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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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Auragen™ - 10381780035312

The AURAGEN™ Cortical Surface Electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci. They are placed on the exposed cortical surface or inserted into the subdural space to contact the cortical surface. Cortical Electrodes are available with platinum contacts and vary in size according to the number of contacts. The type of cortical electrode used is dependent on the procedure and the size of area being tested.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
40M85
Not in Commercial Distribution

  • M27240M851 ()
  • 10381780035312 ()

  • 24 platinum contacts


  • Cortical electrode

Auragen™ - 10381780035305

The AURAGEN™ Cortical Surface Electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci. They are placed on the exposed cortical surface or inserted into the subdural space to contact the cortical surface. Cortical Electrodes are available with platinum contacts and vary in size according to the number of contacts. The type of cortical electrode used is dependent on the procedure and the size of area being tested.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
40M84
Not in Commercial Distribution

  • M27240M841 ()
  • 10381780035305 ()

  • 24 platinum contacts


  • Cortical electrode

Auragen™ - 10381780036470

The AURAGEN™ Cortical Surface Electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci. They are placed on the exposed cortical surface or inserted into the subdural space to contact the cortical surface. Cortical Electrodes are available with platinum contacts and vary in size according to the number of contacts. The type of cortical electrode used is dependent on the procedure and the size of area being tested.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
AU6X2P2CD
Not in Commercial Distribution

  • M272AU6X2P2CD1 ()
  • 10381780036470 ()

  • 24 platinum contacts


  • Cortical electrode

Auragen™ - 10381780036388

The AURAGEN™ Cortical Surface Electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci. They are placed on the exposed cortical surface or inserted into the subdural space to contact the cortical surface. Cortical Electrodes are available with platinum contacts and vary in size according to the number of contacts. The type of cortical electrode used is dependent on the procedure and the size of area being tested.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
AU4X6P2
Not in Commercial Distribution

  • M272AU4X6P21 ()
  • 10381780036388 ()

  • 24 platinum contacts


  • Cortical electrode

Robinson Nelaton Catheter - 30768455145929

Robinson/Nelaton Catheter
CONVATEC, PURCHASING DEPARTMENT
503429
Not in Commercial Distribution

  • 30768455145929 ()
  • 50768455145923 ()
  • 70768455145927 ()

  • 24 FR 40cm
503429

  • Single-administration urethral drainage catheter

L2L® - 00889024582200

No Description
Zimmer, Inc.
00-8701-001-24
In Commercial Distribution

  • 00889024582200 ()

  • 24 mm Diameter
  • Height: 12.00 Millimeter
00-8701-001-24

  • Elbow radius prosthesis trial

L2L® - 00889024581968

No Description
Zimmer, Inc.
00-8700-001-24
In Commercial Distribution

  • 00889024581968 ()

  • Height: 12.00 Millimeter
  • 24 mm Diameter
00-8700-001-24

  • Elbow radius prosthesis

Symmetry Surgical - 00887482041338

Symmetry® Mirror, Laryngeal, Stationary Octagonal Handle, #6 24 mm
SYMMETRY SURGICAL INC.
73-4824
In Commercial Distribution

  • 00887482041338 ()

  • 24 mm Diameter
73-4824

  • Laryngeal mirror, reusable

Validate - 00850011135372

VALIDATE THY2 Calibration Verification / Linearity Test Kit solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range in automated instrument systems for the following analytes: Tg Set: Thyroglobulin (Tg) TU Set: T-Uptake (TU)
Lgc Clinical Diagnostics, Inc.
908bc
In Commercial Distribution

  • 00850011135372 ()


  • Thyroglobulin IVD, control
  • Multiple thyroid hormone uptake (T-uptake) IVD, control

KILT BLOCKER - 00840331272734

KILT BLOCKER SET - Standard Size with Hook and Loop Closure, .5mm Xenolite 800 NL Size S8T, 18"L X 20"W, 20"L X 24"W, 24"L X 24"W
BURLINGTON MEDICAL, LLC
R8KILTBLOCKERS8T
In Commercial Distribution

  • 00840331272734 ()


  • Radiation shielding apron

KILT BLOCKER - 00840331272857

KILT BLOCKER SET - Standard Size with Hook and Loop Closure, .25mm Xenolite 800 NL Size S8T, 18"L X 20"W, 20"L X 24"W, 24"L X 24"W
BURLINGTON MEDICAL, LLC
U8KILTBLOCKERS8T
In Commercial Distribution

  • 00840331272857 ()


  • Radiation shielding apron

KILT BLOCKER - 00840331272796

KILT BLOCKER SET - Standard Size with Hook and Loop Closure, .35mm Xenolite 800 NL Size S8T, 18"L X 20"W, 20"L X 24"W, 24"L X 24"W
BURLINGTON MEDICAL, LLC
S8KILTBLOCKERS8T
In Commercial Distribution

  • 00840331272796 ()


  • Radiation shielding apron

MedibinoNEO ring – TG PUR Gel - Size S - PU6 - 04260764840571

Positioning premature infants is a major challenge in intensive care. Newborn babies in general, but especially premature babies, are less active and often lie in one position. As a result, certain body parts are exposed to increased pressure. As the bones of the skull are still very soft in the first months of life, the head is sensitive to permanent pressure. This is particularly critical for premature babies, as the skull is still softer due to the low maturity at birth. Premature babies often have to be monitored in the hospital for several months and also have to stay in an incubator. Head deformations, such as plagiocephaly, brachycephaly and dolichocephaly, are often the result of unilateral positioning of premature and newborn babies on their sides or backs. In studies, the incidence of head deformations in premature babies is reported to be up to 90 %. With the Medibino Neo positioning system, we provide a solution for pressure-relieving positioning and stabilisation of the mid-head position of premature babies and infants during long hospital stays.
Kluba Medical GmbH
1
In Commercial Distribution

  • 04260764840724 ()
  • 04260764840571 ()

  • Fits for premature infants weighting 200-800g
24021703-S

  • Infant recumbent sleep positioner

MedibinoNEO ring – TG PUR Gel - Size M - PU6 - 04260764840564

Positioning premature infants is a major challenge in intensive care. Newborn babies in general, but especially premature babies, are less active and often lie in one position. As a result, certain body parts are exposed to increased pressure. As the bones of the skull are still very soft in the first months of life, the head is sensitive to permanent pressure. This is particularly critical for premature babies, as the skull is still softer due to the low maturity at birth. Premature babies often have to be monitored in the hospital for several months and also have to stay in an incubator. Head deformations, such as plagiocephaly, brachycephaly and dolichocephaly, are often the result of unilateral positioning of premature and newborn babies on their sides or backs. In studies, the incidence of head deformations in premature babies is reported to be up to 90 %. With the Medibino Neo positioning system, we provide a solution for pressure-relieving positioning and stabilisation of the mid-head position of premature babies and infants during long hospital stays.
Kluba Medical GmbH
1
In Commercial Distribution

  • 04260764840564 ()
  • 04260764840717 ()

  • Fits for premature infants weighting 800-2000g
24021703-M

  • Infant recumbent sleep positioner

IMMULITE® Systems TG Calibration Verification Material Thyroglobulin - 00630414979472

Thyroglobulin CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10388175
In Commercial Distribution

  • 00630414979472 ()
LTYCVM

  • Thyroglobulin antibody IVD, control

IMMULITE®/IMMULITE® 1000 Systems TG Thyroglobulin - 00630414972077

Thyreoglobulin - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381638
In Commercial Distribution

  • 00630414972077 ()
LKTY1(D)

  • Thyroglobulin antibody IVD, kit, chemiluminescent immunoassay

BT37 Incubator - B199GDBT37WWORIGIO0

BT37 Benchtop Incubator
PLANER LIMITED
GDBT37-WW-ORIGIO
In Commercial Distribution

  • B199GDBT37WWORIGIO0 ()


  • Assisted reproduction heater/incubator

BT37 Incubator - B199GDBT37USORIGIO0

BT37 Benchtop Incubator.
PLANER LIMITED
GDBT37-US-ORIGIO
In Commercial Distribution

  • B199GDBT37USORIGIO0 ()


  • Assisted reproduction heater/incubator

BT37 Incubator - B199GDBT3701ORIGIO0

BT37 Benchtop Incubator - Origio
PLANER LIMITED
GDBT37-01-ORIGIO
In Commercial Distribution

  • B199GDBT3701ORIGIO0 ()


  • Assisted reproduction heater/incubator

Powder Coated Grab Bar 24" - 00616784030814

No Description
Dynarex Corporation
10308
In Commercial Distribution

  • 00616784030814 ()


  • Parallel bar exerciser, non-powered

AxioModelling Wax 500g 24 sheets - D161280190

No Description
Axiodent Inc.
28019
In Commercial Distribution

  • D161280190 ()


  • Denture trial fabrication wax

32" x 24" Adaptive Desk - 00850001752473

Adaptive classroom desk
RIFTON EQUIPMENT
R240
In Commercial Distribution

  • 00850001752473 ()


  • Ergonomic workdesk, manual

Vent diffuser kit 24 pack - 00850003157092

No Description
BLEEP, LLC
100605
In Commercial Distribution

  • 10850003157099 ()
  • 00850003157092 ()


  • Home CPAP unit

BOJRAB DISSECTOR, LARGE, ANGLED 24° - 00844505013697

BOJRAB DISSECTOR, LARGE, ANGLED 24° 2.1MM X 1.8MM STAINLESS STEEL
Grace Medical, Inc.
999-DB1
In Commercial Distribution

  • 00844505013697 ()


  • Open-surgery dissector

TRI-PANEL KNEE IMMOB 24" BLK - 00610570103645

No Description
Bird & Cronin, LLC
08142747
In Commercial Distribution

  • 00610570103645 ()


  • Knee sling

24" COMFOR KNEE IMMOB UNIV - 00610570010509

No Description
Bird & Cronin, LLC
08142664
In Commercial Distribution

  • 00610570010509 ()


  • Knee sling

QUICK-WRAP IMMOB 24" UNIV CONT - 00610570010448

No Description
Bird & Cronin, LLC
08142658
In Commercial Distribution

  • 00610570010448 ()


  • Knee sling

QUICK-WRAP IMMOB 24" UNIV STRT - 00610570010400

No Description
Bird & Cronin, LLC
08142654
In Commercial Distribution

  • 00610570010400 ()


  • Knee sling

PAD, 3" 24" CONTOURED ARMBOARD - 00842430100673

Made with Tempur-Pedic® Medical materials.
MIZUHO ORTHOPEDIC SYSTEMS, INC.
69453
In Commercial Distribution

  • 00842430100673 ()
69453

  • Operating table mattress, basic

PAD, 2" 24" CONTOURED ARMBOARD - 00842430100666

Made with Tempur-Pedic® Medical materials.
MIZUHO ORTHOPEDIC SYSTEMS, INC.
69452
In Commercial Distribution

  • 00842430100666 ()
69452

  • Operating table mattress, basic

PAD, 4" 24" FLAT ARMBOARD - 00842430100659

Made with Tempur-Pedic® Medical materials.
MIZUHO ORTHOPEDIC SYSTEMS, INC.
69444
In Commercial Distribution

  • 00842430100659 ()
69444

  • Operating table mattress, basic

2" 24" FLAT ARMBOARD PAD - 00842430100604

Made with Tempur-Pedic® Medical materials.
MIZUHO ORTHOPEDIC SYSTEMS, INC.
69442
In Commercial Distribution

  • 00842430100604 ()
69442

  • Operating table mattress, basic

PKIT, COVER, PAD, 24/CS - 00842430104374

No Description
MIZUHO ORTHOPEDIC SYSTEMS, INC.
5844-17
In Commercial Distribution

  • 00842430104374 ()
  • 00842430111860 ()
5844-17

  • Medical equipment/instrument drape, single-use

SONICflex rootplaner Tip No. 24 - EKAV057156210

This is a medical device.
KaVo Dental GmbH
0.571.5621
In Commercial Distribution

  • EKAV057156210 ()
rootplaner Tip No 24

  • Ultrasonic dental scaling/debridement system

CONDUIT ATP 6mm Spreader 24° - 09421028118460

Intended to be used for the insertion of spinal implants into the spinal space during total artificial disc replacement surgery.
ENZTEC LIMITED
287363246
In Commercial Distribution

  • 09421028118460 ()
287363246

  • Orthopaedic inorganic implant inserter/extractor, reusable

CONDUIT ATP 4mm Spreader 24° - 09421028118446

Intended to be used for the insertion of spinal implants into the spinal space during total artificial disc replacement surgery.
ENZTEC LIMITED
287363244
In Commercial Distribution

  • 09421028118446 ()
287363244

  • Orthopaedic inorganic implant inserter/extractor, reusable

CONDUIT ATP Trial Inserter 24° - 09421028118385

Intended to be used for the insertion of spinal implants into the spinal space during total artificial disc replacement surgery.
ENZTEC LIMITED
LET20224T
In Commercial Distribution

  • 09421028118385 ()
LET20224T

  • Orthopaedic inorganic implant inserter/extractor, reusable

CONDUIT ATP Implant Inserter 24° - 09421028118361

Intended to be used for the insertion of spinal implants into the spinal space during total artificial disc replacement surgery.
ENZTEC LIMITED
LET30324T
In Commercial Distribution

  • 09421028118361 ()
LET30324T

  • Orthopaedic inorganic implant inserter/extractor, reusable

1-Level Cervical Plates, 24 mm - M739CP300240

No Description
CAPTIVA SPINE, INC.
CP30024
In Commercial Distribution

  • M739CP300240 ()


  • Spinal fixation plate, non-bioabsorbable

TRANSFER BOARD MAPLE 24 IN - 00733657224382

No Description
ALIMED, INC.
8502
In Commercial Distribution

  • 00733657224382 ()
2970011228

  • Patient transfer sliding board
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