  • 00606959057678 ()
1127960

  • Self-care monitoring/reporting software

DreamMapper - 00606959057661

DreamMapper Mobile App Android (EMEA)
Respironics, Inc.
DreamMapper Mobile App Android EMEA, - 2
In Commercial Distribution

  • 00606959057661 ()
1128265

  • Self-care monitoring/reporting software

DreamMapper - 00606959057654

DreamMapper Mobile App Android (DMM)
Respironics, Inc.
DreamMapper Mobile App Android, North America Instance - 2
In Commercial Distribution

  • 00606959057654 ()
1101479

  • Self-care monitoring/reporting software

CARDINAL HEALTH - 10888439686432

ALLENTOWN LAP CHOLE APP PACK
Cardinal Health 200, LLC
SBA11LLSL1
In Commercial Distribution

  • 50888439686430 ()
  • 10888439686432 ()
SBA11LLSL1

  • Laparoscopic surgical procedure kit, non-medicated, single-use

N/A - 00613994377517

SOFTWARE 9733467 FUSION ENT APP
MEDTRONIC NAVIGATION, INC.
9733467
In Commercial Distribution

  • 00613994377517 ()


  • ENT stereotactic surgery system

CARDINAL HEALTH - 10888439463965

ALLENTOWN LAP CHOLE APP PACK
Cardinal Health 200, LLC
SBA11LLSLA
In Commercial Distribution

  • 50888439463963 ()
  • 10888439463965 ()
SBA11LLSLA

  • Laparoscopic surgical procedure kit, non-medicated, single-use

Medline - 10080196403905

SYSTEM,APP,AIRONE, 220 VOLT
MEDLINE INDUSTRIES, INC.
MSCAIRONE220
In Commercial Distribution

  • 10080196403905 ()
MSCAIRONE220

  • Alternating-pressure bed mattress overlay, reusable

CARDINAL HEALTH - 10888439768442

ALLENTOWN LAP CHOLE APP PACK
Cardinal Health 200, LLC
SBA11LLSL2
In Commercial Distribution

  • 50888439768440 ()
  • 10888439768442 ()
SBA11LLSL2

  • Laparoscopic surgical procedure kit, non-medicated, single-use

Neutral - 05714464033829

FW updater App 1.0.0 iOS
Sbo Hearing A/S
232872
In Commercial Distribution

  • 05714464033829 ()


  • Hearing aid wireless-fitting computer-aided set

GN Hearing - 05708296074242

APP,GNH TUNER,3.4,IOS
Gn Hearing A/S
20416900
In Commercial Distribution

  • 05708296074242 ()


  • Hearing aid/implant system remote control

Beltone - 05708296074228

APP,BT HEARP,3.4,IOS
Gn Hearing A/S
20416700
In Commercial Distribution

  • 05708296074228 ()


  • Hearing aid/implant system remote control

GN ReSound - 05708296074204

APP,RS SMART,3.4,IOS
Gn Hearing A/S
20416500
In Commercial Distribution

  • 05708296074204 ()


  • Hearing aid/implant system remote control

Beltone - 05708296071548

APP,BT HEARMAX,1.0,ANDR
Gn Hearing A/S
20410900
In Commercial Distribution

  • 05708296071548 ()


  • Hearing aid/implant system remote control

Beltone - 05708296071531

APP,BT HEARMAX,1.0,IOS
Gn Hearing A/S
20410800
In Commercial Distribution

  • 05708296071531 ()


  • Hearing aid/implant system remote control

GN ReSound - 05708296071449

APP,RS CONTROL,1.0.6,ANDR
Gn Hearing A/S
20409900
In Commercial Distribution

  • 05708296071449 ()


  • Hearing aid/implant system remote control

GN ReSound - 05708296071432

APP,RS CONTROL,1.0.6,IOS
Gn Hearing A/S
20409500
In Commercial Distribution

  • 05708296071432 ()


  • Hearing aid/implant system remote control

GN Hearing - 05708296070831

APP,GNH TUNER,3.3.2,IOS
Gn Hearing A/S
20402100
In Commercial Distribution

  • 05708296070831 ()


  • Hearing aid/implant system remote control

Beltone - 05708296070824

APP,BT HEARP,3.3.2,IOS
Gn Hearing A/S
20401900
In Commercial Distribution

  • 05708296070824 ()


  • Hearing aid/implant system remote control

GN ReSound - 05708296070817

APP,RS SMART,3.3.2,IOS
Gn Hearing A/S
20401700
In Commercial Distribution

  • 05708296070817 ()


  • Hearing aid/implant system remote control

GN Hearing - 05708296074259

APP,GNH TUNER,3.4,ANDR
Gn Hearing A/S
20417000
In Commercial Distribution

  • 05708296074259 ()


  • Hearing aid/implant system remote control

Beltone - 05708296074235

APP,BT HEARP,3.4,ANDR
Gn Hearing A/S
20416800
In Commercial Distribution

  • 05708296074235 ()


  • Hearing aid/implant system remote control

GN ReSound - 05708296074211

APP,RS SMART,3.4,ANDR
Gn Hearing A/S
20416600
In Commercial Distribution

  • 05708296074211 ()


  • Hearing aid/implant system remote control

Cell Therapy 360 Wearable Tech V1 - 00851203006272

BMS CT360 Clinician Web App
BLUE SPARK TECHNOLOGIES, INC.
BMS CT360 Clinician Web App
Not in Commercial Distribution

  • 00851203006272 ()


  • Wireless patient monitor/sensor reporting software, layperson-use

Cell Therapy 360 Wearable Tech V1 - 00851203006265

BMS CT360 Andriod Clinician App
BLUE SPARK TECHNOLOGIES, INC.
BMS CT360 Andriod Clinician App
Not in Commercial Distribution

  • 00851203006265 ()


  • Wireless patient monitor/sensor reporting software, layperson-use

Cell Therapy 360 Wearable Tech V1 - 00851203006258

BMS CT360 iOS Clinician App
BLUE SPARK TECHNOLOGIES, INC.
BMS CT360 iOS Clinician App
Not in Commercial Distribution

  • 00851203006258 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
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