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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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SG1/2 GRA 1/2 #2 HDL 1P
Peter Brasseler Holdings, LLC
5023350U0
In Commercial Distribution

  • 00887919681472 ()


  • Periodontal curette
Custom Suture Pack,(2) 88863369-51;(3) CL-5-M;(2) CL-905;(2) CLS-843;(6) CS-424;(1) S-318;(2) SM-5678;(2) VP-557-X;(2) VP-581-X;(2) VP-761-X
Covidien LP
US1625
Not in Commercial Distribution

  • 20884521165363 ()
  • 10884521165366 ()


  • Suture kit, medicated
Kelly Retr 9 1/2" 2" x 2 1/2" loop hdl
GSOURCE LLC
gS 36.3180
In Commercial Distribution

  • 00840314213877 ()
gS 36.3180

  • Hand-held surgical retractor, reusable
Taylor Lam Blade 4 prgs 2 1/2" x 2 1/2"
GSOURCE LLC
gS 40.5750
In Commercial Distribution

  • 00840314217868 ()
gS 40.5750

  • Surgical retractor/retraction system blade, reusable
Custom Suture Pack, (4) 888864470-81, (2) GLS-322, (2) GLS-832, (2) GS-833, (2) S-303, (2) S-304, (3) S-305, (2) S-316, (2) SS-677, (2) VP-521-X, (4) VP-556-X, (4) VP-706-X
Covidien LP
US1711
Not in Commercial Distribution

  • 20884521582221 ()
  • 10884521582224 ()
US1711

  • Suture kit, medicated
Custom Suture Pack,(4) CN-825;(2) GLS-322;(2) GS-832;(2) GS-833;(2) S-303;(2) S-304;(3) S-305;(2) S-316;(2) SS-677;(2) VP-521-X;(4) VP-556-X;(4) VP-706-X
Covidien LP
US1596
Not in Commercial Distribution

  • 20884521161594 ()
  • 10884521161597 ()
US1596

  • Suture kit, medicated
The IceCaps are medical devices used as EEG electrodes. They are used by Healthcare Professionals on a patient in case of neurological disorders with a short or long-term EEG record (up to 72 hours). IceCap 2 shall be placed on patients weighing at least 10 kg (22.05 Ibs) and having a head circumference above 43 cm (16.93 inches). IceCap Neonate shall be placed on the head of babies, newborns and premature babies.
BIOSERENITY MEDICAL DEVICES GROUP
1001-01014-UN
In Commercial Distribution

  • 03615220003617 ()


  • Electroencephalographic electrode cap, single-use
No Description
NATIONAL BIOLOGICAL CORPORATION
UVB-241
In Commercial Distribution

  • 00816878020879 ()


  • Ultraviolet phototherapy unit, home-use
Secondary Dose Check for external beam radiation therapy.
DOSISOFT
2.0.2
In Commercial Distribution

  • B501THINKQA0200020 ()


  • Radiation therapy software
Secondary Dose Check for external beam radiation therapy.
DOSISOFT
2.0.1
In Commercial Distribution

  • B501THINKQA0200010 ()
TK2010, TK2020

  • Radiation therapy software
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