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® EXPANSION DRIVER
SPINAL ELEMENTS, INC.
11418-095
In Commercial Distribution

  • 00840606163262 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
OMEGA XP® INSERTER - SHORT
SPINAL ELEMENTS, INC.
11401-165
In Commercial Distribution

  • 00840606163217 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
OMEGA XP® INSERTER - SHORT
SPINAL ELEMENTS, INC.
11401-065
In Commercial Distribution

  • 00840606163194 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
OMEGA LOOP FORM.PLIERS CLASSIX TWEED
LEONE SPA
P2102-00
In Commercial Distribution

  • 08033707080800 ()
P2102-00

  • Orthodontic pliers
STRL OMEGA QUICK KIT PK
Cardinal Health 200, LLC
SBA43QKOIA
In Commercial Distribution

  • 50885425374463 ()
  • 10885425374465 ()
SBA43QKOIA

  • General surgical procedure kit, non-medicated, single-use
Soft-Vu Angiographic Catheter, Omega, Braided
ANGIODYNAMICS, INC.
10710092
In Commercial Distribution

  • 15051684016094 ()
  • H787107100920 ()
  • H787107100925 ()

  • Catheter Gauge: 5 French
  • Outer Diameter: 1.8 Millimeter
  • Length: 130 Centimeter


  • Angiographic catheter, single-use
Soft-Vu Angiographic Catheter, Omega, Non-Braided
ANGIODYNAMICS, INC.
10710091
In Commercial Distribution

  • 15051684016087 ()
  • H787107100910 ()
  • H787107100915 ()

  • Catheter Gauge: 5 French
  • Outer Diameter: 1.8 Millimeter
  • Length: 100 Centimeter


  • Angiographic catheter, single-use
Soft-Vu Angiographic Catheter, Omega, Braided
ANGIODYNAMICS, INC.
10710090
In Commercial Distribution

  • 15051684016070 ()
  • H787107100900 ()
  • H787107100905 ()

  • Catheter Gauge: 5 French
  • Length: 100 Centimeter
  • Outer Diameter: 1.8 Millimeter


  • Angiographic catheter, single-use
Mariner Angiographic Catheter, Omega, Braided
ANGIODYNAMICS, INC.
11710514
In Commercial Distribution

  • 15051684016384 ()
  • H787117105140 ()
  • H787117105145 ()

  • Length: 130 Centimeter
  • Catheter Gauge: 5 French
  • Outer Diameter: 1.8 Millimeter


  • Angiographic catheter, single-use
Mariner Angiographic Catheter, Omega, Non-Braided
ANGIODYNAMICS, INC.
11710513
Not in Commercial Distribution

  • 15051684016377 ()
  • H787117105130 ()
  • H787117105135 ()

  • Catheter Gauge: 5 French
  • Outer Diameter: 1.8 Millimeter
  • Length: 100 Centimeter


  • Angiographic catheter, single-use
Mariner Angiographic Catheter, Omega, Braided
ANGIODYNAMICS, INC.
11710512
In Commercial Distribution

  • 15051684016360 ()
  • H787117105120 ()
  • H787117105125 ()

  • Outer Diameter: 1.8 Millimeter
  • Length: 100 Centimeter
  • Catheter Gauge: 5 French


  • Angiographic catheter, single-use
Mariner Angiographic Catheter, Omega, Braided
ANGIODYNAMICS, INC.
11710507
In Commercial Distribution

  • 15051684016315 ()
  • H787117105070 ()
  • H787117105075 ()

  • Outer Diameter: 1.8 Millimeter
  • Catheter Gauge: 5 French
  • Length: 65 Centimeter


  • Angiographic catheter, single-use
Facebow Long #5 111mm Omega
ORTHOQUEST, INC.
L0234
In Commercial Distribution

  • 10817713022604 ()


  • Orthodontic extraoral headgear
Facebow Long #4 104mm Omega
ORTHOQUEST, INC.
L0233
In Commercial Distribution

  • 10817713022598 ()


  • Orthodontic extraoral headgear
Facebow Long #3 97mm Omega
ORTHOQUEST, INC.
L0232
In Commercial Distribution

  • 10817713022567 ()


  • Orthodontic extraoral headgear
Facebow Long #2 90mm Omega
ORTHOQUEST, INC.
L0231
In Commercial Distribution

  • 10817713022550 ()


  • Orthodontic extraoral headgear
Facebow Long #1 83mm Omega
ORTHOQUEST, INC.
L0230
In Commercial Distribution

  • 10817713022543 ()


  • Orthodontic extraoral headgear
Facebow Short #4 104mm Omega
ORTHOQUEST, INC.
L0219
In Commercial Distribution

  • 10817713022529 ()


  • Orthodontic extraoral headgear
Facebow Short #3 97mm Omega
ORTHOQUEST, INC.
L0218
In Commercial Distribution

  • 10817713022512 ()


  • Orthodontic extraoral headgear
Facebow Short #2 90mm Omega
ORTHOQUEST, INC.
L0217
In Commercial Distribution

  • 10817713022505 ()


  • Orthodontic extraoral headgear
Facebow Short #1 83mm Omega
ORTHOQUEST, INC.
L0216
In Commercial Distribution

  • 10817713022499 ()


  • Orthodontic extraoral headgear
Facebow Short #5 111mm Omega
ORTHOQUEST, INC.
L0214
In Commercial Distribution

  • 10817713022475 ()


  • Orthodontic extraoral headgear
GE OMEGA III 2" LO-SORB
AADCO MEDICAL, INC.
TP-982
In Commercial Distribution

  • 00840348513042 ()
TP-982

  • Freestanding patient positioner, reusable
Omega loop formaing plier, tweed style
POMEE CORPORATION
7106
In Commercial Distribution

  • G15771060 ()
7106

  • Orthodontic pliers
3.9MM OMEGA AND 4.75MM ALPHAVENT AWL
STRYKER CORPORATION
3910947200
In Commercial Distribution

  • 07613327550009 ()
3910-947-200

  • Bone awl, reusable
TRAY CUSTOM F/ OMEGA PAIN CUSTOM
HENRY SCHEIN, INC.
5703064
In Commercial Distribution

  • 00304040167717 ()
  • 10304040167714 ()
5703064

  • General surgical procedure kit, non-medicated, single-use
PACK REFILL F/ OMEGA PAIN CUSTOM
HENRY SCHEIN, INC.
5703063
In Commercial Distribution

  • 00304040166758 ()
  • 10304040166755 ()
5703063

  • General surgical procedure kit, non-medicated, single-use
MySpine Ø2 Omega drill, AO conn
Medacta International SA
03.51.10.0798
In Commercial Distribution

  • 07630345779779 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
OMEGA XP® AXIAL BREAKDOWN KNOB
SPINAL ELEMENTS, INC.
SP-0518-15
In Commercial Distribution

  • 00840916148560 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
OMEGA XP® AXIAL INSERTER - SHORT
SPINAL ELEMENTS, INC.
11419-065
In Commercial Distribution

  • 00840606163576 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
OMEGA XP® EXPANSION DRIVER - SHORT
SPINAL ELEMENTS, INC.
11418-065
In Commercial Distribution

  • 00840606163279 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
OMEGA XP® AXIAL EXPANSION DRIVER
SPINAL ELEMENTS, INC.
11418-295
In Commercial Distribution

  • 00840606163286 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
OMEGA XP® INSERTER INNER SHAFT
SPINAL ELEMENTS, INC.
11402-095
In Commercial Distribution

  • 00840606163224 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
OMEGA SCREWDRIVER HANDLE MINIATURE ROUND SIZE
SONTEC INSTRUMENTS, INC.
1106-287
In Commercial Distribution

  • 00192896054110 ()
1106-287

  • Surgical screwdriver, reusable
Tray Custom F/ Omega Pain Clinic
HENRY SCHEIN, INC.
5703063
In Commercial Distribution

  • H65857030631 ()
  • H65857030635 ()
5703063

  • General surgical procedure kit, medicated
Pack Refill F/ Omega Pain Clinic
HENRY SCHEIN, INC.
5703062
In Commercial Distribution

  • H65857030621 ()
  • H65857030625 ()
5703062

  • General surgical procedure kit, medicated
OMEGA QUICK KIT PK, F G
Cardinal Health 200, LLC
SBA43QKOIB
In Commercial Distribution

  • 50197106292912 ()
  • 10197106292914 ()
SBA43QKOIB

  • General surgical procedure kit, non-medicated, single-use
Oval Universal Disc w/ Omega opening
Tz Medical, Inc.
8880-03
In Commercial Distribution

  • 00811331013252 ()
  • 10811331013259 ()


  • Femoral artery compression system, manual, single-use
Round Universal Disc w/ Omega opening
Tz Medical, Inc.
8880-04
In Commercial Distribution

  • 00811331010480 ()
  • 10811331010487 ()


  • Femoral artery compression system, manual, single-use
G.E. OMEGA TABLE PAD LAMI FOAM
AADCO MEDICAL, INC.
TP-916L
In Commercial Distribution

  • 00840348511277 ()
TP-916L

  • Freestanding patient positioner, reusable
G.E. OMEGA TABLE PAD CONTOUR FOAM
AADCO MEDICAL, INC.
TP-916
In Commercial Distribution

  • 00840348511253 ()
TP-916

  • Freestanding patient positioner, reusable
OMEGA QUICK KIT PK,STRL F/G
Cardinal Health 200, LLC
SBA43QKOI1
In Commercial Distribution

  • 50888439698624 ()
  • 10888439698626 ()
SBA43QKOI1

  • General surgical procedure kit, non-medicated, single-use
Orthorama® sectional arches without Omega loop
DENTAURUM GmbH & Co.KG
728-217-00
In Commercial Distribution

  • J011728217000 ()
  • J011728217001 ()


  • Orthodontic archwire
Orthorama® sectional arches with Omega loop
DENTAURUM GmbH & Co.KG
728-216-00
In Commercial Distribution

  • J011728216000 ()
  • J011728216001 ()


  • Orthodontic archwire
Omega Drill Ø2.7mm STD-conn Removable locking handle
Medacta International SA
03.51.10.0792
In Commercial Distribution

  • 07630971289826 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Omega Drill Ø2.7mm AO-conn Removable locking handle
Medacta International SA
03.51.10.0790
In Commercial Distribution

  • 07630971289802 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Large Round Universal Disc w/ Omega opening
Tz Medical, Inc.
8880-06
In Commercial Distribution

  • 00811331011838 ()
  • 00811331011845 ()


  • Femoral artery compression system, manual, single-use
MySpine Ø2 Omega drill, AO conn - 10mm
Medacta International SA
03.51.10.0746
In Commercial Distribution

  • 07630542726217 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
MySpine Ø2 Omega drill, AO conn - 15mm
Medacta International SA
03.51.10.0745
In Commercial Distribution

  • 07630542726200 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
MySpine Ø2 Omega drill, AO conn - 20mm
Medacta International SA
03.51.10.0744
In Commercial Distribution

  • 07630542726194 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
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