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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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Optetrak Logic - 10885862623812

CC Reamer
Exactech, Inc.
SPI-001086
In Commercial Distribution

  • 10885862623812 ()
SPI-001086

  • Bone-resection orthopaedic reamer, reusable

NA - 10885862295521

VERIFICATOR CC
Exactech, Inc.
521-50-05
In Commercial Distribution

  • 10885862295521 ()
521-50-05

  • Orthopaedic stereotactic surgery system

CEKA & PRECI-LINE ATTACHMENTS - 04260576942845

PRECI-CLIX CC
Alphadent NV
1256
In Commercial Distribution

  • 04260576942845 ()

  • ball with female and housing
  • Height: 4.1 Millimeter
1256

  • Bar dental precision attachment

AoN Implants - 00840192701503

Analog - CC
FAICO MEDICAL LLC
AAN000000000C
Not in Commercial Distribution

  • 00840192701503 ()


  • Dental implant system

STRIPPER - 00888937907919

STRIPPER CC
ORIGIO INC.
MXL3-STR-CC
In Commercial Distribution

  • 00888937907919 ()


  • Assisted reproduction microtool

SoNoNav® Calibration App - 00643169183407

SOFTWARE 9734472 SONONAV CAL APP FOR SC
MEDTRONIC NAVIGATION, INC.
9734472
In Commercial Distribution

  • 00643169183407 ()


  • Multi-purpose stereotactic surgery system

DreamMapper - 00606959054288

DreamMapper App iOS, Asia-Pacific Instance, version 2.17
Respironics, Inc.
2.17
In Commercial Distribution

  • 00606959054288 ()
1127959

  • Self-care monitoring/reporting software

DreamMapper - 00606959054271

DreamMapper App iOS, EMEA Instance, version 2.17
Respironics, Inc.
2.17
In Commercial Distribution

  • 00606959054271 ()
1128264

  • Self-care monitoring/reporting software

Laryseal Blue Laryngeal Mask Airway Slimline Pack Size 2 - 05055788777694

https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
FLEXICARE MEDICAL LIMITED
038-94-620U
In Commercial Distribution

  • 05055788777694 ()


  • Laryngeal mask airway, single-use

Halo Systems - 05690977308695

OB V2 RING KIT TI LG-No App
OSSUR AMERICAS, INC.
515500V2
Not in Commercial Distribution

  • 05690977308695 ()
515500V2

  • Cervical spine immobilization head ring

Halo Systems - 05690977308688

OB V2 RING KIT TI STD-No App
OSSUR AMERICAS, INC.
515400V2
Not in Commercial Distribution

  • 05690977308688 ()
515400V2

  • Cervical spine immobilization head ring

Halo Systems - 05690977308671

OB V2 RING KIT TI SM-No App
OSSUR AMERICAS, INC.
515300V2
Not in Commercial Distribution

  • 05690977308671 ()
515300V2

  • Cervical spine immobilization head ring

Thermo Scientific - 00673693398602

Rabbit Polyclonal Anti-Human Amyloid Precursor Protein (APP)
RICHARD-ALLAN SCIENTIFIC COMPANY
RB-9023-R7
In Commercial Distribution

  • 00673693398602 ()

  • Total Volume: 7 Milliliter


  • Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry

Thermo Scientific - 00673693398572

Rabbit Polyclonal Anti-Human Amyloid Precursor Protein (APP)
RICHARD-ALLAN SCIENTIFIC COMPANY
RB-9023-P1
In Commercial Distribution

  • 00673693398572 ()

  • Total Volume: 0.5 Milliliter


  • Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry

Thermo Scientific - 00673693398565

Rabbit Polyclonal Anti-Human Amyloid Precursor Protein (APP)
RICHARD-ALLAN SCIENTIFIC COMPANY
RB-9023-P0
In Commercial Distribution

  • 00673693398565 ()

  • Total Volume: 0.1 Milliliter


  • Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry

Thermo Scientific - 00673693398558

Rabbit Polyclonal Anti-Human Amyloid Precursor Protein (APP)
RICHARD-ALLAN SCIENTIFIC COMPANY
RB-9023-P
In Commercial Distribution

  • 00673693398558 ()

  • Total Volume: 1 Milliliter


  • Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry

Navina™ Smart App for Android - 07392532242380

Navina Smart Transanal Irrigation. Bowel diary APP
Wellspect AB
75751
Not in Commercial Distribution

  • 07392532242380 ()
75751

  • Rectal irrigation system application software

Navina™ Smart App for iOS - 07392532242373

Navina Smart Transanal Irrigation. Bowel diary APP
Wellspect AB
75750
Not in Commercial Distribution

  • 07392532242373 ()
75750

  • Rectal irrigation system application software

8-Chamber Arm & Shoulder Sleeve - Medium, Left - 00812311029119

https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
Bio Compression Systems, Inc
G8-3035-SH-M-L
In Commercial Distribution

  • 00812311029119 ()


  • Multi-chamber venous compression system garment, reusable

8-Chamber Arm & Shoulder Sleeve - Medium, Left - 00812311020062

https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
Bio Compression Systems, Inc
G8-3035-SH-M-L-BT
In Commercial Distribution

  • 00812311020062 ()


  • Multi-chamber venous compression system garment, reusable

BioPure 4400 RO - 00817492021969

https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
MAR COR PURIFICATION, INC.
102M16B2E
In Commercial Distribution

  • 00817492021969 ()

  • Width: 38 Inch
  • Depth: 29 Inch
  • Height: 80.5 Inch
  • Weight: 783 Pound


  • Reverse-osmosis water purification system

Meridian Medical - 00815067040179

APP PAD W/O HEAD & FOOT FLAPS
COMPASS HEALTH BRANDS CORP.
1002
In Commercial Distribution

  • 30815067040170 ()
  • 00815067040179 ()


  • Alternating-pressure bed mattress overlay, reusable

HANSATON stream remote 5.X - 07613389610932

A mobile app for HANSATON hearing instruments
Sonova AG
088-5018
In Commercial Distribution

  • 07613389610932 ()


  • Audiometric/hearing device software

AccuRelief - 00023601291011

App Control for ACRL-9100 Device v.1
COMPASS HEALTH BRANDS CORP.
ACRL-9100APP
In Commercial Distribution



  • Physical therapy transcutaneous neuromuscular electrical stimulation system

AccuRelief - 00023601091000

App Control for ACRL-9100 Device v.0
COMPASS HEALTH BRANDS CORP.
ACRL-9100APP
Not in Commercial Distribution

  • 00023601091000 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system

Drive - 00822383227788

APP System, Standard, 220 Volt, 1/ea
Drive Devilbiss Healthcare
14002E-220
Not in Commercial Distribution

  • 10822383227785 ()
  • 00822383227788 ()


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

Drive - 00822383580913

Symphony True LAL & APP Matt Repl Sys
Drive Devilbiss Healthcare
14500
Not in Commercial Distribution

  • 00822383580913 ()


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

Navina™ Smart App for Android - 07333387030395

Navina Smart Transanal Irrigation. Bowel diary APP
Wellspect AB
75751
In Commercial Distribution

75751

  • Rectal irrigation system application software

Navina™ Smart App for iOS - 07333387030388

Navina Smart Transanal Irrigation. Bowel diary APP
Wellspect AB
75750
In Commercial Distribution

75750

  • Rectal irrigation system application software

Guardian™ Connect App - 00763000186333

SFTWR CSS7200 GRDN MBL APP IOS V3.2.3
MEDTRONIC MINIMED, INC.
CSS7200
In Commercial Distribution

  • 00763000186333 ()


  • Patient health record information system application software

Sugar.IQ™ - 00763000168643

SFTWR MMT-8100 IOS WATSON APP V3.0 UDI
MEDTRONIC MINIMED, INC.
MMT-8100
In Commercial Distribution

  • 00763000168643 ()


  • Self-care monitoring/reporting software

Guardian™ Connect App - 00763000381097

SFTWR CSS7201 GRDN MBL APP ANDRD V4.1.1
MEDTRONIC MINIMED, INC.
CSS7201
In Commercial Distribution

  • 00763000381097 ()


  • Patient health record information system application software

N/A - 00763000533199

SW APP A71300 SCS CLINICIAN TRIALING 2.0
MEDTRONIC, INC.
A71300
In Commercial Distribution

  • 00763000533199 ()


  • Multiple active implantable device programmer

CareLink SmartSync™ LINQ II™ Platform Application - 00763000891091

SW D00U027 SS LINQ II PLATFORM APP
MEDTRONIC, INC.
D00U027
In Commercial Distribution

  • 00763000891091 ()


  • Implantable cardiac device management application software

InPen - 00763000974596

SW MMT-8061 INPEN 2.0 ANDROID APP US
MEDTRONIC MINIMED, INC.
MMT-8061
In Commercial Distribution

  • 00763000974596 ()


  • Empty self-injector, mechanical

InPen - 00763000974589

SW MMT-8060 INPEN 2.0 IOS APP US
MEDTRONIC MINIMED, INC.
MMT-8060
In Commercial Distribution

  • 00763000974589 ()


  • Empty self-injector, mechanical

Sugar.IQ™ - 00763000086619

SFTWR MMT-8100 IOS WATSON APP V2.1 UDI
MEDTRONIC MINIMED, INC.
MMT-8100
In Commercial Distribution

  • 00763000086619 ()


  • Self-care monitoring/reporting software

Dexcom G5 Mobile Android App - 00386270000293

G5 Mobile Android App Stand Alone Software
Dexcom, Inc.
SW10940
In Commercial Distribution

  • 00386270000293 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical

Dexcom G5 Mobile IOS App - 00386270000002

G5 Mobile IOS App Stand Alone Software
Dexcom, Inc.
SW10611
In Commercial Distribution

  • 00386270000002 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical

Dover - 10192253028775

IRRIGATION 1200 CC TRAY, 60 CC BULB SYRINGE, 500 CC CONTAINER, TIP PROTECTOR, ALCOHOL, LIDDED
Cardinal Health 200, LLC
67800
In Commercial Distribution

  • 50192253028773 ()
  • 10192253028775 ()

  • Total Volume: 60 Milliliter
67800

  • Irrigation syringe
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