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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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Resmed Airsense 11 CPAP Filter
SUNSET HEALTHCARE SOLUTIONS, INC.
39300
In Commercial Distribution

  • 00848530098438 ()


  • CPAP/BPAP unit ambient air filter, reusable
Resmed Airsense 11 CPAP Filter
SUNSET HEALTHCARE SOLUTIONS, INC.
CF2111-2
In Commercial Distribution

  • 00848530096465 ()


  • CPAP/BPAP unit ambient air filter, single-use
Disc Scraper, Size 11 mm
K2M, INC.
3201-90144
In Commercial Distribution

  • 10888857057999 ()

  • Height: 11 Millimeter
3201-90144

  • Orthopaedic prosthesis implantation positioning instrument, reusable
DLZ-4.2-100 11/0 pa 15cm
Surgical Specialties México, S. de R.L. de C.V.
A007PA
In Commercial Distribution

  • 10848782032522 ()
  • 00848782032525 ()

  • 15 cm


  • Nylon suture, non-bioabsorbable, monofilament
UTS Broach, ML 0mm, #11
UNITED ORTHOPEDIC CORP.
9116-6011
In Commercial Distribution

  • 04711605582155 ()

  • ML 0mm, #11
9116-6011

  • Orthopaedic broach
11 Hole Extended Y Plate
OSTEOMED LLC
213-0017
In Commercial Distribution

  • 00845694003018 ()

  • Length: 33 Millimeter
213-0017

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
RESCUE CERVICAL SCREW 11 MM
PARAMOUNT SURGICALS, INC.
320-4511
In Commercial Distribution

  • 00852647007696 ()

  • Height: 11 Millimeter
320-4511

  • Spinal fixation plate, non-bioabsorbable
11 Volt Li-Ion Backup Battery
Thoratec Corporation
106128
In Commercial Distribution

106128

  • Secondary battery
PERIOSTEAL ELEVATORS SET (11 PCS)
Power Dental U.S.A. Inc.
9008-BIBT
In Commercial Distribution

  • D9439008BIBT00 ()
9008-BIBT

  • Dental elevator, tooth/root
  • Periosteal elevator, reusable
Sublime Arís Cover Size 11
TRULIFE LIMITED
C15111
In Commercial Distribution

  • 00643293026502 ()


  • External breast prosthesis
Impressions II Cover Size 11
TRULIFE LIMITED
C10111
In Commercial Distribution

  • 00643293025277 ()


  • External breast prosthesis
Silk Xtend Right Size 11
TRULIFE LIMITED
478R11
In Commercial Distribution

  • 00643293016886 ()


  • External breast prosthesis
Classic Cover Left Size 11
TRULIFE LIMITED
C399L11
In Commercial Distribution

  • 00643293010730 ()


  • External breast prosthesis
Silk Xtend Left Size 11
TRULIFE LIMITED
478L11
In Commercial Distribution

  • 00643293016749 ()


  • External breast prosthesis
Classic Cover Right Size 11
TRULIFE LIMITED
C399R11
In Commercial Distribution

  • 00643293010747 ()


  • External breast prosthesis
WAUPS- SURGERY KIT (11 PCS)
Power Dental U.S.A. Inc.
9040
In Commercial Distribution

  • D94390400 ()
9040

  • Dental surgical probe, reusable
  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
A Supreme Right Size 11
TRULIFE LIMITED
503 11R
In Commercial Distribution

  • 00643293000229 ()


  • External breast prosthesis
A Supreme Left Size 11
TRULIFE LIMITED
503 11L
In Commercial Distribution

  • 00643293000212 ()


  • External breast prosthesis
Large Maxillary Expansion 11 mm
ORTHOSOURCE
5005/15
In Commercial Distribution

  • D9115005150 ()


  • Orthodontic palate expander/teeth aligner, self-removable
ENDO PLUGGERS/CONDENSERS RCP9/11
Power Dental U.S.A. Inc.
3309
In Commercial Distribution

  • D9433309 ()
3309

  • Dental amalgam carrier
  • Dental spatula, reusable
  • Endodontic plugger
EXPLORERS EXD 11/12AF 6EZ
Power Dental U.S.A. Inc.
1019E
In Commercial Distribution

  • D9431019E00 ()
1019E

  • Dental surgical probe, reusable
EXPLORERS EXD 11/12AF 3EZ
Power Dental U.S.A. Inc.
1019
In Commercial Distribution

  • D94310190 ()
1019

  • Dental surgical probe, reusable
#11/12 Back-Action DE Plugger
HU-FRIEDY MFG. CO., LLC
PLG11/12
In Commercial Distribution

  • 10889950019228 ()
PLG11/12

  • Endodontic plugger
#11 Novatech Cement Placement Inst.
HU-FRIEDY MFG. CO., LLC
PINT11
In Commercial Distribution

  • 10889950018887 ()
PINT11

  • Dental material application tool, reusable
#11/12 Buck DE File
HU-FRIEDY MFG. CO., LLC
FB11/12
In Commercial Distribution

  • 10889950012298 ()


  • Periodontal file/rasp, manual
11/12 Buck DE File
HU-FRIEDY MFG. CO., LLC
FB11/126
In Commercial Distribution

  • 10889950012304 ()


  • Periodontal file/rasp, manual
#11/12 ODU DE Explorer
HU-FRIEDY MFG. CO., LLC
EXD11/12
In Commercial Distribution

  • 10889950010805 ()
EXD11/12

  • Dental surgical probe, reusable
#11/12 McCall DE Scaler
HU-FRIEDY MFG. CO., LLC
SM11/12
In Commercial Distribution

  • 10889950029845 ()


  • Manual dental scaler, reusable
#11/14 Gracey DE Curette
HU-FRIEDY MFG. CO., LLC
SG11/14
In Commercial Distribution

  • 10889950025960 ()


  • Periodontal curette
#11/12 Gracey DE Curette
HU-FRIEDY MFG. CO., LLC
SG11/12
In Commercial Distribution

  • 10889950025762 ()


  • Periodontal curette
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