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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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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

EON - 00366975013323

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

  • 00366975013323 ()


  • Dental coating, tooth-desensitizing

ELMED - 00842180172722

HANDLE WITH QUICK COUPLING
ELMED INCORPORATED
23-31143
In Commercial Distribution

  • 00842180172722 ()
23-31143

  • Arthroscopic surgical procedure kit, non-medicated, reusable

n.a. - 04250105620184

Bi-Mask with silicone lip
VBM Medizintechnik GmbH
35-65-222
In Commercial Distribution

  • 04250105620184 ()


  • Anaesthesia face mask, reusable

n.a. - 04250105605518

Biteblock with elastic necktape
VBM Medizintechnik GmbH
40-76-050
In Commercial Distribution

  • 14250105605515 ()
  • 04250105605518 ()

  • #5 ; suitable for ET Tubes: 8.5 - 11.0 mm / Laryngeal Tubes: LT / LTS II #2, #2.5 / Laryngeal Masks: # 2, #2.5


  • Oropharyngeal airway, reusable

n.a. - 04250105605501

Biteblock with elastic necktape
VBM Medizintechnik GmbH
40-76-060
In Commercial Distribution

  • 14250105605508 ()
  • 04250105605501 ()

  • #6 ; suitable for Laryngeal Tubes: LT / LTS II #3, #4, #5 / Laryngeal Masks: #3, #4, #5


  • Oropharyngeal airway, reusable

n.a. - 04250105608854

Bi-Mask with silicone lip
VBM Medizintechnik GmbH
35-65-226
In Commercial Distribution

  • 04250105608854 ()

  • #6 ; 22 mm I.D.


  • Anaesthesia face mask, reusable

n.a. - 04250105608847

Bi-Mask with silicone lip
VBM Medizintechnik GmbH
35-65-225
In Commercial Distribution

  • 04250105608847 ()

  • #5 ; 22 mm I.D.


  • Anaesthesia face mask, reusable

n.a. - 04250105608830

Bi-Mask with silicone lip
VBM Medizintechnik GmbH
35-65-224
In Commercial Distribution

  • 04250105608830 ()

  • #4 ; 22 mm I.D.


  • Anaesthesia face mask, reusable

n.a. - 04250105608823

Bi-Mask with silicone lip
VBM Medizintechnik GmbH
35-65-223
In Commercial Distribution

  • 04250105608823 ()

  • #3 ; 22 mm I.D.


  • Anaesthesia face mask, reusable

Natus® - 00382830056861

Pudenz Catheter with Stylet
NATUS MEDICAL INCORPORATED
NT8501228
In Commercial Distribution


  • Tubing: 1.3mm I.D. x 2.5mm O.D.; Total Length: 18cm (7") (all dimensions nominal)
NT8501228

  • Intracerebral infusion/drainage catheter, long-term

Natus - 00382830056335

RetCam Envision with FA
XLTEK
61-000300
In Commercial Distribution

  • 00382830056335 ()


  • Ophthalmic fundus camera

Alamo C - M6861412T400S0

Inserter with Stop Instrument
ALLIANCE PARTNERS LLC
1412T-400-S
In Commercial Distribution

  • M6861412T400S0 ()
1412T-400-S

  • Orthopaedic inorganic implant inserter/extractor, reusable

CARDINAL HEALTH - 10888439092363

LAMINECTOMY WITH BASIN PK
Cardinal Health 200, LLC
SNE69LMEC1
In Commercial Distribution

  • 50888439092361 ()
  • 10888439092363 ()
SNE69LMEC1

  • Neurosurgical procedure kit, non-medicated, single-use

Tandem Mobi Starter Kit - 00389152311777

with Control-IQ 7.X
Tandem Diabetes Care, Inc.
1013117
In Commercial Distribution

  • 00389152311777 ()


  • Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm

Senti - 04260223142529

Senti device with touchscreen
PATH medical GmbH
100097
Not in Commercial Distribution

  • 04260223142529 ()


  • Tone audiometer

MaxMoreSpine - 04260200313867

BESS Tray with lid
Hoogland Spine Products GmbH
1001-IS 014
In Commercial Distribution

  • 04260200313867 ()


  • Instrument tray, reusable

MaxMoreSpine - 04260200312631

MaxDisc Tray with lid
Hoogland Spine Products GmbH
1001-IS 011
In Commercial Distribution

  • 04260200312631 ()


  • Instrument tray, reusable
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