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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No Description
BIOMET SPINE LLC
55001911
In Commercial Distribution

  • 00880304908246 ()

  • Lordotic 11 x 11 x 11 mm PEEK Spacer with X-Ray Markers
55001911

  • Vertebral body prosthesis
Self-Sealing sterilization pouches with internal and external indicators. 200 per box
PRACTICON, INC.
7158235
In Commercial Distribution

  • 00723896026434 ()
  • 00723896026427 ()
7158235

  • Sterilization packaging, single-use
Clean-Bor Tube
Vacumed
1010-14
In Commercial Distribution

  • 00850644007473 ()
1010-14

  • Gas-sampling/monitoring respiratory tubing, single-use
Clean-Bor Tube
Vacumed
1012-36
In Commercial Distribution

  • 00850644007831 ()
1012-36

  • Gas-sampling/monitoring respiratory tubing, single-use
Clean-Bor Tube
Vacumed
1012-13-BULK
In Commercial Distribution

  • 00850644007824 ()
  • 08506440078248 ()
1012-13-BULK

  • Gas-sampling/monitoring respiratory tubing, single-use
Clean-Bor Tube
Vacumed
1012-13
In Commercial Distribution

  • 00850644007817 ()
1012-13

  • Gas-sampling/monitoring respiratory tubing, single-use
Clean-Bor Tube
Vacumed
1010-60
In Commercial Distribution

  • 00850644007510 ()
1010-60

  • Gas-sampling/monitoring respiratory tubing, single-use
Clean-Bor Tube
Vacumed
1010-36-BULK
In Commercial Distribution

  • 00850644007503 ()
  • 08506440075032 ()
1010-36-BULK

  • Gas-sampling/monitoring respiratory tubing, single-use
Clean-Bor Tube
Vacumed
1010-36
In Commercial Distribution

  • 00850644007497 ()
1010-36

  • Gas-sampling/monitoring respiratory tubing, single-use
Clean-Bor Tube
Vacumed
1010-14-BULK
In Commercial Distribution

  • 00850644007480 ()
  • 08506440074806 ()
1010-14-BULK

  • Gas-sampling/monitoring respiratory tubing, single-use
No Description
Lina Medical ApS
MT-EP-11
In Commercial Distribution

  • 05708265004997 ()
MT-EP-11

  • Earplugs, single-use
ELEVATE™ ENT Instrumentation Set of 11 Elevate ENT Handpieces and 1 tray
OMNIGUIDE, INC.
321016
In Commercial Distribution

  • 00852306007296 ()
321016

  • Urogenital surgical laser system beam guide, reusable
These accessory immobilization devices are intended for use in conjunction with a NeoCoil Flex Coil for patient comfort and stabilization. Please refer to the device labeling for intended use of your particular NeoCoil Flex Coil.
NEOCOIL, LLC
53
In Commercial Distribution

  • 00856181003534 ()


  • MRI system coil, radio-frequency
These accessory immobilization devices are intended for use in conjunction with a NeoCoil Flex Coil for patient comfort and stabilization. Please refer to the device labeling for intended use of your particular NeoCoil Flex Coil.
NEOCOIL, LLC
46
In Commercial Distribution

  • 00856181003466 ()


  • MRI system coil, radio-frequency
Smartphone case with magnetic connection for compatible DL models
DermLite LLC
DLCKi11
In Commercial Distribution

  • 00855997006739 ()
DLCKi11

  • Dermatoscope, optical
Rabbit antiserum, Ready to use
Ssi Diagnostica A/S
16905
In Commercial Distribution

  • 05713106169056 ()
16905

  • Streptococcus pneumoniae culture isolate antigen IVD, antibody
No Description
Bird & Cronin, LLC
08145425
In Commercial Distribution

  • 00610570017614 ()


  • Wrist immobilizer, single-use
No Description
Bird & Cronin, LLC
08145424
In Commercial Distribution

  • 00610570017607 ()


  • Wrist immobilizer, single-use
No Description
Bird & Cronin, LLC
08145423
In Commercial Distribution

  • 00610570017591 ()


  • Wrist immobilizer, single-use
No Description
Bird & Cronin, LLC
08145422
In Commercial Distribution

  • 00610570017584 ()


  • Wrist immobilizer, single-use
No Description
Bird & Cronin, LLC
08145421
In Commercial Distribution

  • 00610570017577 ()


  • Wrist immobilizer, single-use
No Description
Bird & Cronin, LLC
08145420
In Commercial Distribution

  • 00610570017560 ()


  • Wrist immobilizer, single-use
No Description
Bird & Cronin, LLC
08145415
In Commercial Distribution

  • 00610570017553 ()


  • Wrist immobilizer, single-use
No Description
Bird & Cronin, LLC
08145414
In Commercial Distribution

  • 00610570017546 ()


  • Wrist immobilizer, single-use
No Description
Bird & Cronin, LLC
08145413
In Commercial Distribution

  • 00610570017539 ()


  • Wrist immobilizer, single-use
No Description
Bird & Cronin, LLC
08145412
Not in Commercial Distribution

  • 00610570017522 ()


  • Wrist immobilizer, single-use
No Description
Bird & Cronin, LLC
08145411
In Commercial Distribution

  • 00610570017515 ()


  • Wrist immobilizer, single-use
No Description
Bird & Cronin, LLC
08145410
In Commercial Distribution

  • 00610570017508 ()


  • Wrist immobilizer, single-use
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-20-6911
In Commercial Distribution

  • 09348215073459 ()


  • Orthopaedic broach
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
3012-011
In Commercial Distribution

  • 00848665006377 ()


  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
ResMed S11HA: 20 hypoallergenic filters
SUNSET HEALTHCARE SOLUTIONS, INC.
AUSE001S11HA-20
In Commercial Distribution

  • 10848530102002 ()
  • 00848530102005 ()


  • CPAP/BPAP unit ambient air filter, single-use
ResMed S11: 52 disposable filters
SUNSET HEALTHCARE SOLUTIONS, INC.
AUSE001S11-52
In Commercial Distribution

  • 10848530101999 ()
  • 00848530101992 ()


  • CPAP/BPAP unit ambient air filter, single-use
No Description
KATALYST SURGICAL LLC
N077-080
In Commercial Distribution

  • 00840096203875 ()


  • Periosteal elevator, reusable
Intended for tissue separation, and other procedures that require a sharp surgical blade to puncture or cut.
ASPEN SURGICAL PRODUCTS, INC.
373911
In Commercial Distribution

  • 00840113203079 ()
  • 00840113203093 ()
  • 00840113203086 ()


  • Manual scalpel blade, single-use
No Description
FOURNITURES HOSPITALIERES INDUSTRIE
239564
In Commercial Distribution

  • 03661489395642 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
FOURNITURES HOSPITALIERES INDUSTRIE
201774
In Commercial Distribution

  • 03661489017742 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
Hausmann Enterprises, LLC
1582
In Commercial Distribution

  • 00840314803986 ()


  • Stair-climbing exerciser, non-powered
No Description
Hausmann Enterprises, LLC
1580
In Commercial Distribution

  • 00840314803979 ()


  • Stair-climbing exerciser, non-powered
EXEL SRGCL BLADE,C-S, SIZE:11; 100/BX, 1000/CS, 10CS/CRTN
Exel International
29526
In Commercial Distribution

  • 10020221295266 ()
  • 00020221295269 ()
  • 20020221295263 ()
  • 30020221295260 ()
29526

  • Manual scalpel blade, single-use
EXEL SRGCL BLADE,S-S, SIZE:11; 100/BX, 1000/CS, 10CS/CRTN
Exel International
29502
In Commercial Distribution

  • 10020221295020 ()
  • 00020221295023 ()
  • 20020221295027 ()
  • 30020221295024 ()
29502

  • Manual scalpel blade, single-use
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