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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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FloProbe 3/8" x 3/8” (Sterile) - 00814321020186

The brand name for this component is IBC FloProbe and is part of the AcuFlo system of products. This component is used in conjunction with the Medtronic Biomedicus Flow Pump System during open heart procedures. The IBC FloProbe is a direct product substitution for the Medtronic/Biomedicus Bioprobe, DP38.
Movair, Inc.
3080S
Not in Commercial Distribution

  • 00814321020186 ()


  • Electromagnetic blood flowmeter

FloProbe 1/4’’ x 1/4’’ (Sterile) - 00814321020162

The brand name for this component is IBC FloProbe and is part of the AcuFlo system of products. This component is used in conjunction with the Medtronic Biomedicus Flow Pump System during open heart procedures. The IBC FloProbe is a direct product substitution for the Medtronic/Biomedicus Bioprobe, DP38P.
Movair, Inc.
3090S
Not in Commercial Distribution

  • 00814321020162 ()


  • Electromagnetic blood flowmeter

CitriSol - B467CSP4522575100

CitriSol Dry Concentrate for Bicarbonate Dialysis
DIASOL, INC.
CSP45225-75100
In Commercial Distribution

  • B467CSP4522575100 ()
  • B467CSP452257510016 ()
CSP3

  • Haemodialysis concentrate

NA - 00724995182304

The 2-inch - IA Board Pad is used with surgical tables.
STERIS CORPORATION
Table Pad
In Commercial Distribution

  • 00724995182304 ()
BF828

  • Operating table mattress, basic

NA - 00724995178260

Catheter extension is used with the CMAX X-Ray Imaging Table
STERIS
TAB800KT
Not in Commercial Distribution

  • 00724995178260 ()
BF789

  • Surgical instrument interim-placement holder, reusable

NA - 00724995194017

The Femur Hook, Angled 58-degree is used with orthopedic procedures.
STERIS CORPORATION
Femur Hook
In Commercial Distribution

  • 00724995194017 ()
BF677

  • Bone hook

NA - 00724995171476

The 2-inch Cone-Shaped Headrest Pad is used with cone-shaped headrest.
STERIS CORPORATION
Table Pad
In Commercial Distribution

  • 00724995171476 ()
BF83

  • Multifunction body cushion

NA - 00724995171414

The IM Nailing-Hip Rest Pad is used with surgical tables.
STERIS CORPORATION
Table Pad
In Commercial Distribution

  • 00724995171414 ()
BF827

  • Operating table mattress, basic

NA - 00724995167912

The 2-inch, IA Extender Pad is used with surgical tables.
STERIS CORPORATION
Table Pad
In Commercial Distribution

  • 00724995167912 ()
BF829

  • Multifunction body cushion

NA - 00724995167899

The 9-inch Urology Extension Pad is used with surgical tables.
STERIS CORPORATION
Table Pad
In Commercial Distribution

  • 00724995167899 ()
BF83400053

  • Multifunction body cushion

NA - 00724995167875

The TLT 4-inch Armboard Pad is used with surgical tables.
STERIS CORPORATION
Table Pad
In Commercial Distribution

  • 00724995167875 ()
BF394

  • Operating table mattress, basic

NA - 00724995167868

The 2-inch, Multi-Posture Armboard Pad is used with surgical tables.
STERIS CORPORATION
Table Pad
In Commercial Distribution

  • 00724995167868 ()
BF81

  • Operating table mattress, basic

NA - 00724995167851

The 2-inch, Foot Extension Pad is used with surgical table.
STERIS CORPORATION
Table Pad
In Commercial Distribution

  • 00724995167851 ()
BF816

  • Multifunction body cushion

NA - 00724995167844

The 3-inch TLT Armboard Pad is used with surgical tables.
STERIS CORPORATION
Table Pad
In Commercial Distribution

  • 00724995167844 ()
BF327

  • Operating table mattress, basic

NA - 00724995164652

The Gross Traction Slide Package is used with traction devices.
STERIS CORPORATION
BF782
In Commercial Distribution

  • 00724995164652 ()
BF782

  • Orthopaedic operating table, electrohydraulic

NA - 00724995164553

The Orthopedic Extension is used with the Orthopedic Surgical Table.
STERIS CORPORATION
BF806
In Commercial Distribution

  • 00724995164553 ()
BF806

  • Orthopaedic operating table, electrohydraulic

NA - 00724995164515

The Cardiovascular Accessory Package is used with STERIS Surgical Tables.
STERIS CORPORATION
BF412
Not in Commercial Distribution

  • 00724995164515 ()
BF412

  • Universal operating table top

NA - 00724995163983

The HLT Foot Section is used with 3085 Surgical Table.
STERIS CORPORATION
Table Pad
In Commercial Distribution

  • 00724995163983 ()
BF393

  • Multifunction body cushion

NA - 00724995158224

The Gross Traction Slide Device is used with traction devices.
STERIS CORPORATION
BF877
In Commercial Distribution

  • 00724995158224 ()
BF877

  • Orthopaedic operating table, electrohydraulic

NA - 00724995171735

The CF Extension 2.25-inch Pad is used with surgical tables.
STERIS CORPORATION
Table Pad
In Commercial Distribution

  • 00724995171735 ()
BF495

  • Multifunction body cushion

NA - 00724995171711

The 4-inch Armboard Cone-Shaped Pad is used with surgical tables.
STERIS CORPORATION
Table Pad
In Commercial Distribution

  • 00724995171711 ()
BF407

  • Operating table mattress, basic

NA - 00724995171704

The 4-inch Armboard, Multi-Axis Pad is used with surgical tables.
STERIS CORPORATION
Table Pad
In Commercial Distribution

  • 00724995171704 ()
BF404

  • Operating table mattress, basic

NA - 00724995171650

The 4-inch Multi-Task Armboard Pad is used with surgical tables.
STERIS CORPORATION
Table Pad
In Commercial Distribution

  • 00724995171650 ()
BF375

  • Operating table mattress, basic

NA - 00724995171544

The Arthroscopy Holder Pad Set is used with surgical tables.
STERIS CORPORATION
Table Pad
In Commercial Distribution

  • 00724995171544 ()
BF718

  • Operating table mattress, basic

STAT Medical Devices - 00709334883883

The Disposable Safety Lancet is intended for capillary blood sampling.
Stat Medical Devices, Inc.
Qwik-Lance Safety Lancet
In Commercial Distribution

  • 30709334883884 ()
  • 00709334883883 ()
RQL-100

  • Manual blood lancing device, single-use

STAT Medical Devices - 00709334761884

The Disposable Safety Lancet is intended for capillary blood sampling.
Stat Medical Devices, Inc.
Qwik-Lance Safety Lancet
In Commercial Distribution

  • 40709334761882 ()
  • 00709334761884 ()
RQN-100

  • Manual blood lancing device, single-use

oneNEST S - 00670482000708

oneNEST S 80''x 35'' is a non-powered foam surface
Umano Medical Inc
303-803508HS4FB-BIL
In Commercial Distribution

  • 00670482000708 ()
  • 10670482000705 ()
303-803508HS4FB-BIL

  • Foam bed mattress

oneNEST S - 00670482000692

oneNEST S 84" x 35'' is a non-powered foam surface
Umano Medical Inc
303-843508HS4FB-BIL
In Commercial Distribution

  • 00670482000692 ()
  • 10670482000699 ()
303-843508HS4FB-BIL

  • Foam bed mattress

IV Pole - 00670482000586

It's a stand which is equipped of 2 hanging hooks.
Umano Medical Inc
FA64523-TRI
In Commercial Distribution

  • 10670482000583 ()
  • 00670482000586 ()
FA64523-TRI

  • Freestanding/bed-attached intravenous pole

IV Pole - 00670482000579

It's a stand which is equipped of 2 hanging hooks.
Umano Medical Inc
FA64521-TRI
In Commercial Distribution

  • 10670482000576 ()
  • 00670482000579 ()
FA64521-TRI

  • Freestanding/bed-attached intravenous pole

IV Pole - 00670482000562

It's a stand which is equipped of 2 hanging hooks.
Umano Medical Inc
FA64507-TRI
In Commercial Distribution

  • 10670482000569 ()
  • 00670482000562 ()
FA64507-TRI

  • Freestanding/bed-attached intravenous pole

IV Pole - 00670482000548

It's a stand which is equipped of 2 hanging hooks.
Umano Medical Inc
FA64508-TRI
In Commercial Distribution

  • 10670482000545 ()
  • 00670482000548 ()
FA64508-TRI

  • Freestanding/bed-attached intravenous pole

IV Pole - 00670482000531

It's a stand which is equipped of 2 hanging hooks.
Umano Medical Inc
FA64506-TRI
In Commercial Distribution

  • 10670482000538 ()
  • 00670482000531 ()
FA64506-TRI

  • Freestanding/bed-attached intravenous pole

LiNA OperaScopeTM Lasso - 05708265011889

LiNA OperaScopeTM Lasso is intended for use in hysteroscopy procedures.
Lina Medical ApS
OP-LAS16-3
In Commercial Distribution

  • 05708265011896 ()
  • 05708265011889 ()
OP-LAS16-3

  • Mechanical-cutting endoscopic polypectomy snare

LiNA OperaScopeTM Lasso - 05708265011537

LiNA OperaScopeTM Lasso is intended for use in hysteroscopy procedures.
Lina Medical ApS
OP-LAS16-3
Not in Commercial Distribution

  • 05708265011537 ()
  • 05708265011544 ()
OP-LAS16-3

  • Mechanical-cutting endoscopic polypectomy snare

identifeye Camera System, reconditioned - 00850067214281

The identifeye Camera System is a fundus ophthalmic camera reconditioned.
Identifeye Health Inc.
850-30004-00
In Commercial Distribution

  • 00850067214281 ()


  • Ophthalmic fundus camera

Magic Mix Pre-Polish Paste - D9497001111

Paste used to polish teeth after dental restoration is complete
Bioclear Matrix Systems
Mint
In Commercial Distribution

  • D9497001111 ()


  • Dentifrice

PARAMED - 00856324008730

Is a digital device used to measure blood pressure (Upper-arm)
SILEX GLOBAL LLC
Digital Blood Pressure Monitor (Upper-arm) B22S
In Commercial Distribution

  • 00856324008730 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

PARAMED - 00856324008723

Is a digital device used to measure blood pressure (Upper-arm)
SILEX GLOBAL LLC
Digital Blood Pressure Monitor (Upper-arm) B15
In Commercial Distribution

  • 00856324008723 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

PARAMED - 00856324008693

Is a digital device used to measure blood pressure (Upper-arm)
SILEX GLOBAL LLC
Digital Blood Pressure Monitor (Upper-arm) B22
In Commercial Distribution

  • 00856324008693 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
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