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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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Positive Serum Control - 10888234500643

For Use with PakPlus
IMMUCOR GTI DIAGNOSTICS, INC.
404601
Not in Commercial Distribution

  • 10888234500643 ()
404601

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent

Positive Serum Control - 10888234500636

For Use with PakAuto
IMMUCOR GTI DIAGNOSTICS, INC.
404600
Not in Commercial Distribution

  • 10888234500636 ()
404600

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent

Positive Serum Control - 10888234500629

For Use with Pak2-LE
IMMUCOR GTI DIAGNOSTICS, INC.
404598
Not in Commercial Distribution

  • 10888234500629 ()
404598

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent

Positive Serum Control - 10888234500612

For Use with Pak12G
IMMUCOR GTI DIAGNOSTICS, INC.
404597
Not in Commercial Distribution

  • 10888234500612 ()
404597

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent

Positive Serum Control - 10888234500605

For Use with Pak12
IMMUCOR GTI DIAGNOSTICS, INC.
404596
Not in Commercial Distribution

  • 10888234500605 ()
404596

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent

Cell Resuspension and Preservative Solution - 10888234500599

For Use with PakAuto
IMMUCOR GTI DIAGNOSTICS, INC.
404590
Not in Commercial Distribution

  • 10888234500599 ()
404590

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent

Anti-Human IgG/A/M Conjugate - 10888234500575

For Use with PakAuto
IMMUCOR GTI DIAGNOSTICS, INC.
404588
Not in Commercial Distribution

  • 10888234500575 ()
404588

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent

Positive Platelet Control (Positive Eluate Control) - 10888234500568

For Use with PakAuto
IMMUCOR GTI DIAGNOSTICS, INC.
404579
Not in Commercial Distribution

  • 10888234500568 ()
404579

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent

Normal Platelet Control (Negative Eluate Control) - 10888234500551

For Use with PakAuto
IMMUCOR GTI DIAGNOSTICS, INC.
404578
Not in Commercial Distribution

  • 10888234500551 ()
404578

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent

Negative Serum Control - 10888234500544

For Use with PakPlus
IMMUCOR GTI DIAGNOSTICS, INC.
404577
Not in Commercial Distribution

  • 10888234500544 ()
404577

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent

Negative Serum Control - 10888234500537

For Use with PakAuto
IMMUCOR GTI DIAGNOSTICS, INC.
404576
Not in Commercial Distribution

  • 10888234500537 ()
404576

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent

Negative Serum Control - 10888234500520

For Use with Pak2-LE
IMMUCOR GTI DIAGNOSTICS, INC.
404574
Not in Commercial Distribution

  • 10888234500520 ()
404574

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent

Negative Serum Control - 10888234500513

For Use with Pak12G
IMMUCOR GTI DIAGNOSTICS, INC.
404573
Not in Commercial Distribution

  • 10888234500513 ()
404573

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent

Negative Serum Control - 10888234500506

For Use with Pak12
IMMUCOR GTI DIAGNOSTICS, INC.
404572
Not in Commercial Distribution

  • 10888234500506 ()
404572

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent

Eluting Solution - 10888234500490

For Use with PakAuto
IMMUCOR GTI DIAGNOSTICS, INC.
404565
Not in Commercial Distribution

  • 10888234500490 ()
404565

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent

Buffering Solution - 10888234500476

For Use with PakAuto
IMMUCOR GTI DIAGNOSTICS, INC.
404560
Not in Commercial Distribution

  • 10888234500476 ()
404560

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent

Anti-Human IgG Conjugate - 10888234500469

For Use with Pak2-LE
IMMUCOR GTI DIAGNOSTICS, INC.
404558
Not in Commercial Distribution

  • 10888234500469 ()
404558

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent

Anti-Human IgG Conjugate - 10888234500452

For Use with Pak12G
IMMUCOR GTI DIAGNOSTICS, INC.
404557
Not in Commercial Distribution

  • 10888234500452 ()
404557

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent

Welly - 00372663171053

Bandages with TA ointment
WELLY HEALTH PBC
WLY1027
In Commercial Distribution

  • 00372663171053 ()


  • First aid kit, medicated

T-handle - 04250337104841

T-Handle with Torque Limiter
Joimax GmbH
JMPS1022ST
In Commercial Distribution

  • 04250337104841 ()
JMPS1022ST

  • Surgical instrument handle, non-torque-limiting

NA - 04250321526260

Macro instrument, with HF
Söring GmbH
94-101-HF
Not in Commercial Distribution

  • 04250321526260 ()

  • Outer Diameter: 3.3 Millimeter
  • Length: 42 Millimeter


  • Soft-tissue ultrasonic surgical system handpiece, reusable

NA - 04250321519699

Macro instrument, with HF
Söring GmbH
94-106-HF
Not in Commercial Distribution

  • 04250321519699 ()

  • Outer Diameter: 2.2 Millimeter
  • Length: 48 Millimeter


  • Soft-tissue ultrasonic surgical system handpiece, reusable

Indian Knife - 04250337120476

Indian Knife with handle
Joimax GmbH
IK150610
In Commercial Distribution

  • 04250337120476 ()

  • WL 150 mm / OD 3.5 mm / F 6.2 mm / JL 10 mm
IK150610

  • Bone lever/elevator, reusable

iLESSYS® - 04250337117360

Working Tube with handle
Joimax GmbH
WTS127507
In Commercial Distribution

  • 04250337117360 ()

  • L 125 mm / ID 6.5 mm / OD 7.5 mm
WTS127507

  • Endoscope sheath, reusable

iLESSYS® - 04250337110279

Working Tube with Handle
Joimax GmbH
WTS127007
In Commercial Distribution

  • 04250337110279 ()

  • L 124 mm / ID 6.0 mm / OD 7.0 mm
WTS127007

  • Endoscope sheath, reusable

Forceps - 04250337109785

Hook Punch with Scoop
Joimax GmbH
SJP132714
In Commercial Distribution

  • 04250337109785 ()

  • L 130 mm / OD 2.7 mm / JL 5 mm, LOPS
SJP132714

  • Flexible endoscopic biopsy forceps, reusable

chisel - 04250337117780

Endo-Chisel with handle, curved
Joimax GmbH
TEC372620.
In Commercial Distribution

  • 04250337117780 ()

  • WL 330 mm / OD 2.60 mm
TEC372620.

  • Orthopaedic chisel

EON - 00366975013323

Eon Desensitizer with Glutaraldehyde
BENCO DENTAL SUPPLY CO.
5146-567
In Commercial Distribution

  • 00366975013323 ()


  • Dental coating, tooth-desensitizing

Ceramco® 3 - D0013016050

With Powder Opaque Kit
Dentsply International Inc.
16 Shade Basic System
Not in Commercial Distribution

  • D0013016050 ()
301605

  • Dental appliance fabrication material, ceramic

Ceramco® 3 - D0013016040

With Paste Opaque Kit
Dentsply International Inc.
16 Shade Basic System
Not in Commercial Distribution

  • D0013016040 ()
301604

  • Dental appliance fabrication material, ceramic
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