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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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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
The TCDB40 Wafer Assembly consists of a copper wafer and plastic holder. The plastic holder is color coded to assist the operator with proper placement/insertion. The wafer assembly is placed in the TCDB40 Sterile Tube Welding device prior to the weld process. The copper wafer is separated from the plastic holder during the welding process and after welding is completed both the plastic holder and the copper wafer are removed from the device and discarded. The wafers are single use only and cannot be reused. The TCDB40 Sterile Tube Welding device will not operate without a wafer assembly inserted and will not operate with a used a wafer. The TCDB40 wafer assemblies are packaged in 8 plastic trays. Each tray has 25 individual wafer assemblies. Each box referred to as a case has a total of 200 individual TCDB40 wafer assemblies.
GENESIS BPS LLC
TCD B40
In Commercial Distribution

  • 10866305000278 ()
  • 00866305000271 ()
480-B40-00-2038

  • Laboratory tubing welder
The Blade Module consists of a stainless steel blade that cuts the PVC tube segments. The Blade Module is designed with a built in service meter to record the number of welds performed on the device. This feature monitors the usage endured by the Blade Module. The operator is notified when the Blade Module requires replacement. If the operator fails to respond to the warning message and replace the Blade Module the Genesis Rapid Weld STW will not operate once the Blade Module weld cycle limit is reached. Operation will resume once a replacement Blade Module is installed.
GENESIS BPS LLC
GRW-430
In Commercial Distribution

  • 10866305000254 ()
  • 00866305000257 ()
480-RW-2478-03

  • Laboratory tubing welder
The Blade Module consists of a stainless steel blade that cuts the PVC tube segments. The Blade Module is designed with a built in service meter to record the number of welds performed on the device. This feature monitors the usage endured by the Blade Module. The operator is notified when the Blade Module requires replacement. If the operator fails to respond to the warning message and replace the Blade Module the Genesis Rapid Weld STW will not operate once the Blade Module weld cycle limit is reached. Operation will resume once a replacement Blade Module is installed.
GENESIS BPS LLC
GRW-430
In Commercial Distribution

  • 10866305000247 ()
  • 00866305000240 ()
480-RW-2478-02

  • Laboratory tubing welder
The Blade Module consists of a stainless steel blade that cuts the PVC tube segments. The Blade Module is designed with a built in service meter to record the number of welds performed on the device. This feature monitors the usage endured by the Blade Module. The operator is notified when the Blade Module requires replacement. If the operator fails to respond to the warning message and replace the Blade Module the Genesis RapidWeld STW, Model GRW-430 will not operate once the Blade Module weld cycle limit is reached. Operation will resume once a replacement Blade Module is installed.
GENESIS BPS LLC
GRW-430
In Commercial Distribution

  • 10866305000230 ()
  • 00866305000233 ()
480-RW-2478-01

  • Laboratory tubing welder
The TCD B40 Wafer Assembly consists of a copper wafer and a plastic holder. The plastic holder is color coded to assist the operator with proper placement/insertion.The wafer assembly is placed in the device prior to the weld process. During the welding process the copper wafer is separated from the plastic holder, and after welding is completed, both the holder and wafer are removed from the device and discarded. The wafers are one-time use only and cannot be reused. The TCD B40 device will not operate without a wafer assembly inserted and will not operate with a used wafer. The TCD B40 wafer assemblies are packaged in boxes containing 240 wafer assemblies in each box referred to as a case.
GENESIS BPS LLC
TCD B40
In Commercial Distribution

  • 10866305000223 ()
  • 00866305000226 ()
480-B40-00-1274

  • Laboratory tubing welder
Blood mixing and weighing device
Transmed Medizintechnik GmbH & Co. KG
TRANSWAAG PRO
In Commercial Distribution

  • 04028339620139 ()
97.8700.105

  • Blood weighing scale
0625Q-00 Plasma Bowl
HAEMONETICS CORPORATION
0625Q-00
In Commercial Distribution

  • 30812747019730 ()
  • 10812747019736 ()


  • Apheresis system tubing set
0625Q-00 Plasma Bowl
HAEMONETICS CORPORATION
0625Q-00
In Commercial Distribution

  • 30812747019334 ()
  • 10812747019330 ()


  • Apheresis system tubing set
RBCF-2P SET
HAEMONETICS CORPORATION
0822F-2P
In Commercial Distribution

  • 30812747013509 ()
  • 10812747013505 ()


  • Apheresis system tubing set
REDCELLS & PLASMA DISPOSABLESET
HAEMONETICS CORPORATION
00822-2P
In Commercial Distribution

  • 30812747013493 ()
  • 10812747013499 ()

  • Total Volume: 1000 Milliliter
  • Total Volume: 275 Milliliter
  • Total Volume: 600 Milliliter


  • Apheresis system tubing set
TWO UNIT RED CELLS DISPOSABLE SETS
HAEMONETICS CORPORATION
00832-00
In Commercial Distribution

  • 30812747013486 ()
  • 10812747013482 ()

  • Total Volume: 600 Milliliter
  • Total Volume: 1000 Milliliter
  • Total Volume: 275 Milliliter


  • Apheresis system tubing set
REDCELLS & PLASMA DISPOSABLESET
HAEMONETICS CORPORATION
00822-00
In Commercial Distribution

  • 10812747013475 ()
  • 30812747013479 ()

  • Total Volume: 1000 Milliliter
  • Total Volume: 275 Milliliter
  • Total Volume: 600 Milliliter


  • Apheresis system tubing set
MCS+ SDP/PLP CON FIL,994CF-CPP
HAEMONETICS CORPORATION
994CF-CPP
In Commercial Distribution

  • 10812747012270 ()
  • 30812747012274 ()

  • Total Volume: 1000 Milliliter
  • Total Volume: 225 Milliliter


  • Apheresis system tubing set
MCS+ SDP/PLP W/SALINE,LN 994
HAEMONETICS CORPORATION
00994-00
In Commercial Distribution

  • 30812747012090 ()
  • 10812747012096 ()

  • Total Volume: 1000 Milliliter
  • Total Volume: 600 Milliliter
  • Total Volume: 50 Milliliter


  • Apheresis system tubing set
PLS Harness Set
HAEMONETICS CORPORATION
00620-CP
In Commercial Distribution

  • 30812747011765 ()
  • 10812747011761 ()


  • Apheresis system tubing set
PLS Harness Set
HAEMONETICS CORPORATION
00620-00
Not in Commercial Distribution

  • 30812747011758 ()
  • 10812747011754 ()


  • Apheresis system tubing set
PLS Saline Adaptor
HAEMONETICS CORPORATION
00695-00
In Commercial Distribution

  • 30812747011734 ()
  • 10812747011730 ()


  • Apheresis system tubing set
PLS Bag w/Vac Sampling
HAEMONETICS CORPORATION
SC690-00
In Commercial Distribution

  • 30812747011710 ()
  • 10812747011716 ()


  • Apheresis system tubing set
PLS Bag w/NaCl Spike
HAEMONETICS CORPORATION
00692-00
In Commercial Distribution

  • 30812747011703 ()
  • 10812747011709 ()

  • Total Volume: 1000 Milliliter


  • Apheresis system tubing set
PLS Bag
HAEMONETICS CORPORATION
00690-00
In Commercial Distribution

  • 30812747011697 ()
  • 10812747011693 ()

  • Total Volume: 1000 Milliliter


  • Apheresis system tubing set
BMB PLS Bowls
HAEMONETICS CORPORATION
0625B-00
In Commercial Distribution

  • 30812747011680 ()
  • 10812747011686 ()

  • Total Volume: 275 Milliliter


  • Apheresis system tubing set
Typesafe Segment Piercing Device
TYPENEX MEDICAL LLC
4R4750
In Commercial Distribution

  • 00812269031295 ()
  • 10812269031285 ()
  • 00812269031288 ()


  • Blood donor bag segment sampling IVD
Typesafe Segment Piercing Device
TYPENEX MEDICAL LLC
TS500
In Commercial Distribution

  • 20812269031275 ()
  • 10812269031278 ()
  • 00812269031271 ()


  • Blood donor bag segment sampling IVD
Typesafe 2.0 - Quantity 1000
TYPENEX MEDICAL LLC
SP0201QM
In Commercial Distribution

  • 00812269031264 ()
  • 10812269031254 ()
  • 00812269031257 ()


  • Blood donor bag segment sampling IVD
Typesafe 2.0 - Quantity 500
TYPENEX MEDICAL LLC
SP0201QD
In Commercial Distribution

  • 00812269031240 ()
  • 10812269031230 ()
  • 00812269031233 ()


  • Blood donor bag segment sampling IVD
PLS HARNESS SET
HAEMONETICS CORPORATION
00620-CC
In Commercial Distribution

  • 30812747019341 ()
  • 10812747019347 ()


  • Apheresis system tubing set
PLS HARNESS SET
HAEMONETICS CORPORATION
00620-CP-CC
In Commercial Distribution

  • 30812747019273 ()
  • 10812747019279 ()


  • Apheresis system tubing set
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