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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AirStrip Cardiology, Patient Monitoring and OB - Client iOS
Airstrip Technologies, Inc.
2001
In Commercial Distribution

  • B15320010 ()


  • Bedside monitor remote-viewing software, physiological parameter
FLIN FLON - TG - Toffee Grain - 47 * 19 - 145
Incite International Inc
2552TG
In Commercial Distribution

  • G1312552TG0 ()
  • 00810109935437 ()


  • Spectacle frame
NobelProcera® IOS Model Implant Replica CC WP
Nobel Biocare AB
38191
In Commercial Distribution

  • 07332747212570 ()
38191

  • Dental implant suprastructure, temporary, preformed, single-use
NobelProcera® IOS Model Implant Replica CC RP
Nobel Biocare AB
38190
In Commercial Distribution

  • 07332747212563 ()
38190

  • Dental implant suprastructure, temporary, preformed, single-use
NP IOS Model Implant Replica Conical Connection NP
Nobel Biocare AB
38189
In Commercial Distribution

  • 07332747212556 ()
38189

  • Dental implant suprastructure, temporary, preformed, single-use
NobelProcera® IOS Model Implant Replica CC 3.0
Nobel Biocare AB
38188
In Commercial Distribution

  • 07332747212549 ()

  • Outer Diameter: 3.000 Millimeter
38188

  • Dental implant suprastructure, temporary, preformed, single-use
Mix2Vial 20/20mm 5mic filter TG S- Spike
WEST PHARMA. SERVICES IL, . LTD
8074020
In Commercial Distribution

  • 27290108240386 ()
  • 17290108240389 ()
  • 07290108240382 ()


  • Medication transfer needle, filtering
VA 20mm FLL TG- VF for J&J
WEST PHARMA. SERVICES IL, . LTD
8072030
In Commercial Distribution

  • 27290108240218 ()
  • 17290108240211 ()
  • 07290108240214 ()


  • Vial/bottle adaptor, non-hermetic
Vial Adapter 20mm w/15μm Filter TG –VF
WEST PHARMA. SERVICES IL, . LTD
8072109
In Commercial Distribution

  • 27290108240195 ()
  • 07290108240191 ()


  • Vial/bottle adaptor, non-hermetic
NobelProcera® IOS Replica Insertion Tool CC WP
Nobel Biocare AB
38204
In Commercial Distribution

  • 07332747096422 ()
38204

  • Dental implant suprastructure, temporary, preformed, reusable
NobelProcera® IOS Replica Insertion Tool CC RP
Nobel Biocare AB
38203
In Commercial Distribution

  • 07332747096415 ()
38203

  • Dental implant suprastructure, temporary, preformed, reusable
NobelProcera® IOS Replica Insertion Tool CC NP
Nobel Biocare AB
38201
In Commercial Distribution

  • 07332747096408 ()
38201

  • Dental implant suprastructure, temporary, preformed, reusable
NobelProcera® IOS Replica Insertion Tool CC 3.0
Nobel Biocare AB
38200
In Commercial Distribution

  • 07332747096392 ()

  • Outer Diameter: 3.000 Millimeter
38200

  • Dental implant suprastructure, temporary, preformed, reusable
NobelProcera® IOS Model Implant Replica CC WP
Nobel Biocare AB
38191
In Commercial Distribution

  • 07332747096316 ()
38191

  • Dental implant suprastructure, temporary, preformed, single-use
NobelProcera® IOS Model Implant Replica CC RP
Nobel Biocare AB
38190
In Commercial Distribution

  • 07332747096309 ()
38190

  • Dental implant suprastructure, temporary, preformed, single-use
NP IOS Model Implant Replica Conical Connection NP
Nobel Biocare AB
38189
In Commercial Distribution

  • 07332747096293 ()
38189

  • Dental implant suprastructure, temporary, preformed, single-use
NobelProcera® IOS Model Implant Replica CC 3.0
Nobel Biocare AB
38188
In Commercial Distribution

  • 07332747096286 ()

  • Outer Diameter: 3.000 Millimeter
38188

  • Dental implant suprastructure, temporary, preformed, single-use
XiVE® TG Lab Set Soldering Analog Bar
Dentsply Implants Manufacturing GmbH
32254106
Not in Commercial Distribution

25-4106

  • Dental implant suprastructure kit
XiVE® TG Lab Set Soldering Analog Bridge
Dentsply Implants Manufacturing GmbH
32254105
Not in Commercial Distribution

25-4105

  • Dental implant suprastructure kit
SCREW SR-6000 6mm f/Stimloc f/TG AIMD
MEDTRONIC, INC.
SR-6000
In Commercial Distribution

  • 20613994747895 ()
  • 00613994747891 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
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
BC 60 plus, Blood Microfilter System SQ 40 S, Gas Filter
DATASCOPE CORP.
BO-T 37311
Not in Commercial Distribution

  • 00607567211384 ()
709000237

  • Cardiopulmonary bypass system blood tubing set
Softshell Venous Reser. 800ml, Blood Transfer Bag 1000 ml - 2 spike ports, Gas Filter
DATASCOPE CORP.
BO-T 51502
Not in Commercial Distribution

  • 00607567211346 ()
709000385

  • Cardiopulmonary bypass system blood tubing set
No Description
DATASCOPE CORP.
BO-T 4930
Not in Commercial Distribution

  • 00607567211278 ()
709000383

  • Cardiopulmonary bypass system blood tubing set
No Description
DATASCOPE CORP.
BO-T 37309
Not in Commercial Distribution

  • 00607567211049 ()
701068727

  • Cardiopulmonary bypass system blood tubing set
No Description
DATASCOPE CORP.
BO-T 37307
Not in Commercial Distribution

  • 00607567211032 ()
701068723

  • Cardiopulmonary bypass system blood tubing set
No Description
DATASCOPE CORP.
BO-T 55004
Not in Commercial Distribution

  • 00607567211025 ()
709000276

  • Cardiopulmonary bypass system blood tubing set
No Description
DATASCOPE CORP.
BO-T 55003
Not in Commercial Distribution

  • 00607567211018 ()
709000274

  • Cardiopulmonary bypass system blood tubing set
No Description
DATASCOPE CORP.
BO-T 55002
Not in Commercial Distribution

  • 00607567211001 ()
709000272

  • Cardiopulmonary bypass system blood tubing set
No Description
DATASCOPE CORP.
BO-T 55001
Not in Commercial Distribution

  • 00607567210998 ()
709000270

  • Cardiopulmonary bypass system blood tubing set
No Description
DATASCOPE CORP.
BO-T 55000
Not in Commercial Distribution

  • 00607567210981 ()
709000268

  • Cardiopulmonary bypass system blood tubing set
BO-RF32 RotaFlow,
DATASCOPE CORP.
BO-T 8040
Not in Commercial Distribution

  • 00607567210165 ()
709000323

  • Cardiopulmonary bypass system blood tubing set
Softshell Venous Reser. 1900ml w. connector 700000292 BO-RF32 RotaFlow Gas Filter
DATASCOPE CORP.
BO-T 53500
In Commercial Distribution

  • 00607567208612 ()
709000226

  • Cardiopulmonary bypass system blood tubing set
Stainless Steel Cooling coil BC 60 plus CDI Sat Cell 1/4" System 100 Gas Filter Temperature Probe
DATASCOPE CORP.
BO-T 46200
Not in Commercial Distribution

  • 00607567208063 ()
701065620

  • 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

  • 00607567208056 ()
709000004

  • Cardiopulmonary bypass system blood tubing set
Stainless Steel Cooling coil, BC 60 plus, CDI Sat Cell 3/8" System 100, Gas Filter and Temperature Probe.
DATASCOPE CORP.
BO-T 2302
Not in Commercial Distribution

  • 00607567208049 ()
709000006

  • Cardiopulmonary bypass system blood tubing set
Blood Transfer Bag 600 ml
DATASCOPE CORP.
BO-T 41302
Not in Commercial Distribution

  • 00607567208001 ()
701066291

  • Cardiopulmonary bypass system blood tubing set
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 31205
Not in Commercial Distribution

  • 00607567207004 ()
70900009

  • Cardiopulmonary bypass system blood tubing set
No Description
DATASCOPE CORP.
BO-T 25106
Not in Commercial Distribution

  • 00607567206953 ()
701068046

  • Cardiopulmonary bypass system blood tubing set
BO-RF32 RotaFlow
DATASCOPE CORP.
BO-T 39102
Not in Commercial Distribution

  • 00607567206793 ()
701064307

  • Cardiopulmonary bypass system blood tubing set
No Description
DATASCOPE CORP.
BO-T 20208
Not in Commercial Distribution

  • 00607567206557 ()
701067396

  • Cardiopulmonary bypass system blood tubing set
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