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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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Welch Allyn 3.5 V Halogen HPX Ophthalmoscope Set with Coaxial Ophthalmoscope (#11720), Rechargeable 60-Minute Power Handle(s) -- C-C ell Convertible, Hard Storage Case; Nickel-Cadmium (#72300) Battery; IEC Plug Type-A
WELCH ALLYN, INC.
901081
In Commercial Distribution

  • 00732094089417 ()
11770

  • Ophthalmic/otologic diagnostic set
Light Bond™ sealants are intended for use as a light cure sealant resin for bonding under an orthodontic adhesive. This is the 3 cc Filled Sealant Resin with Fluoride.
RELIANCE ORTHODONTIC PRODUCTS INC
LBFSF
In Commercial Distribution

  • D798LBFSF0 ()
LBFSF

  • Dental composite resin
No Description
BIOMET SPINE LLC
14-524506
In Commercial Distribution

  • 00888480609247 ()

  • LINEUM 4.0MM X 6MM CC SCREW TRANSLATING SCREW LINEUM OCT SPINE SYSTEM
14-524506

  • Bone-screw internal spinal fixation system, non-sterile
Urinary prosthesis, female, non-surgical
VESIFLO INC
Sep 2016
Not in Commercial Distribution

  • 08625630003027 ()

  • Length: 30 Millimeter
  • Length: 35 Millimeter
  • Length: 40 Millimeter
  • Length: 45 Millimeter
  • Length: 50 Millimeter
  • Length: 55 Millimeter
  • Length: 60 Millimeter
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=man203511

  • Intraurethral valve/pump
ENHANCED ALGORITHM ECG EVENT RECORDER
BRAEMAR MANUFACTURING, LLC
900-0557-06
In Commercial Distribution

  • B146ER9R0 ()
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&

  • Electrocardiography telemetric monitoring system
One time use sterile emergency airway kit that contains (1) Disposable Scalpel #10 blade, (1) Endotracheal Tube, 6.0 mm cuffed, (1) 10 cc syringe, (1) 35 cm Bougie and Twill Tape.
H&H MEDICAL CORPORATION
Version 5
In Commercial Distribution

  • 00857048006477 ()

  • Length: 9.25 Inch
  • Width: 4.0 Inch
  • Height: 1.75 Inch
HHRCK01

  • Cricothyrotomy kit, single-use
No Description
ALIMED, INC.
910439ZBW
In Commercial Distribution

  • 00733657259322 ()
2970011582

  • Operating table mattress, basic
No Description
ALIMED, INC.
910432ZBW
In Commercial Distribution

  • 00733657259308 ()
2970011578

  • Operating table mattress, basic
No Description
ALIMED, INC.
910435ZBW
In Commercial Distribution

  • 00733657232998 ()
2970011580

  • Operating table mattress, basic
106900 Connex Server Application Software – Includes 2 thumb drives, one Production, one Test, with included software app, installer and Proview – Includes one ADT <(>&<)> one ORU production license, one ADT <(>&<)> one ORU test license – Includes 5 connectivity device test licenses – Includes Connex CS 1.8x DFU
WELCH ALLYN, INC.
901066
In Commercial Distribution

  • 00732094244298 ()
106900

  • Centralized patient monitor
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