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

  • 00366975013323 ()


  • Dental coating, tooth-desensitizing
HANDLE WITH QUICK COUPLING
ELMED INCORPORATED
23-31143
In Commercial Distribution

  • 00842180172722 ()
23-31143

  • Arthroscopic surgical procedure kit, non-medicated, reusable
Bi-Mask with silicone lip
VBM Medizintechnik GmbH
35-65-222
In Commercial Distribution

  • 04250105620184 ()


  • Anaesthesia face mask, reusable
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
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
Bi-Mask with silicone lip
VBM Medizintechnik GmbH
35-65-226
In Commercial Distribution

  • 04250105608854 ()

  • #6 ; 22 mm I.D.


  • Anaesthesia face mask, reusable
Bi-Mask with silicone lip
VBM Medizintechnik GmbH
35-65-225
In Commercial Distribution

  • 04250105608847 ()

  • #5 ; 22 mm I.D.


  • Anaesthesia face mask, reusable
Bi-Mask with silicone lip
VBM Medizintechnik GmbH
35-65-224
In Commercial Distribution

  • 04250105608830 ()

  • #4 ; 22 mm I.D.


  • Anaesthesia face mask, reusable
Bi-Mask with silicone lip
VBM Medizintechnik GmbH
35-65-223
In Commercial Distribution

  • 04250105608823 ()

  • #3 ; 22 mm I.D.


  • Anaesthesia face mask, reusable
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
RetCam Envision with FA
XLTEK
61-000300
In Commercial Distribution

  • 00382830056335 ()


  • Ophthalmic fundus camera
Inserter with Stop Instrument
ALLIANCE PARTNERS LLC
1412T-400-S
In Commercial Distribution

  • M6861412T400S0 ()
1412T-400-S

  • Orthopaedic inorganic implant inserter/extractor, reusable
LAMINECTOMY WITH BASIN PK
Cardinal Health 200, LLC
SNE69LMEC1
In Commercial Distribution

  • 50888439092361 ()
  • 10888439092363 ()
SNE69LMEC1

  • Neurosurgical procedure kit, non-medicated, single-use
with Control-IQ 7.X
Tandem Diabetes Care, Inc.
1013117
In Commercial Distribution

  • 00389152311777 ()


  • Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm
Senti device with touchscreen
PATH medical GmbH
100097
Not in Commercial Distribution

  • 04260223142529 ()


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

  • 04260200313867 ()


  • Instrument tray, reusable
MaxDisc Tray with lid
Hoogland Spine Products GmbH
1001-IS 011
In Commercial Distribution

  • 04260200312631 ()


  • Instrument tray, reusable
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