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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SENTINEL 11 / PATHFINDER SL KIT PL
SPACELABS HEALTHCARE (WASHINGTON), INC
98000; 98200
In Commercial Distribution

  • 10841522125867 ()
040-1752-01

  • Cardiology information system application software
  • Electrocardiographic long-term ambulatory recording analyser
SENTINEL 11 / PATHFINDER SL KIT SV
SPACELABS HEALTHCARE (WASHINGTON), INC
98000; 98200
In Commercial Distribution

  • 10841522125850 ()
040-1751-01

  • Cardiology information system application software
  • Electrocardiographic long-term ambulatory recording analyser
SENTINEL 11 / PATHFINDER SL KIT ES
SPACELABS HEALTHCARE (WASHINGTON), INC
98000; 98200
In Commercial Distribution

  • 10841522125843 ()
040-1750-01

  • Cardiology information system application software
  • Electrocardiographic long-term ambulatory recording analyser
SENTINEL 11 / PATHFINDER SL KIT IT  
SPACELABS HEALTHCARE (WASHINGTON), INC
98000; 98200
In Commercial Distribution

  • 10841522125836 ()
040-1749-01

  • Electrocardiographic long-term ambulatory recording analyser
  • Cardiology information system application software
SENTINEL 11 / PATHFINDER SL KIT FR
SPACELABS HEALTHCARE (WASHINGTON), INC
98000; 98200
In Commercial Distribution

  • 10841522125829 ()
040-1748-01

  • Electrocardiographic long-term ambulatory recording analyser
  • Cardiology information system application software
SENTINEL 11 / PATHFINDER SL KIT EN
SPACELABS HEALTHCARE (WASHINGTON), INC
98200; 98000
In Commercial Distribution

  • 10841522125768 ()
040-1708-01

  • Cardiology information system application software
  • Electrocardiographic long-term ambulatory recording analyser
Mead Mallet 11 1/2 oz,
Avalign Technologies, Inc.
VM104-1318
In Commercial Distribution

  • 00190776223670 ()


  • Surgical mallet
Sage tonsil snare, 11'', improved pattern
AMBLER SURGICAL CORP.
Sage tonsil snare
In Commercial Distribution

  • 00190660173869 ()
84-700

  • Nasal snare, reusable
6.75 X 11 LOCAL SPECIMEN BAG
Asp Global, LLC
504675BC
In Commercial Distribution

  • 00840216119888 ()


  • General specimen receptacle transport container
Vascular/Thoracic suction tube, 11", angled
AMBLER SURGICAL CORP.
89-839
In Commercial Distribution

  • 00190660186661 ()
89-839

  • Surgical/emergency suction cannula, non-illuminating, reusable
Black Pituitary Rongeur 4mm Straight 11"
Ebner Medical, LLC
52-116-40B
In Commercial Distribution

  • 00840217904650 ()

  • Length: 11 Inch
  • Width: 4 Millimeter
52-116-40B

  • Craniofacial rongeur, reusable
Black Pituitary Rongeur 3mm Straight 11"
Ebner Medical, LLC
52-116-30B
In Commercial Distribution

  • 00840217904643 ()

  • Length: 11 Inch
  • Width: 3 Millimeter
52-116-30B

  • Craniofacial rongeur, reusable
Black Pituitary Rongeur 2mm Straight 11"
Ebner Medical, LLC
52-116-20B
In Commercial Distribution

  • 00840217904636 ()

  • Length: 11 Inch
  • Width: 2 Millimeter
52-116-20B

  • Craniofacial rongeur, reusable
Vascular/Thoracic suction tube, 11'', angled
AMBLER SURGICAL CORP.
Vascular/Thoracic suction tube
In Commercial Distribution

  • 00190660186654 ()
89-838

  • Surgical/emergency suction cannula, non-illuminating, reusable
Size: Extra-Long 11 mm; Type: Radiopaque
Boston Medical Products, Inc.
62011R
In Commercial Distribution

  • EBES62011R0 ()
  • EBES62011R1 ()

  • Length (Outer Limb): 52 mm
  • Outer Diameter (Outer Limb): 11 mm
  • Length (Lower Inner Limb): 76 mm
  • Length (Upper Inner Limb): 76 mm
  • Length (Inner Limb): 162 mm
  • Outer Diameter (Inner Limb): 11 mm
62011R

  • Trachea prosthesis
Size: Extra-Long 11 mm; Type: Clear
Boston Medical Products, Inc.
620011
In Commercial Distribution

  • EBES6200110 ()
  • EBES6200111 ()

  • Length (Outer Limb): 52 mm
  • Outer Diameter (Outer Limb): 11 mm
  • Length (Lower Inner Limb): 76 mm
  • Length (Upper Inner Limb): 76 mm
  • Length (Inner Limb): 162 mm
  • Outer Diameter (Inner Limb): 11 mm
620011

  • Trachea prosthesis
Size: Thoracic 11 mm; Type: Radiopaque
Boston Medical Products, Inc.
52011R
In Commercial Distribution

  • EBES52011R0 ()
  • EBES52011R1 ()

  • Length (Outer Limb): 50 mm
  • Outer Diameter (Outer Limb): 11 mm
  • Length (Lower Inner Limb): 74 mm
  • Length (Upper Inner Limb): 30 mm
  • Length (Inner Limb): 115 mm
  • Outer Diameter (Inner Limb): 11 mm
52011R

  • Trachea prosthesis
Size: Thoracic 11 mm; Type: Clear
Boston Medical Products, Inc.
520011
In Commercial Distribution

  • EBES5200110 ()
  • EBES5200111 ()

  • Length (Outer Limb): 50 mm
  • Outer Diameter (Outer Limb): 11 mm
  • Length (Lower Inner Limb): 74 mm
  • Length (Upper Inner Limb): 30 mm
  • Length (Inner Limb): 115 mm
  • Outer Diameter (Inner Limb): 11 mm
520011

  • Trachea prosthesis
Offset Punch (1-1/4" Offset) Large
INNOMED, INC.
5125-02
In Commercial Distribution

  • 00840277108913 ()
5125-02

  • Bone-coring punch, reusable
St. Mark’s Retractor 11" with Lip
Automated Medical Products Corp.
St. Mark’s Retractor 11" with Lip
In Commercial Distribution

  • 00810118342462 ()
1620 11 SS

  • Surgical retractor/retraction system blade, reusable
Roger 11 (02) (blue lagoon trans.)
Phonak AG
052-3183-D02Q69
In Commercial Distribution

  • 07612904366392 ()
052-3183-D02Q69

  • Hearing aid enhanced audio device, teaching-environment
Roger 11 (02) (royal purple trans)
Phonak AG
052-3183-D02Q7
In Commercial Distribution

  • 07612904313341 ()
052-3183-D02Q7

  • Hearing aid enhanced audio device, teaching-environment
Roger 11 Tamper Proof (02) (petrol)
Phonak AG
052-3183-D02Q16
In Commercial Distribution

  • 07612904307333 ()
052-3183-D02Q16

  • Hearing aid enhanced audio device, teaching-environment
Roger 11 Tamper Proof (02) (champagne)
Phonak AG
052-3183-D02P56
In Commercial Distribution

  • 07612904307289 ()
052-3183-D02P56

  • Hearing aid enhanced audio device, teaching-environment
Roger 11 Tamper Proof (02) (chestnut)
Phonak AG
052-3183-D02P46
In Commercial Distribution

  • 07612904307272 ()
052-3183-D02P46

  • Hearing aid enhanced audio device, teaching-environment
Roger 11 Tamper Proof (02) (taupe)
Phonak AG
052-3183-D02356
In Commercial Distribution

  • 07612904307227 ()
052-3183-D02356

  • Hearing aid enhanced audio device, teaching-environment
Roger 11 Tamper Proof (02) (gray)
Phonak AG
052-3183-D02236
In Commercial Distribution

  • 07612904307197 ()
052-3183-D02236

  • Hearing aid enhanced audio device, teaching-environment
Easy Clean Wheelchair Arm Rest (11")
VIVE HEALTH LLC
CSH1096BLK11
In Commercial Distribution

  • 10810113574735 ()
  • 00810113574738 ()


  • Chair/stool armrest
1-1, 17mm plate, extended, 12mm spacer
CAMBER SPINE TECHNOLOGIES, LLC
FCP-212E
Not in Commercial Distribution

  • B030FCP212E0 ()


  • Spinal fixation plate, non-bioabsorbable
1-1, 17mm plate, standard, 12mm spacer
CAMBER SPINE TECHNOLOGIES, LLC
FCP-212
In Commercial Distribution

  • B030FCP2120 ()

  • Length: 17 Millimeter
  • Width: 16 Millimeter
  • Depth: 2 Millimeter


  • Spinal fixation plate, non-bioabsorbable
1-1, 16mm plate, extended, 11mm spacer
CAMBER SPINE TECHNOLOGIES, LLC
FCP-211E
Not in Commercial Distribution

  • B030FCP211E0 ()


  • Spinal fixation plate, non-bioabsorbable
1-1, 16mm plate, standard, 11mm spacer
CAMBER SPINE TECHNOLOGIES, LLC
FCP-211
In Commercial Distribution

  • B030FCP2110 ()

  • Length: 16 Millimeter
  • Width: 16 Millimeter
  • Depth: 2 Millimeter


  • Spinal fixation plate, non-bioabsorbable
1-1, 15mm plate, extended, 10mm spacer
CAMBER SPINE TECHNOLOGIES, LLC
FCP-210E
Not in Commercial Distribution

  • B030FCP210E0 ()


  • Spinal fixation plate, non-bioabsorbable
1-1, 14mm plate, extended, 9mm spacer
CAMBER SPINE TECHNOLOGIES, LLC
FCP-209E
Not in Commercial Distribution

  • B030FCP209E0 ()


  • Spinal fixation plate, non-bioabsorbable
1-1, 13mm plate, extended, 8mm spacer
CAMBER SPINE TECHNOLOGIES, LLC
FCP-208E
Not in Commercial Distribution

  • B030FCP208E0 ()


  • Spinal fixation plate, non-bioabsorbable
1-1, 12mm plate, extended, 7mm spacer
CAMBER SPINE TECHNOLOGIES, LLC
FCP-207E
Not in Commercial Distribution

  • B030FCP207E0 ()


  • Spinal fixation plate, non-bioabsorbable
1-1, 11mm plate, extended, 6mm spacer
CAMBER SPINE TECHNOLOGIES, LLC
FCP-206E
Not in Commercial Distribution

  • B030FCP206E0 ()


  • Spinal fixation plate, non-bioabsorbable
1-1, 10mm plate, standard, 5mm spacer
CAMBER SPINE TECHNOLOGIES, LLC
FCP-205
In Commercial Distribution

  • B030FCP2050 ()

  • Length: 10 Millimeter
  • Width: 16 Millimeter
  • Depth: 2 Millimeter


  • Spinal fixation plate, non-bioabsorbable
11 Panel Cup Drug Test, AMP-BAR-BZO-COC-MET500-MTD-OPI-OXY-PCP-TCA-THC
CLINICAL REFERENCE LABORATORY, INC.
51100
Not in Commercial Distribution

  • 81781502511007 ()
51100

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Roger 11 (02) (royal purple trans)
Phonak AG
052-3183-D02Q79
In Commercial Distribution

  • 07612904366408 ()
052-3183-D02Q79

  • Hearing aid enhanced audio device, teaching-environment
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