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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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Barrier Wrap with Support Apron. Provides full wrap around protection against direct & scatter radiation. One-piece desgin enables easy-on & easy-off. Fully adjustable integrated back support belt provides maximum support to the lower lumbar region. UltraFlex material. Black color. Size small. Thyroid collar included.
Barrier Technologies, LLC
BWSP-.5mmPbF-SM-UF-BLK
In Commercial Distribution

  • 00850035588000 ()


  • Radiation shielding apron
A Kit with 5 products including Tweakz for Aligners, comfort tape, mouth-aid, OrthoChewz and Chillin’ Strips.
Orthonu LLC
0850035489
In Commercial Distribution

  • 00850035489079 ()
ORN0006-03

  • Dental restoration/appliance emergency fix kit
A Kit with 4 products including comfort tape, mouth-aid, OrthoChewz and Chillin’ Strips.
Orthonu LLC
850035489055
In Commercial Distribution

  • 00850035489055 ()
ORN0006-01

  • Dental restoration/appliance emergency fix kit
A compound intended to be used as a protective cover for the general mucosa to treat sores and ulcers.
Orthonu LLC
850035489031
In Commercial Distribution

ORN0005-01

  • General oral wound dressing, non-animal-derived
No Description
Orthonu LLC
ORN0002-01
In Commercial Distribution

  • 00850035489017 ()


  • Margin finishing dental file/rasp, reusable
No Description
Orthonu LLC
ORN0001-01
In Commercial Distribution

  • 00850035489000 ()


  • Orthodontic pliers
A comprehensive screening kit that analyzes key hormone factors related to fertility. Contains 3 FSH urine tests to check ovarian reserve, 10 LH tests to predict ovulation during the fertile window, and 5 PdG tests to confirm ovulation during the implantation window.
Mfb Fertility, Inc.
Fertility 3-in-1 Test
In Commercial Distribution

  • 00850035206157 ()


  • Natural conception assistance kit
A comprehensive at home fertility test that measures four key hormones that impact your cycle and fertility.
Mfb Fertility, Inc.
Complete
In Commercial Distribution

  • 00850035206065 ()


  • Natural conception assistance kit
Resvent iBreeze Disposable CPAP Filter - 2/pk
SUNSET HEALTHCARE SOLUTIONS, INC.
ASNU001CF9901-2
In Commercial Distribution

  • 00850035116425 ()


  • CPAP/BPAP unit ambient air filter, single-use
Halo Style Chinstrap
SUNSET HEALTHCARE SOLUTIONS, INC.
ASNU001CS025
In Commercial Distribution

  • 00850035116371 ()


  • CPAP/BPAP chin strap, reusable
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