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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PXP Control Module
Thermogenesis Corp.
80065
In Commercial Distribution

  • 00886368000629 ()
  • 00886368000636 ()


  • Blood centrifugation system containment kit
No Description
Thermogenesis Corp.
8-5144
In Commercial Distribution

  • 00886368000568 ()
8-5144

  • Cryobiological storage container
Thermogenesis Start Up Accessory Kit, AXP
Thermogenesis Corp.
8-5100
In Commercial Distribution

  • 00886368000544 ()


  • Blood centrifugation system containment kit
AXP Accessory
Thermogenesis Corp.
8-5148
In Commercial Distribution

  • 00886368000537 ()
8-5148

  • Cryobiological storage container
AXP Accessory
Thermogenesis Corp.
8-5104
In Commercial Distribution

  • 00886368000520 ()
8-5104

  • Cryobiological storage container
AXP Accessory
Thermogenesis Corp.
7-00-288
In Commercial Distribution

  • 00886368000513 ()
7-00-288

  • Cryobiological storage container
No Description
Thermogenesis Corp.
8-5114
In Commercial Distribution

  • 00886368000445 ()
8-5114

  • Cryobiological storage container
No Description
Thermogenesis Corp.
8-5155
In Commercial Distribution

  • 00886368000438 ()
8-5155

  • Cryobiological storage container
No Description
Thermogenesis Corp.
8-5113
In Commercial Distribution

  • 00886368000421 ()
8-5113

  • Cryobiological storage container
No Description
Thermogenesis Corp.
8-5112
In Commercial Distribution

  • 00886368000414 ()
8-5112

  • Cryobiological storage container
No Description
Thermogenesis Corp.
8-5105
In Commercial Distribution

  • 00886368000407 ()
8-5105

  • Cryobiological storage container
Start-up kit for the AXP System
Thermogenesis Corp.
8-5100
In Commercial Distribution

  • 00886368000377 ()
8-5100

  • Cryobiological storage container
Cord blood processing system docking station
Thermogenesis Corp.
8-5103
In Commercial Distribution

  • 00886368000360 ()
  • 10886368000367 ()
8-5103

  • Cryobiological storage container
Cord blood processing system
Thermogenesis Corp.
8-5102
In Commercial Distribution

  • 00886368000346 ()
  • 10886368000343 ()
8-5102

  • Cryobiological storage container
Utilized for quality control testing of the AXP Device.
Thermogenesis Corp.
70176
In Commercial Distribution

  • 20886368000326 ()
  • 10886368000329 ()
  • 00886368000322 ()
8-5110

  • Cryobiological storage container
Cord blood processing system and storage container
Thermogenesis Corp.
8-5101
In Commercial Distribution

  • 10886368000305 ()
  • 00886368000308 ()


  • Cryobiological storage container
Freezing Bag Set
Thermogenesis Corp.
80135
In Commercial Distribution

  • 00886368000285 ()
  • 00886368000292 ()
80135

  • Blood centrifugation system containment kit
PXP-LAVARE Docking Station, packaged
Thermogenesis Corp.
80122
In Commercial Distribution

  • 00886368000223 ()
  • 00886368000162 ()


  • Blood centrifugation system containment kit
PXP-LAVARE Control Module, packaged
Thermogenesis Corp.
80121
In Commercial Distribution

  • 00886368000216 ()
  • 00886368000179 ()


  • Blood centrifugation system containment kit
PXP-LAVARE Disposable Cartridge
Thermogenesis Corp.
80120
In Commercial Distribution

  • 00886368000209 ()
  • 00886368000155 ()


  • Blood centrifugation system containment kit
PXP-LAVARE Disposable Cartridge
Thermogenesis Corp.
80118
In Commercial Distribution

  • 00886368000193 ()
  • 00886368000155 ()


  • Blood centrifugation system containment kit
PXP-LAVARE Disposable Cartridge
Thermogenesis Corp.
80118
In Commercial Distribution

  • 00886368000186 ()
  • 00886368000155 ()


  • Blood centrifugation system containment kit
PXP-1000 Disposable Cartridge
Thermogenesis Corp.
80102
In Commercial Distribution

  • 00886368000124 ()


  • Blood centrifugation system containment kit
PXP-1000 Disposable Cartridge
Thermogenesis Corp.
80102
In Commercial Distribution

  • 00886368000087 ()
  • 00886368000117 ()


  • Blood centrifugation system containment kit
PXP-1000 Disposable Cartridge
Thermogenesis Corp.
80101
In Commercial Distribution

  • 00886368000100 ()
  • 00886368000087 ()


  • Blood centrifugation system containment kit
PXP-1000 Disposable Cartridge
Thermogenesis Corp.
80100
In Commercial Distribution

  • 00886368000094 ()
  • 00886368000087 ()


  • Blood centrifugation system containment kit
PXP-1000 Docking Station
Thermogenesis Corp.
80103
In Commercial Distribution

  • 00886368000070 ()
  • 00886368000063 ()


  • Blood centrifugation system containment kit
PXP-1000 Control Module
Thermogenesis Corp.
80104
In Commercial Distribution

  • 00886368000056 ()
  • 00886368000049 ()


  • Blood centrifugation system containment kit
AXP II Refurbished Device
Thermogenesis Corp.
80056-RFB
In Commercial Distribution

  • 00886368000612 ()
  • 00886368000001 ()
80056-RFB

  • Blood centrifugation system containment kit
Persona™ Plasma Pooling Bottles
HAEMONETICS CORPORATION
0697S-00
In Commercial Distribution

  • 30812747019228 ()

  • Total Volume: 1200 Milliliter


  • Apheresis system tubing set
MultiPlasma Sets
TERUMO BCT, INC.
80700
Not in Commercial Distribution

  • 05020583807006 ()
  • 35020583807007 ()


  • Blood transfer set
Disposable Tubing Sets
TERUMO BCT, INC.
80340
Not in Commercial Distribution

  • 05020583803404 ()
  • 35020583803405 ()


  • Blood transfer set
Blood separation tube for PRFM
Factor Medical, Inc.
0364
In Commercial Distribution

  • 00851802007120 ()

  • Total Volume: 10 Milliliter
0364

  • Haematological concentrate system preparation kit, platelet concentration
Laparoscopic Dual Flexible Applicator
Ethicon Inc.
VSTL45
In Commercial Distribution

  • 30705031462728 ()
  • 10705031462724 ()
  • 20705031462721 ()
VSTL45

  • Haematological concentrate/haemostatic agent applicator cannula, endoscopic, single-use
Laparoscopic Dual Rigid Applicator
Ethicon Inc.
VSTL35
In Commercial Distribution

  • 20705031462578 ()
  • 10705031462571 ()
  • 30705031462575 ()
VSTL35

  • Haematological concentrate/haemostatic agent applicator cannula, endoscopic, single-use
Rigid, Airless Spray Accessory
Ethicon Inc.
3922S
Not in Commercial Distribution

  • 20705031240466 ()
  • 10705031240469 ()
  • 30705031240463 ()
3922S

  • Haematological concentrate/haemostatic agent applicator cannula, endoscopic, single-use
Evicel Airless Spray Accessory
Ethicon Inc.
3921S
Not in Commercial Distribution

  • 20705031230139 ()
  • 10705031230132 ()
  • 30705031230136 ()
3921S

  • Haematological concentrate/haemostatic agent applicator cannula, open-surgery
discovery® pearl bracket with hook, - 7° Torque, 0° Angulation for tooth 24, McLaughlin-Bennett-Trevisi** 22
DENTAURUM GmbH & Co.KG
722-742-24
In Commercial Distribution

  • J011722742240 ()


  • Orthodontic bracket, ceramic
discovery® pearl bracket with hook, - 7° Torque, 0° Angulation for tooth 24, Roth 22
DENTAURUM GmbH & Co.KG
722-741-24
In Commercial Distribution

  • J011722741240 ()


  • Orthodontic bracket, ceramic
discovery® pearl bracket with hook, - 7° Torque, 0° Angulation for tooth 24, Roth 18
DENTAURUM GmbH & Co.KG
718-741-24
In Commercial Distribution

  • J011718741240 ()


  • Orthodontic bracket, ceramic
discovery® pearl bracket with hook, - 7° Torque, 0° Angulation for tooth 24, McLaughlin-Bennett-Trevisi** 18
DENTAURUM GmbH & Co.KG
718-742-24
In Commercial Distribution

  • J011718742240 ()


  • Orthodontic bracket, ceramic
Curaplex Laryngoscope Set, Blue CASE incl Mac 2-4, Miller 0, 2, 3 and MED Handle
BOUND TREE MEDICAL, LLC
GP126
In Commercial Distribution

  • 00815277029988 ()
GP126

  • First aid kit, non-medicated, single-use
X-MESH EXPANDABLE CAGE SYSTEM EXPANDABLE VERTEBRAL BODY REPLACEMENT, ANTERIOR, LARGE 65 - 90mm, 0/24 DEGREES
Medos International Sàrl
188912565
Not in Commercial Distribution

  • 10705034160580 ()
188912565

  • Metallic spinal interbody fusion cage
X-MESH EXPANDABLE CAGE SYSTEM EXPANDABLE VERTEBRAL BODY REPLACEMENT, ANTERIOR, LARGE 51 - 71mm, 0/24 DEGREES
Medos International Sàrl
188912551
Not in Commercial Distribution

  • 10705034160573 ()
188912551

  • Metallic spinal interbody fusion cage
X-MESH EXPANDABLE CAGE SYSTEM EXPANDABLE VERTEBRAL BODY REPLACEMENT, ANTERIOR, LARGE 40 - 56mm, 0/24 DEGREES
Medos International Sàrl
188912540
Not in Commercial Distribution

  • 10705034160566 ()
188912540

  • Metallic spinal interbody fusion cage
TG Ab QC Kit - Atellica IM - CLT 2 x 3 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
10995465
In Commercial Distribution

  • 00630414597928 ()
10995465

  • Thyroglobulin antibody IVD, control
TG Ab - Atellica IM - Master Curve Material Kit 6 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995464
In Commercial Distribution

  • 00630414597911 ()
10995464

  • Thyroglobulin antibody IVD, control
No Description
MAXTEC, LLC
R500P21
Not in Commercial Distribution

  • 10817770020810 ()


  • Exhaled-gas oesophageal intubation detector
Cannula, 24-Hole Infiltration, specify length, diameter, tip shape and handle/hub
The Wells Johnson Company
20124800
In Commercial Distribution

  • B458201248000 ()
20-1248-00

  • Liposuction system cannula, reusable
Brush for composite
TOKUYAMA DENTAL CORPORATION
10762
In Commercial Distribution

  • 04548190107629 ()
  • 94548190107622 ()


  • Dental material application tool, reusable
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