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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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One time use sterile emergency airway kit that contains (1) Disposable Scalpel #10 blade, (1) Endotracheal Tube, 6.0 mm cuffed, (1) Curved Crile Hemostat, (1) News Tracheal Hook, (1) 10 cc syringe, (1) 35 cm Bougie and Twill Tape.
H&H MEDICAL CORPORATION
Version 5
In Commercial Distribution

  • 00857048006002 ()

  • Height: 1.75 Inch
  • Width: 4.0 Inch
  • Length: 9.25 Inch
HHECT01

  • Cricothyrotomy kit, single-use
The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by dental professionals. uDesign imports patient 3-D digital scans and allows the user to diagnose the orthodontic treatment needs of the patient and rapidly develop a treatment plan. The output of the treatment plan may be downloaded as files in standard stereolithographic (STL) format for fabrication of dental casts, which may be used to fabricate sequential aligner trays or retainers
Ulab Systems, Inc.
Version 5
Not in Commercial Distribution

  • 00860002380001 ()
FG0064

  • Dental milling system, CAD/CAM, laboratory
Calcium compound bone void filler (5 cc)
Vivorte, Inc
5 cc
In Commercial Distribution

  • 00868201000171 ()
131133-05-S

  • Bone matrix implant, synthetic, non-antimicrobial
Calcium compound bone void filler (5 cc)
Vivorte, Inc
5 cc
Not in Commercial Distribution

  • 00868201000140 ()


  • Bone matrix implant, synthetic, non-antimicrobial
Calcium compound bone void filler (5 cc)
Vivorte, Inc
5 cc
Not in Commercial Distribution

  • 00868201000119 ()
131133-05

  • Bone matrix implant, synthetic, non-antimicrobial
Vac Abdominal Dressing Featuring Sensatrac Technology
KCI USA, INC.
M8275080/5
In Commercial Distribution

  • 00878237001325 ()


  • Negative-pressure wound therapy open-abdomen dressing
Dilator of uterine cervix
MEDGYN PRODUCTS, INC.
size 5
In Commercial Distribution

  • M803021005 ()
021005

  • Hygroscopic cervical dilator
Nasal Implant
IMPLANTECH ASSOCIATES, INC.
Size 5
In Commercial Distribution

  • M724400754S1 ()
400-754S

  • Nasal cartilage support implant, non-bioabsorbable
Nasal Implant
IMPLANTECH ASSOCIATES, INC.
Size 5
In Commercial Distribution

  • M724400654S1 ()
400-654S

  • Nasal cartilage support implant, non-bioabsorbable
Chin Implant
IMPLANTECH ASSOCIATES, INC.
Size 5
In Commercial Distribution

  • M724250854S1 ()
250-854S

  • Chin prosthesis
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