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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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LSR Silicone Mask No.00 - 07045430012257

Laerdal Silicone Masks are intended to be used for ventilation of patients. The multi-function Mask Cover is intended to be used to add additional support, when needed, to Laerdal Silisone Masks (sizes 3-4, 4-5+) and to allow for strapping of Laerdal Silicone Masks to the patient.
Laerdal Medical AS
851500
In Commercial Distribution

  • 07045430012257 ()
851500

  • Resuscitator face mask, reusable

Regulated Software Application (RSA) - 00860003545409

The Regulated Software Application (RSA) is a system of co-dependent web based computer programs, used to manage and support all aspects of the blood banking process.
ARC-ONE SOLUTIONS, LLC
1.0.33.0
Not in Commercial Distribution

  • 00860003545409 ()
1.0.33.0

  • Blood bank information system application software

Original Penguin - 00715317025768

The Leopold Jr Surf the Web Blue Spectacle
Kenmark Optical, Inc.
LEJRBL48
In Commercial Distribution

  • 00715317025768 ()


  • Prescription spectacles

Automate - 05902729753654

DentalSystem-backed web service for automatic designs of crowns.
3shape Trios A/S
R1.0
Not in Commercial Distribution

  • 05902729753654 ()


  • Dental treatment application software

Young - 00302730002706

DPA DHP / GR UNIV / WHT 4 WEB / 500CT
YOUNG DENTAL MANUFACTURING I, LLC
295018
In Commercial Distribution

  • 10302730002703 ()
  • 00302730002706 ()
  • 20302730002700 ()
295018

  • Dental polishing cup, single-use

Young - 00302730002690

DPA DHP / GR UNIV / GRY 4 WEB / 500CT
YOUNG DENTAL MANUFACTURING I, LLC
295017
In Commercial Distribution

  • 10302730002697 ()
  • 00302730002690 ()
  • 20302730002694 ()
295017

  • Dental polishing cup, single-use

Spine Instruments - 07630971267008

T handle Fast web A ratcheting old style
Medacta International SA
03.51.10.0621
In Commercial Distribution

  • 07630971267008 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

Spine Instruments - 07630971266995

Straight handle Fast web A ratcheting old style
Medacta International SA
03.51.10.0620
In Commercial Distribution

  • 07630971266995 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

LEONE SPA - 08033707085461

WEB I MOL BANDS G8424-17+G2820-00 KIT LL
LEONE SPA
E8971-92
In Commercial Distribution

  • 08033707085461 ()
E8971-92

  • Orthodontic metal band

LEONE SPA - 08033707085454

WEB I MOL BANDS G8424-17+G2820-00 KIT LL
LEONE SPA
E8971-90
In Commercial Distribution

  • 08033707085454 ()
E8971-90

  • Orthodontic metal band
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