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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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MedSource IV Start Kit - 00816703022665

I.V. Start Kit with Site-Loc Transparent Dressing, 8 ext Set, Prevantics Wipe
MEDSOURCE INTERNATIONAL LLC
MS-80047P
In Commercial Distribution

  • 00816703022672 ()
  • 00816703022665 ()
Not Applicable

  • Peripheral intravenous catheterization support kit

Modulap - 00817428020127

ASU1245T Laparoscopic irrigation/aspiration cannula; 5mm x45cm (bariatric length) with holes, reusable
ATC TECHNOLOGIES, INC.
ASU1245T
In Commercial Distribution

  • 00817428020127 ()


  • Laparoscopic irrigation/aspiration cannula

Lithotripsy Probe 1.9FR 375cm DS - 00817183020448

1.9FR 375cm DS Lithotripsy Probe for use with Autolith Touch Lithotripters, BSC
NORTHGATE TECHNOLOGIES INC.
M00546620
In Commercial Distribution

  • 00817183020448 ()


  • Electrohydraulic/pneumatic lithotripsy system probe, salivary, single-use

GYRUS ACMI, INC - 00821925041387

PENTAX LIGHT SOURCE CONNECTOR FOR USE WITH GYRUS ENT FLEXIBLE AND RIG
Gyrus ACMI, LLC
70230946
Not in Commercial Distribution

  • 00821925041387 ()


  • Endoscopic light source adaptor

AMSure® Specimen Cup - 10704411008415

AMSure® Specimen Cup CONTENTS: 4 oz Graduated Cup with Screw Cap
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 10704411008415 ()
  • 40704411008416 ()
AS345

  • Sputum specimen container IVD

AMSure® Specimen Container - 10704411008392

AMSure® Specimen Container CONTENT: Non-Toxic4 oz./120cc with Tamper Evident Label
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 10704411008392 ()
  • 40704411008393 ()
AS341

  • Sputum specimen container IVD

Smartdop XT - 00894912002852

Vascular Doppler system for arterial and venous testing capabilities with Smart-XT-Link software.
KOVEN TECHNOLOGY, INC.
Smartdop XT
In Commercial Distribution

  • 00894912002852 ()
Smartdop XT

  • Noninvasive vascular ultrasound system, line-powered

CODMAN SOFWIRE - 10705034002286

CODMAN SOFWIRE SS Ti Single Cable with Leader, 1 Cinch, 1 Tightener
Cerenovus, Inc.
46-4040
Not in Commercial Distribution

  • 10705034002286 ()
464040

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile

Rumex - 00840159909027

Helveston Finder Hook, Extra Delicate with Lightly Angled Cone Shaped Tip, Large
RUMEX INTERNATIONAL CORP.
5-045
In Commercial Distribution

  • 00840159909027 ()
5-045

  • Ocular hook/spatula/manipulator, reusable

Rumex - 00840159906651

Quick Chopper With Rounded Edge, LHD, Length 120 mm, Round Titanium Handle
RUMEX INTERNATIONAL CORP.
7-1281
In Commercial Distribution

  • 00840159906651 ()
7-1281

  • Ocular hook/spatula/manipulator, reusable
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