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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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Ceph attachment with sensor
MIDMARK CORPORATION
C6000
In Commercial Distribution

  • 00841709102752 ()
C6000

  • Stationary cephalometric x-ray system, digital
Cross Bar with Clamp Assembly
KOROS U.S.A., INC.
8760-20
In Commercial Distribution

  • 00840199536634 ()
  • 10840199536631 ()

  • 9x12mm
8760-20

  • Self-retaining surgical retractor, reusable
No Description
Biomet Orthopedics, LLC
903719
In Commercial Distribution

  • 00887868569920 ()
903719

  • Bone file/rasp, manual, reusable
No Description
ELECTRO-CAP INTERNATIONAL INC
E2S-21WIRE
In Commercial Distribution

  • 00811478011722 ()
E2S-21WIRE

  • Analytical scalp lead
No Description
Gulden Ophthalmics Inc.
1
In Commercial Distribution

  • B091151600 ()


  • Trial lens set
"Genesis MNS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart and coronary vasculature, neurovascular and peripheral vasculature by orienting the device tip in a desired direction. "
Stereotaxis, Inc.
1.1 Model-S
In Commercial Distribution

  • M58800101100030 ()
001-011000-3

  • Robotic surgical navigation system
No Description
Biomet Orthopedics, LLC
110008463
In Commercial Distribution

  • 00887868131646 ()

  • 5.0MM
110008463

  • Surgical depth gauge, reusable
No Description
Biomet Orthopedics, LLC
A11
In Commercial Distribution

  • 00887868070310 ()
A11

  • External orthopaedic fixation system, single-use
No Description
Biomet Orthopedics, LLC
939999587
In Commercial Distribution

  • 00887868068836 ()

  • 3.5MM
939999587

  • Bone tap, reusable
No Description
Biomet Orthopedics, LLC
110008463
In Commercial Distribution

  • 00887868463211 ()

  • 5.0 mm
110008463

  • Surgical depth gauge, reusable
Navient System 955-NC-NC with kits
ClaroNav Kolahi Inc
955-NC-NC
In Commercial Distribution

  • 07540209955501 ()


  • Neurological stereotactic surgery system
Navient ENT system with kit
ClaroNav Kolahi Inc
955-NE-NE
In Commercial Distribution

  • 07540209955112 ()


  • Neurological stereotactic surgery system
AEROBIKA OPEP with Manometer (package of 10)
Trudell Medical International
110504
Not in Commercial Distribution

  • 62860110504023 ()
  • 62860110504016 ()
11050494010

  • Positive pressure airway secretion-clearing device
Perpos PLS System Compression Tool
INTERVENTIONAL SPINE, INC
9049
In Commercial Distribution

  • 81195401012686 ()
9049-00

  • Bone-nailing compression screw
No Description
CAYENNE MEDICAL, INC.
CM9640S
In Commercial Distribution

CM9640S

  • Fluted surgical drill bit, reusable
No Description
CAYENNE MEDICAL, INC.
CM9620S
In Commercial Distribution

CM9620S

  • Fluted surgical drill bit, reusable
Holder with standard rail for attachment of powered suction pump (e.g Invia Liberty or Thopaz)
Medela AG
079.0036
In Commercial Distribution

  • 07612367016339 ()


  • Medical device service rail clamp
Sil-Select Stock with gentamicin - SIS100_32G (100 ml) Sil-Select Stock™ is a solution of silane-coated sicila particles in a chemically defined, balanced salts solution with HEPES (pH buffer). Sil-Select Stock has a 18 month shelf life from date of manufacturer For the latest version of the intructions for use and MSDS, visit our product page on the FertiPro's website (www.fertipro.com)
Fertipro NV
SIS100G (100ml with gentamicin)
Not in Commercial Distribution

  • 54119670012860 ()
  • 05411967000654 ()

  • Total Volume: 100 Milliliter


  • IVF medium
~110 in. (280 cm) - yellow stripe, For Use with the BodyGuard® Infusion Pump
CME AMERICA LLC
A100-163XSFL
Not in Commercial Distribution

  • B101A100163XSFL0 ()
  • B101A100163XSFL1 ()


  • Electric infusion pump administration set, single-use
Dermatocope with polarized filter
BELLEGROVE MEDICAL SUPPLY, INC.
BTS-313
Not in Commercial Distribution

  • B1623131 ()
FEDMEDICFIUVWP_US

  • Otoscope, direct
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