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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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ClearLLab 10C - 15099590701475

ClearLLab 10C B Cell Tube
BECKMAN COULTER IRELAND INC.
B96805
In Commercial Distribution

  • 15099590701475 ()


  • Multiple CD cell marker IVD, antibody

CARDINAL HEALTH - 10197106384732

OPEN HEART PACK A B
Cardinal Health 200, LLC
SCVOCOHV20
In Commercial Distribution

  • 50197106384730 ()
  • 10197106384732 ()
SCVOCOHV20

  • Cardiothoracic surgical procedure kit, non-medicated, single-use

Trumpf Medical - 00887761980006

Pad universal section H B
Baxter Medical Systems GmbH + Co. KG
2072448
Not in Commercial Distribution

  • 00887761980006 ()


  • Operating table patient pressure distribution pad, reusable

Pads PST500 - 00887761973541

Pad universal section H B
Baxter Medical Systems GmbH + Co. KG
2072448
Not in Commercial Distribution

  • 00887761973541 ()


  • Operating table patient pressure distribution pad, reusable

Pads PST500 - 00887761973527

Pad seat section H B
Baxter Medical Systems GmbH + Co. KG
2072452
Not in Commercial Distribution

  • 00887761973527 ()


  • Operating table patient pressure distribution pad, reusable

Pads PST500 - 00887761973510

Pad back section H B
Baxter Medical Systems GmbH + Co. KG
2072453
Not in Commercial Distribution

  • 00887761973510 ()


  • Operating table patient pressure distribution pad, reusable

Pads - 00887761969452

Pad TTS Carbon 450 B
Baxter Medical Systems GmbH + Co. KG
1873463
Not in Commercial Distribution

  • 00887761969452 ()


  • Operating table mattress, basic

Pads - 00887761969810

Pad head section H B
Baxter Medical Systems GmbH + Co. KG
1764878
Not in Commercial Distribution

  • 00887761969810 ()


  • Operating table mattress, basic

Pads - 00887761969643

Pad Carbon X-TRA 7500 B
Baxter Medical Systems GmbH + Co. KG
1851928
Not in Commercial Distribution

  • 00887761969643 ()


  • Operating table mattress, basic

Pads - 00887761969582

Pad upper back section B
Baxter Medical Systems GmbH + Co. KG
1851978
Not in Commercial Distribution

  • 00887761969582 ()


  • Operating table patient pressure distribution pad, reusable

Pads - 00887761969575

Pad head section 530 B
Baxter Medical Systems GmbH + Co. KG
1851979
Not in Commercial Distribution

  • 00887761969575 ()


  • Operating table patient pressure distribution pad, reusable

Pads - 00887761969537

Pad pelvis extension long B
Baxter Medical Systems GmbH + Co. KG
1851983
Not in Commercial Distribution

  • 00887761969537 ()


  • Operating table patient pressure distribution pad, reusable

Pads - 00887761969506

Pad leg section X-RAY B
Baxter Medical Systems GmbH + Co. KG
1851986
Not in Commercial Distribution

  • 00887761969506 ()


  • Operating table patient pressure distribution pad, reusable

Pads - 00887761969490

Pad shoulder basis segment B
Baxter Medical Systems GmbH + Co. KG
1851987
Not in Commercial Distribution

  • 00887761969490 ()


  • Operating table patient pressure distribution pad, reusable

Pads - 00887761969445

Pad TTS Carbon 600 B
Baxter Medical Systems GmbH + Co. KG
1873464
Not in Commercial Distribution

  • 00887761969445 ()


  • Operating table mattress, basic

Pads - 00887761969438

Pad TTS Carbon narrow B
Baxter Medical Systems GmbH + Co. KG
1873465
Not in Commercial Distribution

  • 00887761969438 ()


  • Operating table mattress, basic

Pads - 00887761969407

Pad Transfer Leg section B
Baxter Medical Systems GmbH + Co. KG
1880219
Not in Commercial Distribution

  • 00887761969407 ()


  • Operating table patient pressure distribution pad, reusable

Pads - 00887761969360

Pad pelvic extension H B
Baxter Medical Systems GmbH + Co. KG
1909818
Not in Commercial Distribution

  • 00887761969360 ()


  • Operating table patient pressure distribution pad, reusable

Orthopedic Extension - 00887761967687

Supporting pad hip TS3000 B
Baxter Medical Systems GmbH + Co. KG
2069352
Not in Commercial Distribution

  • 00887761967687 ()


  • Operating table orthopaedic extension, non-powered

Orthopedic Extension - 00887761967670

Supporting pad universal TS3000 B
Baxter Medical Systems GmbH + Co. KG
2069354
Not in Commercial Distribution

  • 00887761967670 ()


  • Operating table orthopaedic extension, non-powered

RLV-2100"B" Vacuum Relief Valve - 20634624413225

RLV-2100"B" Vacuum Relief Valve_nonsterile
QUEST MEDICAL INC
4103202
In Commercial Distribution

  • 20634624413225 ()
  • 00634624413221 ()
4103202

  • Cardiopulmonary bypass system valve, unidirectional flow/pressure control

CARDINAL HEALTH - 10197106138106

KIT,OPEN HEART A B
Cardinal Health 200, LLC
PVDHOH677
In Commercial Distribution

  • 50197106138104 ()
  • 10197106138106 ()
PVDHOH677

  • Cardiothoracic surgical procedure kit, medicated, single-use

CARDINAL HEALTH - 10197106135709

HEART PACK A AND B
Cardinal Health 200, LLC
SCV55OP611
In Commercial Distribution

  • 50197106135707 ()
  • 10197106135709 ()
SCV55OP611

  • Cardiothoracic surgical procedure kit, medicated, single-use

CARDINAL HEALTH - 10197106126493

OPEN HEART PACK A B
Cardinal Health 200, LLC
SCVOCOHV16
In Commercial Distribution

  • 50197106126491 ()
  • 10197106126493 ()
SCVOCOHV16

  • Cardiothoracic surgical procedure kit, non-medicated, single-use

RAP-PAC - 00885556541289

1.2 RAP-PAC B LATEX FREE
Smith & Nephew, Inc.
72202797
In Commercial Distribution

  • 00885556541289 ()
72202797

  • Arthroscopic surgical procedure kit, non-medicated, single-use

DeRoyal - 00749756596343

TOTAL HIP TRAY A & B
DEROYAL INDUSTRIES, INC.
89-4562
In Commercial Distribution

  • 00749756596343 ()


  • General surgical procedure kit, non-medicated, single-use

DeRoyal - 00749756653572

CABG PACK PGYBK A & B
DEROYAL INDUSTRIES, INC.
89-5985
In Commercial Distribution

  • 00749756653572 ()


  • General surgical procedure kit, non-medicated, single-use

CERABIEN™ ZR - EKUR1045791KA0

FC PASTE STAIN B+ 3g
KURARAY NORITAKE DENTAL INC.
104-5791KA
In Commercial Distribution

  • EKUR1045791KA0 ()


  • Dental appliance fabrication material, ceramic

MEDLINE INDUSTRIES, INC. - 10198459420696

BAG B ADULT INTUBATION KIT
MEDLINE INDUSTRIES, INC.
ACC011022
In Commercial Distribution

  • 40198459420697 ()
  • 10198459420696 ()
ACC011022

  • General surgical procedure kit, non-medicated, single-use

MEDLINE INDUSTRIES, INC. - 10198459429569

OPEN HEART PACK PART B
MEDLINE INDUSTRIES, INC.
DYNJ88678A
In Commercial Distribution

  • 40198459429560 ()
  • 10198459429569 ()
DYNJ88678A

  • General surgical procedure kit, non-medicated, single-use

A.L.P.S. mvX™ - 00196449033386

ANKLE SCREW RACK LID B
Tyber Medical, LLC
770107060
In Commercial Distribution

  • 00196449033386 ()


  • Surgical instrument/implant rack

CARDINAL HEALTH - 10198956173712

KIT, BAG B ADULT INTUBATION
Cardinal Health 200, LLC
ANE6973376
In Commercial Distribution

  • 50198956173710 ()
  • 10198956173712 ()
ANE6973376

  • General surgical procedure kit, non-medicated, single-use

NA - 00763000140175

SLEEVE 5580151 TYPE B 4.75
MEDTRONIC SOFAMOR DANEK, INC.
5580151
In Commercial Distribution

  • 00763000140175 ()


  • Orthopaedic surgical distractor, internal

CARDINAL HEALTH - 10197106077085

OPEN HEART PACK A B
Cardinal Health 200, LLC
SCVOCOHV15
In Commercial Distribution

  • 50197106077083 ()
  • 10197106077085 ()
SCVOCOHV15

  • Cardiothoracic surgical procedure kit, non-medicated, single-use

CARDINAL HEALTH - 10197106077030

CV A AND B PACK
Cardinal Health 200, LLC
SCV37CVJOJ
In Commercial Distribution

  • 50197106077038 ()
  • 10197106077030 ()
SCV37CVJOJ

  • Cardiothoracic surgical procedure kit, medicated, single-use

CARDINAL HEALTH - 10197106076743

CV A AND B PACK
Cardinal Health 200, LLC
SCV37CVJ20
In Commercial Distribution

  • 50197106076741 ()
  • 10197106076743 ()
SCV37CVJ20

  • Cardiothoracic surgical procedure kit, medicated, single-use

CARDINAL HEALTH - 10197106072431

B V IMPLANTE DE ORTOPEDIA
Cardinal Health 200, LLC
SOP30IDPR4
In Commercial Distribution

  • 50197106072439 ()
  • 10197106072431 ()
SOP30IDPR4

  • Orthopaedic surgical procedure kit, medicated

BENCO - 00366975018922

CROWN REMOVER MORRELL TIP B
BENCO DENTAL SUPPLY CO.
2010-977
In Commercial Distribution

  • 00366975018922 ()

  • Length: 3.5 Inch


  • Tooth extraction forceps

Trinity Biotech - 05391516747547

B. burgdorferi Wash Buffer (10x)
CLARK LABORATORIES, INC.
40-1013
In Commercial Distribution

  • 05391516747547 ()

  • Total Volume: 100 Milliliter
40-1013

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)

DeRoyal - 00749756965248

EMERGENT BYPASS PACK A & B
DEROYAL INDUSTRIES, INC.
89-9932
In Commercial Distribution

  • 50749756965243 ()
  • 00749756965248 ()


  • General surgical procedure kit, non-medicated, single-use
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