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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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ColoSense Collection Kit - 00198715728941

Device is a stool collection kit for at-home use.
Geneoscopy, Inc.
0
In Commercial Distribution

  • 00198715728941 ()


  • Faecal specimen collection kit IVD, home-use

XP DISPOSABLE LARYNGOSCOPE BLADE MILLER - 04053755129195

No Description
Heine Optotechnik GmbH & Co. KG
0
In Commercial Distribution

  • 04053755129195 ()
F-000.22.771

  • Laryngoscope blade, single-use

CLASSIC+ LARYNGOSCOPE BLADE PAED - 04053755200337

No Description
Heine Optotechnik GmbH & Co. KG
0
In Commercial Distribution

  • 04053755200337 ()
F-000.22.110

  • Laryngoscope blade, reusable

CLASSIC+ LARYNGOSCOPE BLADE MILLER - 04053755200252

No Description
Heine Optotechnik GmbH & Co. KG
0
In Commercial Distribution

  • 04053755200252 ()
F-000.22.120

  • Laryngoscope blade, reusable

CLASSIC+ LARYNGOSCOPE BLADE MAC - 04053755200177

No Description
Heine Optotechnik GmbH & Co. KG
0
In Commercial Distribution

  • 04053755200177 ()
F-000.22.100

  • Laryngoscope blade, reusable

NAMIC - H9656006056100

NAMIC Convenience Kit
NAVILYST MEDICAL, INC.
0
In Commercial Distribution

  • H9656006056101 ()
  • H9656006056100 ()


  • Angiography kit

SideStream - 00383730001258

SideStream Reusable and Tuck Mask PT PK, 50 pack.
RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD
0
In Commercial Distribution

  • 00383730001258 ()
1101484

  • Benchtop nebulizer, non-heated

SideStream - 00383730001234

SideStream Reusable Retail Kit, 10-pack
RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD
0
In Commercial Distribution

  • 00383730001234 ()
1072299

  • Benchtop nebulizer, non-heated

THRESHOLD - 00383730001029

Threshold IMT (730EU) Single Unit.
RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD
0
In Commercial Distribution

  • 00383730001029 ()
HS730EU-001

  • Incentive spirometer

SYSTEM 22 - 00383730004259

SYSTEM 22 PEDIATRIC AEROSOL MSK SUB ASSY
RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD
0
In Commercial Distribution

  • 00383730004259 ()
1050430

  • Aerosol face mask, rebreathing, single-use

I-neb - 00383730003740

I-neb PH20 Gold Dosing Kit.
RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD
0
In Commercial Distribution

  • 00383730003740 ()
1119498

  • Ultrasonic nebulizing system

InnoSpire Elegance - 00383730003399

Innospire Elegance, Custom Jayhawk Pharm, 6 pack.
RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD
0
In Commercial Distribution

  • 00383730003399 ()
1106290

  • Benchtop nebulizer, non-heated

SIDESTREAM - 00383730001241

Sidestream Reusable Nebulizers [2], 12-pack
RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD
0
In Commercial Distribution

  • 00383730001241 ()
1074386

  • Benchtop nebulizer, non-heated

Walser® Plastoferm-Löffel F - 04262363910785

No Description
Dr. Walser Dental GmbH
0
Not in Commercial Distribution

  • 04262363910785 ()


  • Dental impression material kit, single-use

Walser® Plastoferm-Löffel L - 04262363910778

No Description
Dr. Walser Dental GmbH
0
Not in Commercial Distribution

  • 04262363910778 ()


  • Dental impression material kit, single-use

Walser® Injecto-Löffel - 04262363910761

No Description
Dr. Walser Dental GmbH
0
Not in Commercial Distribution

  • 04262363910761 ()


  • Dental impression material kit, single-use

Walser® MPI Löffel - 04262363910754

No Description
Dr. Walser Dental GmbH
0
Not in Commercial Distribution

  • 04262363910754 ()


  • Dental impression material kit, single-use

Self-Adhesive Electrode 2" x 4" Pro Pulse HD - B243PSSA2X4PP4

Self-Adhesive Electrode
ELECTRO MEDICAL TECHNOLOGIES, LLC
0
Not in Commercial Distribution

  • B243PSSA2X4PP4 ()


  • Transdermal medication patch

Self-Adhesive Electrode 2" x 2" Pro Pulse HD - B243PSSA2X2PP4

Self-Adhesive Electrode
ELECTRO MEDICAL TECHNOLOGIES, LLC
0
Not in Commercial Distribution

  • B243PSSA2X2PP4 ()


  • Transcutaneous electrical stimulation electrode, single-use

Carbon-Rubber Electrodes (2" Round) - B243PSRCR552

No Description
ELECTRO MEDICAL TECHNOLOGIES, LLC
0
In Commercial Distribution

  • B243PSRCR552 ()


  • Transcutaneous electrical stimulation electrode, single-use
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