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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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Ruggedized Patient Breathing Circuit, case of 10
Safeguard US Operating, LLC
02
In Commercial Distribution

  • M689M4010510020 ()
M40105-10

  • Ventilator breathing circuit, single-use
ACCU-CHEK AVIVA PLUS SAMPLE KIT 20/CASE
Roche Diagnostics Operations, Inc.
08350060001
Not in Commercial Distribution

  • 10365702724102 ()
  • 00365702724105 ()


  • Glucose IVD, kit, spectrophotometry
Accu-Chek Aviva Plus Retail Kit 10/case
Roche Diagnostics Operations, Inc.
08350051001
Not in Commercial Distribution

  • 00365702723108 ()
  • 10365702723105 ()


  • Glucose IVD, kit, spectrophotometry
ACCU-CHEK AVIVA CONNECT RETAIL KIT 8/CASE
Roche Diagnostics Operations, Inc.
07049706001
Not in Commercial Distribution

  • 10365702577104 ()
  • 00365702577107 ()
07049706001

  • Glucose IVD, kit, spectrophotometry
ACCU-CHEK AVIVA PLUS HNP KIT 8/CASE
Roche Diagnostics Operations, Inc.
07021941001
Not in Commercial Distribution

  • 00365702134102 ()
  • 10365702134109 ()
07021941001

  • Glucose IVD, kit, spectrophotometry
ACCU-CHEK AVIVA PLUS RETAIL KIT 8/CASE
Roche Diagnostics Operations, Inc.
06988580001
Not in Commercial Distribution

  • 00365702101104 ()
  • 10365702101101 ()
06988580001

  • Glucose IVD, kit, spectrophotometry
22 piece Prism Block Set, polymer case
Optego Vision USA Inc.
92352
In Commercial Distribution

  • 00360843010216 ()


  • Diagnostic ophthalmic prism
ACCU-CHEK AVIVA CONNECT SAMPLE KIT 16/CASE
Roche Diagnostics Operations, Inc.
07049692001
Not in Commercial Distribution

  • 10365702576107 ()
  • 00365702576100 ()
07049692001

  • Glucose IVD, kit, spectrophotometry
ACCU-CHEK NANO RETAIL KIT DSGNR 8/CASE
Roche Diagnostics Operations, Inc.
07008325001
Not in Commercial Distribution

  • 00365702567108 ()
  • 10365702567105 ()
07008325001

  • Glucose IVD, kit, spectrophotometry
ACCU-CHEK AVIVA PLUS SAMPLE KIT 16/CASE
Roche Diagnostics Operations, Inc.
06988563001
Not in Commercial Distribution

  • 00365702445109 ()
  • 10365702445106 ()
06988563001

  • Glucose IVD, kit, spectrophotometry
SideStream Custom Nebulizer Kit, Case of 25
RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD
00
In Commercial Distribution

  • 00383730001609 ()
1028125

  • Benchtop nebulizer, non-heated
Sterilization Case, Capless (or X90) System, Implant
Xtant Medical Holdings, Inc.
N60000275
In Commercial Distribution

  • M697N600002750 ()
  • M697N600002751 ()


  • Device sterilization/disinfection container, reusable
Sterilization Case, Capless (or X90) System, Instrument
Xtant Medical Holdings, Inc.
N60000274
In Commercial Distribution

  • M697N600002740 ()
  • M697N600002741 ()


  • Device sterilization/disinfection container, reusable
Specialty Silex 800 mm Steinmann pin case
Xtant Medical Holdings, Inc.
C079-0055
In Commercial Distribution

  • M697C07900550 ()
  • M697C07900551 ()

  • Length: 800 Millimeter


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit
BK S3, coated, wooden case with handle
OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
335011
In Commercial Distribution

  • 04049584001733 ()


  • Trial lens frame
BK S3, wooden lens case with handle
OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
33501
In Commercial Distribution

  • 04049584001726 ()


  • Trial lens frame
BK S2, coated, wooden case with handle
OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
334901
In Commercial Distribution

  • 04049584001627 ()


  • Trial lens frame
BK 2, coated, wooden case with handle
OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
334801
Not in Commercial Distribution

  • 04049584001498 ()


  • Trial lens frame
APEX Gen II Instrument Case 2, Deformity
SPINECRAFT, LLC
6000-200
In Commercial Distribution

  • 00193082155390 ()
6000-200

  • General internal orthopaedic fixation system implantation kit
APEX Gen II Instrument Case 1, Low-Back
SPINECRAFT, LLC
6000-100
In Commercial Distribution

  • 00193082155345 ()
6000-100

  • General internal orthopaedic fixation system implantation kit
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