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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Perform Stem Tissue Tensioner
TORNIER, INC.
9027256
In Commercial Distribution

  • 00846832095766 ()

  • Size: 39
9027256

  • Hand-held surgical retractor, reusable
Perform Stem Tissue Tensioner
TORNIER, INC.
9027255
In Commercial Distribution

  • 00846832095759 ()

  • Size: 36
9027255

  • Hand-held surgical retractor, reusable
Perform Stem Tissue Tensioner
TORNIER, INC.
9027254
In Commercial Distribution

  • 00846832095742 ()

  • Size: 33
9027254

  • Hand-held surgical retractor, reusable
Posterior Retractor W/ Spike
TORNIER, INC.
9027229
In Commercial Distribution

  • 00846832095612 ()
9027229

  • Hand-held surgical retractor, reusable
SSA Retractor
TORNIER, INC.
9027218
In Commercial Distribution

  • 00846832095605 ()

  • Size: Large
9027218

  • Hand-held surgical retractor, reusable
SSA Retractor
TORNIER, INC.
9027217
In Commercial Distribution

  • 00846832095599 ()

  • Size: Small
9027217

  • Hand-held surgical retractor, reusable
Backup Battery Module
Asia Pacific Medical Technology Development Company Limited
SG1000-BBM-001
In Commercial Distribution

  • 04897102200065 ()
SG1000-BBM-001

  • Cardiopulmonary bypass system centrifugal pump drive unit
Micro Hook Curved, 1.8mm, 18.5cm Stainless
MIZUHO CORPORATION
07-867-02
In Commercial Distribution

  • 04946329059052 ()

  • Length: 185 Millimeter
07-867-02

  • Soft-tissue surgical hook, reusable
Micro Hook Straight, 1.8mm, 18.5cm Stainless
MIZUHO CORPORATION
07-867-01
In Commercial Distribution

  • 04946329059045 ()

  • Length: 185 Millimeter
07-867-01

  • Soft-tissue surgical hook, reusable
No Description
KONO SEISAKUSHO CO.,LTD.
0KEQ12WTGF
In Commercial Distribution

  • 04946585234620 ()
  • 14946585234627 ()
0KEQ12WTGF

  • Soft-tissue surgical hook, single-use
No Description
KONO SEISAKUSHO CO.,LTD.
NOGETUS1
In Commercial Distribution

  • 04946585157165 ()
  • 14946585157162 ()
NOGETUS1

  • Soft-tissue surgical hook, single-use
MOS-1302B (ASIA)
MIZUHO CORPORATION
18-470-21
In Commercial Distribution

  • 04946329310146 ()

  • Length: 2055 Millimeter
18-470-21

  • Universal operating table, electrohydraulic
BABY HOHMANN
TORNIER, INC.
MXS-067
In Commercial Distribution

  • 00846832047574 ()
MXS-067

  • Hand-held surgical retractor, reusable
Posterior Glenoid Retractor
TORNIER, INC.
MWH623
In Commercial Distribution

  • 00846832072705 ()
MWH623

  • Hand-held surgical retractor, reusable
-koplight Cordless Lighted Retractor is a medical device consisting of two main parts; koplight S blade/koplight HT S blade and koplight light handle. -koplight S blade/koplight HT S blade is a surgical retractor, and it retracts incisions and/or wounds to provide access to the operative field. koplight S blade/koplight HT S blade is sterilized single-use. -koplight light handle is an auxiliary surgical light, and it illuminates the operative field with LED light. -KG-2-SET koplight light handle set is packed with KG-2 koplight light handle (Infrared cut-off model), KY-1 koplight light handle finger hook, KP-1 koplight light handle O-ring and KD-1 koplight battery inserter.
YASUI CO.,LTD.
KG-2-SET
In Commercial Distribution

  • 04562231093597 ()

  • Outer Diameter: 15.0 Millimeter
  • Length: 155.0 Millimeter


  • Hand-held surgical retractor, single-use
-koplight Cordless Lighted Retractor is a medical device consisting of two main parts; koplight S blade/koplight HT S blade and koplight light handle. -koplight S blade/koplight HT S blade is a surgical retractor, and it retracts incisions and/or wounds to provide access to the operative field. koplight S blade/koplight HT S blade is sterilized single-use. -koplight light handle is an auxiliary surgical light, and it illuminates the operative field with LED light. -KG-1-SET koplight light handle set is packed with KG-1 koplight light handle, KY-1 koplight light handle finger hook, KP-1 koplight light handle O-ring and KD-1 koplight battery inserter.
YASUI CO.,LTD.
KG-1-SET
In Commercial Distribution

  • 04562231093580 ()

  • Outer Diameter: 15.0 Millimeter
  • Length: 155.0 Millimeter


  • Hand-held surgical retractor, single-use
-koplight Cordless Lighted Retractor is a medical device consisting of two main parts; koplight S blade/koplight HT S blade and koplight light handle. -koplight S blade/koplight HT S blade is a surgical retractor, and it retracts incisions and/or wounds to provide access to the operative field. koplight S blade/koplight HT S blade is sterilized single-use. -koplight light handle is an auxiliary surgical light, and it illuminates the operative field with LED light.
YASUI CO.,LTD.
KS-6HS
In Commercial Distribution

  • 34562231093529 ()
  • 04562231093528 ()

  • Width: 25.0 Millimeter
  • Length: 122.0 Millimeter


  • Hand-held surgical retractor, single-use
-koplight Cordless Lighted Retractor is a medical device consisting of two main parts; koplight S blade/koplight HT S blade and koplight light handle. -koplight S blade/koplight HT S blade is a surgical retractor, and it retracts incisions and/or wounds to provide access to the operative field. koplight S blade/koplight HT S blade is sterilized single-use. -koplight light handle is an auxiliary surgical light, and it illuminates the operative field with LED light.
YASUI CO.,LTD.
KS-5HS
In Commercial Distribution

  • 34562231093512 ()
  • 04562231093511 ()

  • Depth: 86.0 Millimeter
  • Width: 25.0 Millimeter
  • Length: 122.0 Millimeter


  • Hand-held surgical retractor, single-use
-koplight Cordless Lighted Retractor is a medical device consisting of two main parts; koplight S blade/koplight HT S blade and koplight light handle. -koplight S blade/koplight HT S blade is a surgical retractor, and it retracts incisions and/or wounds to provide access to the operative field. koplight S blade/koplight HT S blade is sterilized single-use. -koplight light handle is an auxiliary surgical light, and it illuminates the operative field with LED light.
YASUI CO.,LTD.
KS-4HS
In Commercial Distribution

  • 34562231093505 ()
  • 04562231093504 ()

  • Depth: 61.0 Millimeter
  • Width: 18.0 Millimeter
  • Length: 122.0 Millimeter


  • Hand-held surgical retractor, single-use
-koplight Cordless Lighted Retractor is a medical device consisting of two main parts; koplight S blade/koplight HT S blade and koplight light handle. -koplight S blade/koplight HT S blade is a surgical retractor, and it retracts incisions and/or wounds to provide access to the operative field. koplight S blade/koplight HT S blade is sterilized single-use. -koplight light handle is an auxiliary surgical light, and it illuminates the operative field with LED light.
YASUI CO.,LTD.
KS-4S
In Commercial Distribution

  • 34562231093482 ()
  • 04562231093481 ()

  • Depth: 59.0 Millimeter
  • Width: 18.0 Millimeter
  • Length: 113.0 Millimeter


  • Hand-held surgical retractor, single-use
-koplight Cordless Lighted Retractor is a medical device consisting of two main parts; koplight S blade/koplight HT S blade and koplight light handle. -koplight S blade/koplight HT S blade is a surgical retractor, and it retracts incisions and/or wounds to provide access to the operative field. koplight S blade/koplight HT S blade is sterilized single-use. -koplight light handle is an auxiliary surgical light, and it illuminates the operative field with LED light.
YASUI CO.,LTD.
KS-3S
In Commercial Distribution

  • 34562231093475 ()
  • 04562231093474 ()

  • Depth: 45.0 Millimeter
  • Width: 18.0 Millimeter
  • Length: 139.0 Millimeter


  • Hand-held surgical retractor, single-use
-koplight Cordless Lighted Retractor is a medical device consisting of two main parts; koplight S blade/koplight HT S blade and koplight light handle. -koplight S blade/koplight HT S blade is a surgical retractor, and it retracts incisions and/or wounds to provide access to the operative field. koplight S blade/koplight HT S blade is sterilized single-use. -koplight light handle is an auxiliary surgical light, and it illuminates the operative field with LED light.
YASUI CO.,LTD.
KS-2S
In Commercial Distribution

  • 34562231093468 ()
  • 04562231093467 ()

  • Depth: 45.0 Millimeter
  • Width: 13.0 Millimeter
  • Length: 139.0 Millimeter


  • Hand-held surgical retractor, single-use
-koplight Cordless Lighted Retractor is a medical device consisting of two main parts; koplight S blade/koplight HT S blade and koplight light handle. -koplight S blade/koplight HT S blade is a surgical retractor, and it retracts incisions and/or wounds to provide access to the operative field. koplight S blade/koplight HT S blade is sterilized single-use. -koplight light handle is an auxiliary surgical light, and it illuminates the operative field with LED light.
YASUI CO.,LTD.
KS-1S
In Commercial Distribution

  • 34562231093451 ()
  • 04562231093450 ()

  • Depth: 30.0 Millimeter
  • Width: 10.0 Millimeter
  • Length: 139.0 Millimeter


  • Hand-held surgical retractor, single-use
-koplight Cordless Lighted Retractor is a medical device consisting of two main parts; koplight S blade/koplight HT S blade and koplight light handle. -koplight S blade/koplight HT S blade is a surgical retractor, and it retracts incisions and/or wounds to provide access to the operative field. koplight S blade/koplight HT S blade is sterilized single-use. -koplight light handle is an auxiliary surgical light, and it illuminates the operative field with LED light.
YASUI CO.,LTD.
KG-2
In Commercial Distribution

  • 04562231093368 ()

  • Outer Diameter: 15.0 Millimeter
  • Length: 155.0 Millimeter


  • Hand-held surgical retractor, single-use
-koplight Cordless Lighted Retractor is a medical device consisting of two main parts; koplight S blade/koplight HT S blade and koplight light handle. -koplight S blade/koplight HT S blade is a surgical retractor, and it retracts incisions and/or wounds to provide access to the operative field. koplight S blade/koplight HT S blade is sterilized single-use. -koplight light handle is an auxiliary surgical light, and it illuminates the operative field with LED light.
YASUI CO.,LTD.
KA-1
In Commercial Distribution

  • 04562231093351 ()


  • Hand-held surgical retractor, single-use
-koplight Cordless Lighted Retractor is a medical device consisting of two main parts; koplight S blade/koplight HT S blade and koplight light handle. -koplight S blade/koplight HT S blade is a surgical retractor, and it retracts incisions and/or wounds to provide access to the operative field. koplight S blade/koplight HT S blade is sterilized single-use. -koplight light handle is an auxiliary surgical light, and it illuminates the operative field with LED light. -This product is a koplight light handle accessory.
YASUI CO.,LTD.
KD-1
In Commercial Distribution

  • 04562231093320 ()


  • Hand-held surgical retractor, single-use
-koplight Cordless Lighted Retractor is a medical device consisting of two main parts; koplight S blade/koplight HT S blade and koplight light handle. -koplight S blade/koplight HT S blade is a surgical retractor, and it retracts incisions and/or wounds to provide access to the operative field. koplight S blade/koplight HT S blade is sterilized single-use. -koplight light handle is an auxiliary surgical light, and it illuminates the operative field with LED light. -This product is a koplight light handle accessory.
YASUI CO.,LTD.
KY-1
In Commercial Distribution

  • 04562231093313 ()


  • Hand-held surgical retractor, single-use
-koplight Cordless Lighted Retractor is a medical device consisting of two main parts; koplight S blade/koplight HT S blade and koplight light handle. -koplight S blade/koplight HT S blade is a surgical retractor, and it retracts incisions and/or wounds to provide access to the operative field. koplight S blade/koplight HT S blade is sterilized single-use. -koplight light handle is an auxiliary surgical light, and it illuminates the operative field with LED light. -This product is a koplight light handle accessory.
YASUI CO.,LTD.
KP-1
In Commercial Distribution

  • 04562231093306 ()


  • Hand-held surgical retractor, single-use
-koplight Cordless Lighted Retractor is a medical device consisting of two main parts; koplight S blade/koplight HT S blade and koplight light handle. -koplight S blade/koplight HT S blade is a surgical retractor, and it retracts incisions and/or wounds to provide access to the operative field. koplight S blade/koplight HT S blade is sterilized single-use. -koplight light handle is an auxiliary surgical light, and it illuminates the operative field with LED light.
YASUI CO.,LTD.
KG-1
In Commercial Distribution

  • 04562231091074 ()

  • Outer Diameter: 15.0 Millimeter
  • Length: 155.0 Millimeter


  • Hand-held surgical retractor, single-use
LAP,MARYLAND,STD,ROT,W/O RATCH,5MM,3
MEDLINE INDUSTRIES, INC.
MDG76251126
In Commercial Distribution

  • 10080196287130 ()
MDG76251126

  • Hand-held surgical retractor, reusable
LAP,NH,IN-LINE,TC CVD LT,RATCH,5MM,3
MEDLINE INDUSTRIES, INC.
MDG7600251
In Commercial Distribution

  • 10080196286980 ()
MDG7600251

  • Hand-held surgical retractor, reusable
LAP,BABCOCK,PADDLE STYLE,10MM,37CM
MEDLINE INDUSTRIES, INC.
MDG44224377
In Commercial Distribution

  • 10080196284351 ()
MDG44224377

  • Hand-held surgical retractor, reusable
LAP,BABCOCK,INSL,RATCHET,5MM,45CM
MEDLINE INDUSTRIES, INC.
MDG44220368
In Commercial Distribution

  • 10080196284283 ()
MDG44220368

  • Hand-held surgical retractor, reusable
LAP,DISSECTOR,MARYLAND,FINE,5MM,35CM
MEDLINE INDUSTRIES, INC.
MDG466247
In Commercial Distribution

  • 10080196285044 ()
MDG466247

  • Hand-held surgical retractor, reusable
LAP,GRASP,BOWEL-HUNTER,ROTO,20MM DEB
MEDLINE INDUSTRIES, INC.
MDG244389
In Commercial Distribution

  • 10080196276462 ()
MDG244389

  • Hand-held surgical retractor, reusable
LAP,NH,IN-LINE,TC,STR,RATCH,5MM,35CM
MEDLINE INDUSTRIES, INC.
MDG2411251
In Commercial Distribution

  • 10080196275793 ()
MDG2411251

  • Hand-held surgical retractor, reusable
LAP,NH,IN-LINE,TC CVD RT,RATCH,5MM,3
MEDLINE INDUSTRIES, INC.
MDG2411051
In Commercial Distribution

  • 10080196275779 ()
MDG2411051

  • Hand-held surgical retractor, reusable
LAP,PROBE,PALPATION,BLNT,CALIBRATED,
MEDLINE INDUSTRIES, INC.
MDG2010045
In Commercial Distribution

  • 10080196273690 ()
MDG2010045

  • Hand-held surgical retractor, reusable
LAP,RETRACTOR,FAN,3FINGER,5MM,32CM
MEDLINE INDUSTRIES, INC.
MDG1815642
In Commercial Distribution

  • 10080196270958 ()
MDG1815642

  • Hand-held surgical retractor, reusable
SSK 16mL is a device used to transfer sample from bllod bags or other containers with sterile docking compatible tubing to vacuum containers for in-vitro tests. Single use only. The device is for use by trained laboratory staff, in a laboratory
ITL ASIA PACIFIC SDN. BHD.
A100756
In Commercial Distribution

  • 19555240405613 ()
  • 09555240405616 ()
A100756

  • Blood/blood culture specimen transfer spike IVD, manual
SCU Narrow Cap Sampler Syringe Kit is a needleless device used to transfer samples from blood culture bottles for blood culture testing. For single use only. The device is for use by trained laboratory staff, in a laboratory.
ITL ASIA PACIFIC SDN. BHD.
A100727
In Commercial Distribution

  • 19555240405590 ()
  • 09555240405593 ()
  • 29555240405597 ()
A100727

  • Blood/blood culture specimen transfer spike IVD, manual
IV Start Kit is a single-use, disposable procedure packs with various combination of components, such as adhesive dressing, underpad, gauze, label, tourniquet, and sterile field. The procedure packs are widely used by clinical professionals using aseptic technique for patient requires Intravenous Cannula Insertion.
ITL ASIA PACIFIC SDN. BHD.
IVSK100
In Commercial Distribution

  • 19555240405217 ()
  • 09555240405210 ()
  • 29555240405214 ()
IVSK100

  • Peripheral intravenous catheterization support kit
SCU Narrow Cap Sampler is a needleless device used to transfer samples from blood culture bottles for blood culture testing. For single use only. The device is for use by trained laboratory staff, in a laboratory.
ITL ASIA PACIFIC SDN. BHD.
A100724
In Commercial Distribution

  • 19555240404999 ()
  • 09555240404992 ()
  • 29555240404996 ()
A100724

  • Blood/blood culture specimen transfer spike IVD, manual
SCU Wide Cap Sampler is a needleless device used to transfer samples from blood culture bottles for blood culture testing. For single use only. The device is for use by trained laboratory staff, in a laboratory.
ITL ASIA PACIFIC SDN. BHD.
A100723
In Commercial Distribution

  • 09555240404985 ()
  • 19555240404982 ()
  • 29555240404989 ()
A100723

  • Blood/blood culture specimen transfer spike IVD, manual
SampLok® Sampling Kit (SSK) - 20mL is used to transfers samples from blood bags or other containers with sterile docking compatible tubing to vacuum containers for laboratory tests.
ITL ASIA PACIFIC SDN. BHD.
A100754
In Commercial Distribution

  • 19555240404081 ()
  • 09555240404084 ()
A100754

  • Blood/blood culture specimen transfer spike IVD, manual
SampLok® Sampling Kit (SSK): SSK-Mk3-35mL is used to transfer samples from blood bags or other containers with sterile docking compatible tubing to vacuum containers for laboratory tests.
ITL ASIA PACIFIC SDN. BHD.
A100752
Not in Commercial Distribution

  • 19555240403862 ()
  • 09555240403865 ()
A100752

  • Blood/blood culture specimen transfer spike IVD, manual
ITL Essentials™ Sharps Passing Tray Large is the sterile version of Sharps Passing Tray Large which is used for safe transfer of sharp surgical instruments during surgery. For single use only.
ITL ASIA PACIFIC SDN. BHD.
A500117
In Commercial Distribution

  • 19555240401608 ()
  • 09555240401601 ()
A500117

  • Surgical instrument interim-placement holder, single-use
SampLok® Adaptor Cap 3 (SAC 3) Insert is an optional accessory to be used with SAC 3 to facilitate collection of blood sample into vacuum tube(s). It is a single use device.
ITL ASIA PACIFIC SDN. BHD.
A100763
Not in Commercial Distribution

  • 19555240401554 ()
  • 09555240401557 ()
  • 29555240401551 ()
A100763

  • Blood collection tube holder, single-use
The SampLok® Adapter Cap has a Luer thread which facilitates attachment with commonly available multi-sample Luer adaptor; It is intended to facilitate collection of blood sample into either culture bottles or vacuum tubes. It is a single use device.
ITL ASIA PACIFIC SDN. BHD.
A100762
Not in Commercial Distribution

  • 19555240401547 ()
  • 09555240401540 ()
  • 29555240401544 ()
A100762

  • Blood collection tube holder, single-use
SampLok® Adaptor Cap 3 (SAC 3) Insert is an optional accessory to be used with SAC 3 to facilitate collection of blood sample into vacuum tube(s). It is a single use device.
ITL ASIA PACIFIC SDN. BHD.
A100761
In Commercial Distribution

  • 19555240401530 ()
  • 09555240401533 ()
  • 29555240401537 ()
A100761

  • Blood collection tube holder, single-use
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