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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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DEPTHALON - 00650551001386

SEEG, 16 CONTACT, 6-2MM & 10-0.5MM CONTACT, NON-STANDARD SPACING AND 27MM BETWEEN CONTACT 9&10 WITH 6-2MM BLANK CONTACTS, 60MM RECORDING DEPTH, MINI CONNECTOR, REMOVABLE STYLET, 2.4MM DRILL
PMT CORPORATION
2102-16-178
In Commercial Distribution

  • 00650551001386 ()


  • Depth electrode

DEPTHALON - 00650551001201

SEEG, 14 CONTACT, 2MM CONTACT SIZE, 5.33MM CTC SPACING, 71.3MM RECORDING DEPTH, REMOVABLE STYLET, 2.4MM DRILL
PMT CORPORATION
2102-14-147
In Commercial Distribution

  • 00650551001201 ()


  • Depth electrode

DEPTHALON - 00650551001171

SEEG, 16 CONTACT, 2MM CONTACT SIZE, 6.53MM CTC SPACING, 100MM RECORDING DEPTH, REMOVABLE STYLET, 2.1MM DRILL
PMT CORPORATION
2102-16-156
In Commercial Distribution

  • 00650551001171 ()


  • Depth electrode

DEPTHALON - 00650551001140

SEEG, 16 CONTACT, 4 X 2MM & 12 X 0.5MM CONTACT SIZE, 41MM RECORDING DEPTH, REMOVABLE STYLET, 2.4MM DRILL. NON-STERILE
PMT CORPORATION
2102-16-177-NS
In Commercial Distribution

  • 00650551001140 ()


  • Depth electrode

DEPTHALON - 00650551000860

SEEG, 16 CONTACT, 4 X 2MM & 12 X 0.5MM CONTACT SIZE, 48MM RECORDING DEPTH, MINI CONNECTOR, REMOVABLE STYLET, 2.4MM DRILL, NON-STERILE
PMT CORPORATION
2102-16-176-NS
In Commercial Distribution

  • 00650551000860 ()


  • Depth electrode

DEPTHALON - 00650551000853

SEEG, 16 CONTACT, 4 X 2MM & 12 X 0.5MM CONTACT SIZE, 44.5MM RECORDING DEPTH, MINI CONNECTOR, REMOVABLE STYLET, 2.4MM DRILL, NON-STERILE
PMT CORPORATION
2102-16-175-NS
In Commercial Distribution

  • 00650551000853 ()


  • Depth electrode

DEPTHALON - 00650551000471

MICROWIRE DEPTHALON ELECTRODE, 1.5MM CONTACTS MARCO CONTACT DIA., 8 MACRO CONTACTS, 16 MICROWIRE CONTACTS, 51.1MM RECORDING LENGTH, MINI CONNECTOR, NON-STERILE
PMT CORPORATION
2104-08-16-006-NS
In Commercial Distribution

  • 00650551000471 ()


  • Depth electrode

DEPTHALON - 00650551000426

SEEG, 16 CONTACT, 2MM CONTACT SIZE, 6MM CTC SPACING, 92MM RECORDING DEPTH, REMOVABLE STYLET, 2.4MM DRILL
PMT CORPORATION
2102-16-149
In Commercial Distribution

  • 00650551000426 ()


  • Depth electrode

DEPTHALON - 00650551000419

SEEG, 16 CONTACT, 4 X 2MM & 12 X 0.5MM CONTACT SIZE, 41MM RECORDING DEPTH, REMOVABLE STYLET, 2.4MM DRILL
PMT CORPORATION
2102-16-177
In Commercial Distribution

  • 00650551000419 ()


  • Depth electrode

DEPTHALON - 00650551000402

SEEG, 16 CONTACT, 4 X 2MM & 12 X 0.5MM CONTACT SIZE, 48MM RECORDING DEPTH, MINI CONNECTOR, REMOVABLE STYLET, 2.4MM DRILL
PMT CORPORATION
2102-16-176
In Commercial Distribution

  • 00650551000402 ()


  • Depth electrode

DEPTHALON - 00650551000396

SEEG, 16 CONTACT, 4 X 2MM & 12 X 0.5MM CONTACT SIZE, 44.5MM RECORDING DEPTH, MINI CONNECTOR, REMOVABLE STYLET, 2.4MM DRILL
PMT CORPORATION
2102-16-175
In Commercial Distribution

  • 00650551000396 ()


  • Depth electrode

DEPTHALON - 00650551000204

DEPTH ELECTRODE, PLATINUM, 4 CONTACT, 17MM RECORDING LENGTH, 5MM SPACING, MINI CONNECTOR
PMT CORPORATION
2102-04-003
In Commercial Distribution

  • 00650551000204 ()


  • Depth electrode

DEPTHALON - 00650551000150

MICROWIRE DEPTHALON ELECTRODE, 1MM BULLET TIP, 8 X 1.5MM CONTACTS MACRO CONTACTS, 32 X 40UM MICROWIRE CONTACTS, 39.5MM RECORDING LENGTH, 1.27MM DIA., MINI CONNECTOR
PMT CORPORATION
2104-09-32-001
In Commercial Distribution

  • 00650551000150 ()


  • Depth electrode

DEPTHALON - 00650551000143

MICROWIRE DEPTHALON ELECTRODE, 1MM BULLET TIP, 9 X 1.5MM CONTACTS MACRO CONTACTS, 32 X 40UM MICROWIRE CONTACTS, 42.5MM RECORDING LENGTH, 1.27MM DIA., MINI CONNECTOR
PMT CORPORATION
2104-10-32-002
In Commercial Distribution

  • 00650551000143 ()


  • Depth electrode

DEPTHALON - 00650551000136

MICROWIRE DEPTHALON ELECTRODE, 1MM BULLET TIP, 9 X 1.5MM CONTACTS MACRO CONTACTS, 32 X 40UM MICROWIRE CONTACTS, 50MM RECORDING LENGTH, 1.27MM DIA., MINI CONNECTOR
PMT CORPORATION
2104-10-32-001
In Commercial Distribution

  • 00650551000136 ()


  • Depth electrode

DEPTHALON - 00650551000129

MICROWIRE DEPTHALON ELECTRODE, 1MM BULLET TIP, 6 X 1.5MM CONTACTS MACRO CONTACTS, 57 X 40UM MICROWIRE CONTACTS, 54.25MM RECORDING LENGTH, 1.27MM DIA., MINI CONNECTOR
PMT CORPORATION
2104-07-57-012
In Commercial Distribution

  • 00650551000129 ()


  • Depth electrode

DEPTHALON - 00650551000112

MICROWIRE DEPTHALON ELECTRODE, 1MM BULLET TIP, 6 X 1.5MM CONTACTS MACRO CONTACTS, 57 X 40UM MICROWIRE CONTACTS, 51.25MM RECORDING LENGTH, 1.27MM DIA., MINI CONNECTOR
PMT CORPORATION
2104-08-57-011
In Commercial Distribution

  • 00650551000112 ()


  • Depth electrode

DEPTHALON - 00650551000105

MICROWIRE DEPTHALON ELECTRODE, 1MM BULLET TIP, 6 X 1.5MM CONTACTS MACRO CONTACTS, 57 X 40UM MICROWIRE CONTACTS, 49.25MM RECORDING LENGTH, 1.27MM DIA., MINI CONNECTOR
PMT CORPORATION
2104-07-57-010
In Commercial Distribution

  • 00650551000105 ()


  • Depth electrode

DEPTHALON - 00650551000099

MICROWIRE DEPTHALON ELECTRODE, 1MM BULLET TIP, 6 X 1.5MM CONTACTS MACRO CONTACTS, 57 X 40UM MICROWIRE CONTACTS, 46.25MM RECORDING LENGTH, 1.27MM DIA., MINI CONNECTOR
PMT CORPORATION
2104-07-57-009
In Commercial Distribution

  • 00650551000099 ()


  • Depth electrode

D750b - 00840682138758

No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
Gantry UPG
In Commercial Distribution

  • 00840682138758 ()


  • Stationary gamma camera system

D750b - 00840682138741

No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
Biopsy
In Commercial Distribution

  • 00840682138741 ()


  • Stationary gamma camera system

D750b - 00840682138697

No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
Gantry
In Commercial Distribution

  • 00840682138697 ()


  • Stationary gamma camera system

D670 Upgrade - 00840682123747

No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3100CF
In Commercial Distribution

  • 00840682123747 ()


  • Stationary gamma camera system
  • Full-body CT system

D670 Pro Upgrade - 00840682123754

No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3100ZP
In Commercial Distribution

  • 00840682123754 ()


  • Stationary gamma camera system
  • Full-body CT system

D670 CZT Upgrade - 00840682123778

No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3906AL
In Commercial Distribution

  • 00840682123778 ()


  • Full-body CT system
  • Stationary gamma camera system

D630 to D670 DR Upgrade - 00840682154338

No Description
Hangwei GE Medical Systems Co., Ltd.
H2401DS
In Commercial Distribution

  • 00840682154338 ()


  • Stationary gamma camera system
  • Full-body CT system

D630 to D670 DR Upgrade - 00195278794772

D630 to D670 DR NM GANTRY UPGRADE KIT
G E MEDICAL SYSTEMS ISRAEL LTD.
H3101RS
In Commercial Distribution

  • 00195278794772 ()
5953035

  • Stationary gamma camera system
  • Full-body CT system

D630 Upgrade - 00840682145503

B615 to D630 upgrade kits option with new ROTOR
Hangwei GE Medical Systems Co., Ltd.
H2401XF
In Commercial Distribution

  • 00840682145503 ()
H2401XF

  • Stationary gamma camera system

D630 Upgrade - 00840682123761

No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H2401JF
In Commercial Distribution

  • 00840682123761 ()


  • Stationary gamma camera system

D-Stat® Flowable Hemostat - M20640000

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

CxHA™ - M711LS4590

Polypropylene
Innovasis, Inc.
LS-459
In Commercial Distribution

  • M711LS4590 ()
LS-459

  • Bone graft packing block

Crystal Vision - 00817688021902

Crystal Vision Model 250D
I.C. MEDICAL, INC.
ICM-250-0000
In Commercial Distribution

  • 00817688021902 ()
ICM-250-0000

  • Surgical plume evacuation system

Crystal Vision - 00817688021896

No Description
I.C. MEDICAL, INC.
ICM-460-0000
In Commercial Distribution

  • 00817688021896 ()


  • Surgical plume evacuation system

Crystal Vision - 00817688021889

No Description
I.C. MEDICAL, INC.
ICM-450-0000
In Commercial Distribution

  • 00817688021889 ()


  • Surgical plume evacuation system

Crystal Vision - 00817688021865

No Description
I.C. MEDICAL, INC.
ICM-470-0004
In Commercial Distribution

  • 00817688021865 ()


  • Surgical plume evacuation system

Crystal Vision - 00817688021858

No Description
I.C. MEDICAL, INC.
ICM-470-0000
In Commercial Distribution

  • 00817688021858 ()


  • Surgical plume evacuation system

Crystal Vision - 00817688021834

No Description
I.C. MEDICAL, INC.
ICM-360-0001
In Commercial Distribution

  • 00817688021834 ()


  • Surgical plume evacuation system

Crystal Vision - 00817688021827

No Description
I.C. MEDICAL, INC.
ICM-360-0000
In Commercial Distribution

  • 00817688021827 ()


  • Surgical plume evacuation system

CryoTip® - 00893727002118

CryoTip
FUJIFILM IRVINE SCIENTIFIC, INC.
40709-Pack
In Commercial Distribution

  • 00893727002118 ()
  • 10893727002115 ()
40709

  • Assisted reproduction cryotube

Coral - 10889981106638

Rotation Block
SEASPINE ORTHOPEDICS CORPORATION
10-40-0330
In Commercial Distribution

  • 10889981106638 ()
10-40-0330

  • Bone graft packing block

CorMatrix(R) Cor(TM) PATCH Epicardial Patch, Five Pack, 7cm x 10cm - 00850003965017

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(R) Cor(TM) PATCH Epicardial Patch, Five Pack, 5cm x 5cm - 00850003965000

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

CorCam - 05711665002005

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

Connector Holder Kit - 00852184003342

No Description
Synapse Biomedical, Inc.
22-0004
In Commercial Distribution

  • 00852184003342 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

Clinician Crimp Tool - 00852184003403

No Description
Synapse Biomedical, Inc.
22-0022
In Commercial Distribution

  • 00852184003403 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

Clinician Connector Repair Parts Kit - 00852184003434

No Description
Synapse Biomedical, Inc.
22-0030
In Commercial Distribution

  • 00852184003434 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

Clinician Connector Kit - 00852184003427

No Description
Synapse Biomedical, Inc.
22-0029
In Commercial Distribution

  • 00852184003427 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

ClearView - 00815198012410

Smoke Evacuation Unit
Buffalo Filter
220V
Not in Commercial Distribution

  • 00815198012410 ()
60-8585-230

  • Surgical plume evacuation system

ClearView - 00815198012403

Smoke Evacuation Unit
Buffalo Filter
120V
Not in Commercial Distribution

  • 00815198012403 ()
60-8585-120

  • Surgical plume evacuation system

Charcoal Output Filter - 00817688021704

No Description
I.C. MEDICAL, INC.
2220
Not in Commercial Distribution

  • 00817688021704 ()
ICM-000-0421

  • Surgical plume evacuation system
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