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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OMEGA XP™ 9MM X 28MM X 10MM 0° LUMBAR EXPANDABLE INTERBODY
SPINAL ELEMENTS
72-00-092810-00
In Commercial Distribution

  • 00840916124618 ()


  • Metallic spinal interbody fusion cage
OMEGA XP™ 9MM X 28MM X 8MM 0° LUMBAR EXPANDABLE INTERBODY
SPINAL ELEMENTS
72-00-092808-00
In Commercial Distribution

  • 00840916124601 ()


  • Metallic spinal interbody fusion cage
ARTICULATING RAKE W/ RATCHET
SPINAL ELEMENTS, INC.
SP-0539
In Commercial Distribution

  • 00840916148577 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
Heine Optotechnik GmbH & Co. KG
000
In Commercial Distribution

  • 04053755198382 ()
C-008.33.600

  • Indirect binocular ophthalmoscope
No Description
Heine Optotechnik GmbH & Co. KG
DV1 CAMERA
In Commercial Distribution

  • 04053755181704 ()
C-004.33.563

  • Indirect binocular ophthalmoscope
No Description
Heine Optotechnik GmbH & Co. KG
6 V
In Commercial Distribution

  • 04053755153541 ()
C-004.33.507

  • Indirect binocular ophthalmoscope
No Description
Provision
ZMS-4011
In Commercial Distribution

  • B504OMZMS40110 ()


  • Surgical saw blade, reciprocating, reprocessed
No Description
Provision
ZM-263
In Commercial Distribution

  • B504OMZM2630 ()


  • Surgical saw blade, reciprocating, reprocessed
No Description
Provision
SM-4011
In Commercial Distribution

  • B504OMSM40110 ()


  • Surgical saw blade, reciprocating, reprocessed
No Description
Provision
MR10MH30
In Commercial Distribution

  • B504OMMR10MH300 ()


  • Burring power tool attachment
OMEGA XP™ 9MM X 34MM X 8MM 0°
SPINAL ELEMENTS
72-00-093408-00
In Commercial Distribution

  • 00840916133221 ()


  • Metallic spinal interbody fusion cage
OMEGA XP™ 9MM X 28MM X 11MM 11°
SPINAL ELEMENTS
72-00-092811-11
In Commercial Distribution

  • 00840916124687 ()


  • Metallic spinal interbody fusion cage
GE OMEGA III TABLE PAD 1 1/2" LAMIFOAM
AADCO MEDICAL, INC.
TP-982L
In Commercial Distribution

  • 00840348513066 ()
TP-982L

  • Freestanding patient positioner, reusable
GE OMEGA III TABLE PAD 1" SUPER SUPPORT FOAM
AADCO MEDICAL, INC.
TP-982C
In Commercial Distribution

  • 00840348513059 ()
TP-982C

  • Freestanding patient positioner, reusable
G.E. OMEGA V TABLE PAD 1" SUPER SUPPORT COATED
AADCO MEDICAL, INC.
TP-980C
In Commercial Distribution

  • 00840348512991 ()
TP-980C

  • Freestanding patient positioner, reusable
313/A2-010 Head End Shield - Panneau Tablle Omega 5
KENEX (ELECTRO-MEDICAL) LIMITED
313/A2-010
In Commercial Distribution

  • 05055449407175 ()
313/A2-010

  • Radiation shielding curtain
577nm Heine Omega 500 Indirect Ophthalmoscope with integrated adaptor
QUANTEL MEDICAL
IOH577
In Commercial Distribution

  • 03700542625392 ()


  • Indirect binocular laser ophthalmoscope
SENOMARK® Breast Tissue Marker, 12 Ga EnCor, SS "Omega"
SENORX, INC.
SMEC12GSS
In Commercial Distribution

  • 10801741031929 ()
  • 00801741031922 ()

  • Needle Gauge: 12 Gauge
SMEC12GSS

  • Radiological image marker, implantable
GEL MARK ULTRACOR Breast Tissue Marker, 14 Gauge, SS "Omega"
SENORX, INC.
GMUTC005SS
In Commercial Distribution

  • 10801741031899 ()
  • 00801741031892 ()

  • Needle Gauge: 14 Gauge
  • Needle Length, 10 Centimeter
GMUTC005SS

  • Radiological image marker, implantable
STARCHMARK® Breast Tissue Marker, 11 Ga Mammotome, SS "Omega"
SENORX, INC.
STMKMT11GSS
Not in Commercial Distribution

  • 10801741032186 ()
  • 00801741032189 ()

  • Needle Gauge: 11 Gauge
STMKMT11GSS

  • Radiological image marker, implantable
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