Company Name Brand Name GMDN Term 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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No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3100ZP
In Commercial Distribution

  • 00840682123754 ()


  • Stationary gamma camera system
  • Full-body CT system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3906AL
In Commercial Distribution

  • 00840682123778 ()


  • Full-body CT system
  • Stationary gamma camera system
No Description
Hangwei GE Medical Systems Co., Ltd.
H2401DS
In Commercial Distribution

  • 00840682154338 ()


  • Stationary gamma camera system
  • Full-body CT system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H2401JF
In Commercial Distribution

  • 00840682123761 ()


  • Stationary gamma camera system
Each Vascular Solutions D-Stat® flowable hemostat (D-Stat) includes the following components: Thrombin vial (5,000 units); Collagen (200mg), contained in 10ml syringe with attached mixing luer; Diluent vial (5ml); Mixing accessories (10ml syringe and needleless, non-coring vial access device); Applicator tips: (1) small bore tip, (1) 20-Gauge, 2.75" needle. The thrombin is a protein substance produced through a conversion reaction in which prothrombin of bovine origin is activated by tissue thromboplastin of bovine-origin in the presence of calcium chloride. It is supplied as a sterile powder that has been freeze-dried in the final container. Also contained in the thrombin vial are mannitol and sodium chloride. Mannitol is included to make the dried product friable and more readily soluble. The material contains no preservative and has been chromatographically purified. Thrombin requires no intermediate physiological agent for its reaction. It converts fibrinogen directly to fibrin. The collagen is a soft, white, pliable, absorbent hemostatic agent derived from purified bovine deep flexor tendon. It is prepared in a loose fibrous form. Collagen attracts platelets that adhere to the fibrils and undergo the release phenomenon to trigger aggregation of platelets into thrombi in the interstices of the fibrous mass. The collagen provides a three-dimensional matrix for additional strengthening of the clot. The effect on platelet adhesion and aggregation is not inhibited by heparin in vitro. The diluent is a sterile solution of calcium chloride and water, buffered with tromethamine (TRIS). Using the mixing accessories, both the thrombin and collagen are reconstituted with the diluent prior to use. The hemostat is delivered to the intended treatment site using the provided applicator tips. Hemostasis is achieved by the physiological coagulation-inducing properties of the D-Stat. The D-Stat is biocompatible, non-pyrogenic, and intended to be left in situ.
Vascular Solutions, Inc.
4000
In Commercial Distribution

  • M20640000 ()
  • M20640001 ()


  • Collagen haemostatic agent, non-antimicrobial
Polypropylene
Innovasis, Inc.
LS-459
In Commercial Distribution

  • M711LS4590 ()
LS-459

  • Bone graft packing block
No Description
I.C. MEDICAL, INC.
ICM-460-0000
In Commercial Distribution

  • 00817688021896 ()


  • Surgical plume evacuation system
No Description
I.C. MEDICAL, INC.
ICM-450-0000
In Commercial Distribution

  • 00817688021889 ()


  • Surgical plume evacuation system
No Description
I.C. MEDICAL, INC.
ICM-470-0004
In Commercial Distribution

  • 00817688021865 ()


  • Surgical plume evacuation system
No Description
I.C. MEDICAL, INC.
ICM-470-0000
In Commercial Distribution

  • 00817688021858 ()


  • Surgical plume evacuation system
No Description
I.C. MEDICAL, INC.
ICM-360-0001
In Commercial Distribution

  • 00817688021834 ()


  • Surgical plume evacuation system
No Description
I.C. MEDICAL, INC.
ICM-360-0000
In Commercial Distribution

  • 00817688021827 ()


  • Surgical plume evacuation system
CRYSTAL® PACKING BLOCK
SPINAL ELEMENTS, INC.
20021-000
In Commercial Distribution

  • 00840606135191 ()


  • Bone graft packing block
CRYSTAL® PACKING INSTRUMENT
SPINAL ELEMENTS, INC.
20019-000
In Commercial Distribution

  • 00840606135177 ()


  • Bone graft packing block
CryoTip
FUJIFILM IRVINE SCIENTIFIC, INC.
40709-Pack
In Commercial Distribution

  • 00893727002118 ()
  • 10893727002115 ()
40709

  • Assisted reproduction cryotube
Rotation Block
SEASPINE ORTHOPEDICS CORPORATION
10-40-0330
In Commercial Distribution

  • 10889981106638 ()
10-40-0330

  • Bone graft packing block
CorMatrix Cor PATCH is intended for epicardial tissue support and repair.
CORMATRIX CARDIOVASCULAR, INC.
CMCP5P-710
In Commercial Distribution

  • 00850003965017 ()

  • Width: 10 Centimeter
  • Length: 7 Centimeter


  • Cardiovascular patch, animal-derived
CorMatrix Cor PATCH is intended for epicardial tissue support and repair.
CORMATRIX CARDIOVASCULAR, INC.
CMCP5P-055
In Commercial Distribution

  • 00850003965000 ()

  • Length: 5 Centimeter


  • Cardiovascular patch, animal-derived
Gamma Camera System
Ddd-Diagnostic A/S
CorCam Gamma Camera System
In Commercial Distribution

  • 05711665002005 ()

  • Weight: 815 Kilogram
  • Height: 150 Centimeter
  • Depth: 150 Centimeter
  • Width: 284 Centimeter
9COR2370

  • Stationary gamma camera system
No Description
Synapse Biomedical, Inc.
22-0004
In Commercial Distribution

  • 00852184003342 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system
No Description
Synapse Biomedical, Inc.
22-0022
In Commercial Distribution

  • 00852184003403 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system
No Description
Synapse Biomedical, Inc.
22-0030
In Commercial Distribution

  • 00852184003434 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system
No Description
Synapse Biomedical, Inc.
22-0029
In Commercial Distribution

  • 00852184003427 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system
Smoke Evacuation Unit
Buffalo Filter
220V
In Commercial Distribution

  • 00815198012410 ()
60-8585-230

  • Surgical plume evacuation system
Smoke Evacuation Unit
Buffalo Filter
120V
In Commercial Distribution

  • 00815198012403 ()
60-8585-120

  • Surgical plume evacuation system
No Description
I.C. MEDICAL, INC.
2220
In Commercial Distribution

  • 00817688021704 ()
ICM-000-0421

  • Surgical plume evacuation system
No Description
I.C. MEDICAL, INC.
ICM-000-0025
In Commercial Distribution

  • 00817688021698 ()


  • Surgical plume evacuation system
No Description
Hertart ApS
16106
In Commercial Distribution

  • 27350025914606 ()
  • 17350025914609 ()
  • 07350025914602 ()


  • Assisted reproduction centrifuge tube
No Description
Hertart ApS
16105
In Commercial Distribution

  • 27350025914590 ()
  • 17350025914593 ()
  • 07350025914596 ()


  • Assisted reproduction centrifuge tube
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-42-1803
In Commercial Distribution

  • 09348215054755 ()


  • Uncoated femoral stem prosthesis, one-piece
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-42-1603
In Commercial Distribution

  • 09348215054748 ()


  • Uncoated femoral stem prosthesis, one-piece
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-42-1503
In Commercial Distribution

  • 09348215054731 ()


  • Uncoated femoral stem prosthesis, one-piece
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-42-1403
In Commercial Distribution

  • 09348215054724 ()


  • Uncoated femoral stem prosthesis, one-piece
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-42-1303
In Commercial Distribution

  • 09348215054717 ()


  • Uncoated femoral stem prosthesis, one-piece
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-42-1203
In Commercial Distribution

  • 09348215054700 ()


  • Uncoated femoral stem prosthesis, one-piece
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-42-1103
In Commercial Distribution

  • 09348215054694 ()


  • Uncoated femoral stem prosthesis, one-piece
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-42-1003
In Commercial Distribution

  • 09348215054687 ()


  • Uncoated femoral stem prosthesis, one-piece
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-42-0903
In Commercial Distribution

  • 09348215054670 ()


  • Uncoated femoral stem prosthesis, one-piece
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-42-0803
In Commercial Distribution

  • 09348215054663 ()


  • Uncoated femoral stem prosthesis, one-piece
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-42-1802
In Commercial Distribution

  • 09348215054656 ()


  • Uncoated femoral stem prosthesis, one-piece
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-42-1602
In Commercial Distribution

  • 09348215054649 ()


  • Uncoated femoral stem prosthesis, one-piece
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-42-1502
In Commercial Distribution

  • 09348215054632 ()


  • Uncoated femoral stem prosthesis, one-piece
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-42-1402
In Commercial Distribution

  • 09348215054625 ()


  • Uncoated femoral stem prosthesis, one-piece
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-42-1302
In Commercial Distribution

  • 09348215054618 ()


  • Uncoated femoral stem prosthesis, one-piece
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-42-1202
In Commercial Distribution

  • 09348215054601 ()


  • Uncoated femoral stem prosthesis, one-piece
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-42-1102
In Commercial Distribution

  • 09348215054595 ()


  • Uncoated femoral stem prosthesis, one-piece
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-42-1002
In Commercial Distribution

  • 09348215054588 ()


  • Uncoated femoral stem prosthesis, one-piece
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-42-0902
In Commercial Distribution

  • 09348215054571 ()


  • Uncoated femoral stem prosthesis, one-piece
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-42-0802
In Commercial Distribution

  • 09348215054564 ()


  • Uncoated femoral stem prosthesis, one-piece
Gamma Camera System
Ddd-Diagnostic A/S
CardioMD Gamma Camera System
Not in Commercial Distribution

  • 05711665002029 ()

  • Width: 284 Centimeter
  • Depth: 150 Centimeter
  • Height: 150 Centimeter
  • Weight: 815 Kilogram
9PMS3060

  • Stationary gamma camera system
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