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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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ACIF Interbody System Instruments - M6950CR0001210

Cervical Inserter with Impaction Cap
Tyber Medical LLC
0CR-000121
In Commercial Distribution

  • M6950CR0001210 ()
0CR-000121

  • Metal-polymer composite spinal interbody fusion cage

Orthex - 00841731114747

Orthex Strut Diagonal with QC
VILEX IN TENNESSEE, INC.
390-045-Q
In Commercial Distribution

  • 00841731114747 ()


  • External orthopaedic fixation system, single-use

Orthex - 00841731112507

Orthex Pin Bolt with washer
VILEX IN TENNESSEE, INC.
C660
In Commercial Distribution

  • 00841731112507 ()
C660

  • External orthopaedic fixation system, single-use

neon³™ OCT spinal stabilization - 04052536161454

Occipital plate, lateral, with rod
Ulrich GmbH & Co. KG
CS 3913-05
In Commercial Distribution

  • 04052536161454 ()
CS 3913-05

  • Spinal fixation plate, non-bioabsorbable

ZipFix - 10887587025971

STERNAL ZIPFIX WITH NEEDLE STERILE
Synthes GmbH
08.501.001.01S
In Commercial Distribution

  • H9800850100101S0 ()
  • 10887587025971 ()
0850100101S

  • Sternal fixation device

QUASAR Standalone ACIF System - 08809885799809

Angled Drill Tip with Sleeve
GS Medical Co., Ltd.
GS136-0200
In Commercial Distribution

  • 08809885799809 ()
GS136-0200

  • Polymeric spinal interbody fusion cage

Natus® - 00382830056991

Portnoy Ventricular Catheter With Stylet
NATUS MEDICAL INCORPORATED
NT8501229
In Commercial Distribution


  • 1.3mm I.D. x 2.2mm O.D.; Total Length: 18cm (7") (all dimensions nominal)
NT8501229

  • Intracerebral infusion/drainage catheter, long-term

Natus® - 00382830056984

Peritoneal Open-Ended Catheter With Slits
NATUS MEDICAL INCORPORATED
NT98003S01
In Commercial Distribution


  • Tubing: 1.3mm ID x 2.5mm OD; Total Length: 90 cm (35 1/2") (All dimensions nominal)
NT98003S01

  • Peritoneal/atrial cerebrospinal fluid catheter

Natus® - 00382830056977

Pudenz Open-Ended Catheter With Slits
NATUS MEDICAL INCORPORATED
NT8501376
In Commercial Distribution


  • Tubing: 1.3mm I.D. x 2.5mm O.D.; Total Length: 120cm (47 1/4") (All dimensions nominal)
NT8501376

  • Peritoneal/atrial cerebrospinal fluid catheter

Natus® - 00382830056908

Pudenz Ventricular Catheter with Stylet
NATUS MEDICAL INCORPORATED
NT8501519
In Commercial Distribution


  • Length from tip to 90 degree angle: 9cm; Tubing: 1.3mm I.D. x 2.5mm O.D. (All dimensions nominal)
NT8501519

  • Intracerebral infusion/drainage catheter, long-term
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