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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Stainless Steel Cooling coil BC 60 plus CDI Sat Cell 1/4" System 100 Gas Filter Temperature Probe
DATASCOPE CORP.
BO-T 46201
Not in Commercial Distribution

  • 00607567207974 ()
709000133

  • Cardiopulmonary bypass system blood tubing set
No Description
DATASCOPE CORP.
BO-T 36503
Not in Commercial Distribution

  • 00607567205529 ()
701065590

  • Cardiopulmonary bypass system blood tubing set
BO-RF 32
DATASCOPE CORP.
BO-T 41301
Not in Commercial Distribution

  • 00607567205253 ()
701065209

  • Cardiopulmonary bypass system blood tubing set
No Description
DATASCOPE CORP.
BO-T 30902
Not in Commercial Distribution

  • 00607567204942 ()
701062807

  • Cardiopulmonary bypass system blood tubing set
Softshell Venous Reser. 800ml, Gish Bladder Bag 30ml 1/4, Blood Microfilter System SQ 40 S, Prebypass filter w/o Vent Porous Media 3/8x3/8, Gas Filter
DATASCOPE CORP.
BO-T 13303
Not in Commercial Distribution

  • 00607567202665 ()
701052539

  • Cardiopulmonary bypass system blood tubing set
No Description
DATASCOPE CORP.
BO-T 2917
Not in Commercial Distribution

  • 00607567202092 ()
701053384

  • Cardiopulmonary bypass system blood tubing set
BO-RF32 RotaFlow
DATASCOPE CORP.
BO-T 22800
Not in Commercial Distribution

  • 00607567201774 ()
701051272

  • Cardiopulmonary bypass system blood tubing set
No Description
DATASCOPE CORP.
BO-T 45105
Not in Commercial Distribution

  • 00607567212107 ()
709000506

  • Cardiopulmonary bypass system blood tubing set
BO-RF32 RotaFlow, Gas Filter
DATASCOPE CORP.
BO-T 41301
In Commercial Distribution

  • 00607567211742 ()
701065209R01

  • Cardiopulmonary bypass system blood tubing set
BO-RF32 RotaFlow, BMU Cell Ven. 1/2, Arterial Sensor 3/8" (BMU), Prebypass filter w/o Vent Porous Media 3/8x1/2, Gas Filter
DATASCOPE CORP.
BO-T 26300
Not in Commercial Distribution

  • 00607567211650 ()
701066738R01

  • Cardiopulmonary bypass system blood tubing set
Stainless Steel Cooling coil, BC 60 plus, CDI Sat Cell 3/8" System 100, Gas Filter, Temperature Probe
DATASCOPE CORP.
BO-T 2303
Not in Commercial Distribution

  • 00607567211551 ()
709000004R01

  • Cardiopulmonary bypass system blood tubing set
No Description
DATASCOPE CORP.
BO-T 52303
In Commercial Distribution

  • 00607567211544 ()
709000408

  • Cardiopulmonary bypass system blood tubing set
Softshell Venous Reser. 1900ml w. connector 700000292, BO-RF32 RotaFlow, Gas Filter
DATASCOPE CORP.
BO-T 39705
In Commercial Distribution

  • 00607567211490 ()
709000415

  • Cardiopulmonary bypass system blood tubing set
No Description
DATASCOPE CORP.
BO-T 14608
Not in Commercial Distribution

  • 00607567211476 ()
709000224

  • Cardiopulmonary bypass system blood tubing set
No Description
DATASCOPE CORP.
BO-T 14607
Not in Commercial Distribution

  • 00607567211469 ()
709000222

  • Cardiopulmonary bypass system blood tubing set
No Description
DATASCOPE CORP.
BO-T 14606
Not in Commercial Distribution

  • 00607567211452 ()
709000220

  • Cardiopulmonary bypass system blood tubing set
IOS Implant Replica Nobel Biocare N1™ TCC RP
Nobel Biocare AB
300965
In Commercial Distribution

  • 07332747177008 ()
300965

  • Dental implant suprastructure, temporary, preformed, single-use
IOS Implant Replica Nobel Biocare N1™ TCC NP
Nobel Biocare AB
300964
In Commercial Distribution

  • 07332747176995 ()
300964

  • Dental implant suprastructure, temporary, preformed, single-use
IOS Implant Replica Nobel Biocare N1™ TCC RP
Nobel Biocare AB
300965
In Commercial Distribution

  • 07332747162899 ()
300965

  • Dental implant suprastructure, temporary, preformed, single-use
IOS Implant Replica Nobel Biocare N1™ TCC NP
Nobel Biocare AB
300964
In Commercial Distribution

  • 07332747162882 ()
300964

  • Dental implant suprastructure, temporary, preformed, single-use
IOS Implant Replica Nobel Biocare N1™ TCC RP
Nobel Biocare AB
300965
In Commercial Distribution

  • 07332747214222 ()
300965

  • Dental implant suprastructure, temporary, preformed, single-use
IOS Implant Replica Nobel Biocare N1™ TCC NP
Nobel Biocare AB
300964
In Commercial Distribution

  • 07332747214215 ()
300964

  • Dental implant suprastructure, temporary, preformed, single-use
t:connect Mobile Application, Mobile Bolus Enabled, 2.x (iOS)
Tandem Diabetes Care, Inc.
1007111
In Commercial Distribution

  • 90850018992452 ()


  • Ambulatory insulin infusion pump software, data-display
  • Ambulatory insulin infusion pump remote control
US Dexcom Follow App for iOS, (mg/dL), v4
Dexcom, Inc.
SW10497
In Commercial Distribution

  • 00386270001931 ()


  • Percutaneous interstitial-fluid glucose monitoring system, electrochemical
APP, Bluetooth, otoTune iOS for self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990019-SWH
In Commercial Distribution

  • 00850016231383 ()


  • Audiometric/hearing device software
Hygieia d-Nav System Phone App - Apple iOS Operating System
HYGIEIA, INC.
V1m00b054i
In Commercial Distribution

  • 00860001044201 ()


  • Calculator, programmable
iOS mobile device software for use with Eko products.
Eko Devices, Inc.
3.1.1
In Commercial Distribution

  • 00863609000334 ()


  • Medical equipment clinical data interfacing software
A digital epilepsy care management platform application for iOS.
Ai Nile Inc
Nile for iOS
In Commercial Distribution

  • 00850031821002 ()


  • Medication reminder application software
Software, Sonicare Power Tooth brush, Web download App iOS
PHILIPS ORAL HEALTHCARE, LLC
HX9999/99
In Commercial Distribution

  • 08710103988977 ()


  • Basic electric toothbrush
Vial Adapter 20mm ML TG SS Blue SIL- VF
WEST PHARMA. SERVICES IL, . LTD
8072028
Not in Commercial Distribution

  • 27290108240003 ()
  • 17290108240006 ()
  • 07290108240009 ()


  • Vial/bottle adaptor, non-hermetic
Mix2Vial™ 20/20mm w/15µm Large Filter TG
WEST PHARMA. SERVICES IL, . LTD
8074046
In Commercial Distribution

  • 27290108240997 ()
  • 17290108240990 ()
  • 07290108240993 ()


  • Medication transfer needle, filtering
VA 20mm FLL SIL w/25μm Filter TG - VF
WEST PHARMA. SERVICES IL, . LTD
8072114
In Commercial Distribution

  • 27290108240669 ()
  • 17290108240662 ()
  • 07290108240665 ()


  • Vial/bottle adaptor, non-hermetic
Mix2Vial 20/20mm W/20mic large filter TG S-Spike
WEST PHARMA. SERVICES IL, . LTD
8074022
In Commercial Distribution

  • 27290108240423 ()
  • 17290108240426 ()
  • 07290108240429 ()


  • Medication transfer needle, filtering
XiVE® TG Titanium Bar Coping with Guide Pin
Dentsply Implants Manufacturing GmbH
32254241
Not in Commercial Distribution

25-4241

  • Dental implant suprastructure, permanent, preformed
XiVE® TG Gold Bar Coping with Guide Pin
Dentsply Implants Manufacturing GmbH
32254240
Not in Commercial Distribution

25-4240

  • Dental implant suprastructure, permanent, preformed
XiVE® TG Lab Set Implant-/Soldering Analog Bar
Dentsply Implants Manufacturing GmbH
32259306
Not in Commercial Distribution

  • EFRI322593062 ()
25-9306

  • Dental implant suprastructure kit
XiVE® TG Lab Set Implant-/Soldering Analog Bridge
Dentsply Implants Manufacturing GmbH
32259305
Not in Commercial Distribution

  • EFRI322593052 ()
25-9305

  • Dental implant suprastructure kit
XiVE® TG Titanium Bar Coping with Guide Pin
Dentsply Implants Manufacturing GmbH
32254241
Not in Commercial Distribution

  • EFRI322542412 ()
25-4241

  • Dental implant suprastructure, permanent, preformed
XiVE® TG Gold Bar Coping with Guide Pin
Dentsply Implants Manufacturing GmbH
32254240
Not in Commercial Distribution

  • EFRI322542402 ()
25-4240

  • Dental implant suprastructure, permanent, preformed
Titan Design 4.8mm Tg Hex Abutment Plastic Sleeve Non-Hex
TITAN IMPLANT INC
TN-48TGIAPSNH
In Commercial Distribution

  • 00842448112361 ()


  • Dental implant suprastructure, temporary, preformed, single-use
Titan Design 4.8mm Tg Hex Abutment Plastic Sleeve Hex
TITAN IMPLANT INC
TN-48TGIAPSH
In Commercial Distribution

  • 00842448112354 ()


  • Dental implant suprastructure, temporary, preformed, single-use
Periodontal chisel # 13K/TG "Kirkland" COMFORT | SL | double ended
devemed GmbH
02-KL 13K-TG C
In Commercial Distribution

  • 04061644036561 ()


  • Orthopaedic chisel
Periodontal chisel # 13K/TG "Kirkland" F-LINE | SL | double ended
devemed GmbH
KL 13K-TG F
In Commercial Distribution

  • 04061644022250 ()


  • Orthopaedic chisel
LOCATOR Abutment for Platform "M" Premium TG x 5.0mm
Zest Anchors, LLC
2092
In Commercial Distribution

  • 00840481117879 ()

  • Length: 5 Millimeter
2092

  • Dental implant suprastructure, permanent, preformed
LOCATOR Abutment for Platform "M" Premium TG x 4.0mm
Zest Anchors, LLC
2091
In Commercial Distribution

  • 00840481117862 ()

  • Length: 4 Millimeter
2091

  • Dental implant suprastructure, permanent, preformed
LOCATOR Abutment for Platform "M" Premium TG x 3.0mm
Zest Anchors, LLC
2090
In Commercial Distribution

  • 00840481117855 ()

  • Length: 3 Millimeter
2090

  • Dental implant suprastructure, permanent, preformed
LOCATOR Abutment for Platform "W" Premium TG x 6.0mm
Zest Anchors, LLC
2086
In Commercial Distribution

  • 00840481117817 ()

  • Length: 6 Millimeter
2086

  • Dental implant suprastructure, permanent, preformed
LOCATOR Abutment for Platform "W" Premium TG x 5.0mm
Zest Anchors, LLC
2085
In Commercial Distribution

  • 00840481117800 ()

  • Length: 5 Millimeter
2085

  • Dental implant suprastructure, permanent, preformed
LOCATOR Abutment for Platform "W" Premium TG x 4.0mm
Zest Anchors, LLC
2084
In Commercial Distribution

  • 00840481117794 ()

  • Length: 4 Millimeter
2084

  • Dental implant suprastructure, permanent, preformed
LOCATOR Abutment for Platform "W" Premium TG x 3.0mm
Zest Anchors, LLC
2083
In Commercial Distribution

  • 00840481117787 ()

  • Length: 3 Millimeter
2083

  • Dental implant suprastructure, permanent, preformed
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