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The #1-rated insulin pump is now integrated with the #1-rated Continuous Glucose Monitoring brand that set the standard for accuracy and performance in sensor-augmented pumps. The t:slim G4 Pump is the only pump that conveniently combines CGM graphs and trend information with current insulin delivery together on a single color touch screen to help you make more informed decisions.
Tandem Diabetes Care, Inc.
007526
In Commercial Distribution
- 00852162004415 ()
- 10852162004412 ()
- Total Volume: 3 Milliliter
- Ambulatory insulin infusion pump reservoir
The #1-rated insulin pump is now integrated with the #1-rated Continuous Glucose Monitoring brand that set the standard for accuracy and performance in sensor-augmented pumps. The t:slim G4 Pump is the only pump that conveniently combines CGM graphs and trend information with current insulin delivery together on a single color touch screen to help you make more informed decisions.
Tandem Diabetes Care, Inc.
006194
In Commercial Distribution
- 00852162004408 ()
- Ambulatory insulin infusion pump/blood glucose analyser system
The LeukoStrat CDx FLT3 Mutation Assay is a PCR-based in vitro diagnostic test designed to detect internal tandem duplication (ITD) and tyrosine kinase domain (TKD) mutations D835 and I836 in the FLT3 gene in genomic DNA extracted from mononuclear cells obtained from peripheral blood or bone marrow aspirates of patients diagnosed with acute myelogenous leukemia (AML).
INVIVOSCRIBE, INC.
850052003739
Not in Commercial Distribution
- 00850052003739 ()
K4120361
- Acute myeloid leukaemia (AML) genetic mutation IVD, kit, nucleic acid technique (NAT)
The intended purpose is for certified surgeons, to conduct the surgical procedure for Abutment Extraction, facilitate removal of Abutment and Abutment Screw within an OPRA™ Implant System in a patient. Consist of instruments:
Clamp head
Clamp head Pusher
Clamp head Screw
Pressure Peg Hex
T-Handle 5 mm
Spanner 14 mm
Spanner 12 mm
Spanner 10 mm
Integrum AB
2531
In Commercial Distribution
- 07340152101976 ()
- Internal-external leg prosthesis osseointegration bar
The LeukoStrat CDx FLT3 Mutation Assay is a PCR-based in vitro diagnostic test designed to detect internal tandem duplication (ITD) and tyrosine kinase domain (TKD) mutations D835 and I836 in the FLT3 gene in genomic DNA extracted from mononuclear cells obtained from peripheral blood or bone marrow aspirates of patients diagnosed with acute myelogenous leukemia (AML).
INVIVOSCRIBE, INC.
00810022732571
In Commercial Distribution
- 00810022732571 ()
K4120361
- Acute myeloid leukaemia (AML) genetic mutation IVD, kit, nucleic acid technique (NAT)
The VASCADE VCS is intended to seal femoral vessel puncture sites at the completion of catheter-based procedures. The system is designed to deliver a resorbable Collagen Patch, extra-vascularly, at the vessel puncture site to achieve hemostasis. For use in 6F & 7F introducer sheaths; overall length of the sheath (including the hub) needs to be less than 15cm.
CARDIVA MEDICAL, INC.
700-580I
In Commercial Distribution
- M729700580I1 ()
- M729700580I0 ()
- M729700580I3 ()
- Catheter Gauge: 7 French
- Catheter Gauge: 6 French
- Femoral artery closure plug/patch, collagen
The VASCADE VCS is intended to seal femoral vessel puncture sites at the completion of catheter-based procedures. The system is designed to deliver a resorbable Collagen Patch, extra-vascularly, at the vessel puncture site to achieve hemostasis. For use in 5F introducer sheaths; overall length of the sheath (including the hub) needs to be less than 15cm.
CARDIVA MEDICAL, INC.
700-500DX
In Commercial Distribution
- M729700500DX1 ()
- M729700500DX0 ()
- M729700500DX3 ()
- Catheter Gauge: 5 French
- Femoral artery closure plug/patch, collagen
AVG 502AG27 US
MEDTRONIC, INC.
502AG27
In Commercial Distribution
- 00763000199005 ()
- Lumen/Inner Diameter: 27.0 Millimeter
- Aortic bi-leaflet mechanical heart valve prosthesis/biologic-polymer aorta graft
AVG 502AG25 US
MEDTRONIC, INC.
502AG25
In Commercial Distribution
- 00763000198992 ()
- Lumen/Inner Diameter: 25.0 Millimeter
- Aortic bi-leaflet mechanical heart valve prosthesis/biologic-polymer aorta graft
AVG 502AG23 US
MEDTRONIC, INC.
502AG23
In Commercial Distribution
- 00763000198985 ()
- Lumen/Inner Diameter: 23.0 Millimeter
- Aortic bi-leaflet mechanical heart valve prosthesis/biologic-polymer aorta graft