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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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Intracranial Dual lumen bolt kit with introducer
HEMEDEX, INC
NA
In Commercial Distribution

  • B238H000036420 ()
H0000-3642

  • Intracerebral catheter cranial-fixation kit
Zephyr Accessory, Patient Stirrups with rail clamps
Diacor, Inc.
ZEP-APS-10
In Commercial Distribution

  • B237ZEPAPS100 ()


  • Patient lifting system stretcher
Zephyr Accessory, Patient Stirrups with rail clamps
Diacor, Inc.
ZEP-APS-01
Not in Commercial Distribution

  • B237ZEPAPS010 ()


  • Patient transfer system, powered
TEC with Fagron Logo. Tray of 10
INTERNATIONAL MEDICAL INDUSTRIES INC.
57-302 FSS
In Commercial Distribution

  • B21257302FSS10 ()
  • B21257302FSS1 ()
57-302 FSS

  • Luer-formatted protective cap
Full Shape II system with paramagnetic analyzer
Shape Medical Systems, Inc.
0012-9012
In Commercial Distribution

  • B2009012 ()


  • Pulmonary function analysis system, adult
Full Shape II system with paramagnetic analyzer
Shape Medical Systems, Inc.
0008-3012
In Commercial Distribution

  • B20083012 ()


  • Pulmonary function analysis system, adult
LIFE®CPR Mask with one-way valve.
Mv Life LLC
LIFE-100
In Commercial Distribution

  • B188LIFE1000 ()


  • Cardiopulmonary resuscitation mask, single-use
No. 4 pad with wings bulk packed
IMPACT PRODUCTS, LLC
25189990
In Commercial Distribution

  • B34025189990 ()
25189990

  • Menstrual pad, unscented
T-Ratchet Handle with Impact Cap (Black Handle)
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GL201TIB0 ()
GL201TI-B

  • Bone-screw internal spinal fixation system, non-sterile
Life L-Column Arm with Low Profile Attachment
Life Instrument Corporation
703-1803-0
In Commercial Distribution

  • M930703180300 ()


  • Surgical instrument assist arm system, manually-adjusted
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