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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Hallux Limitus Plate
Sky Surgical, LLC
P0002
In Commercial Distribution

  • 00850024702028 ()


  • Orthopaedic fixation plate, non-bioabsorbable
Medial Bunion Plate, Right
Sky Surgical, LLC
P0001R
In Commercial Distribution

  • 00850024702011 ()


  • Orthopaedic fixation plate, non-bioabsorbable
Medial Bunion Plate, Left
Sky Surgical, LLC
P0001L
In Commercial Distribution

  • 00850024702004 ()


  • Orthopaedic fixation plate, non-bioabsorbable
No Description
AMERICAN MEDICAL ENDOSCOPY, INC.
STS-LAP-125-53FC
In Commercial Distribution

  • 00850024135338 ()


  • Suturing needle holder, reusable
No Description
AMERICAN MEDICAL ENDOSCOPY, INC.
STS-LAP-125-53RTCA
In Commercial Distribution

  • 00850024135321 ()


  • Suturing needle holder, reusable
No Description
AMERICAN MEDICAL ENDOSCOPY, INC.
STS-LAP-125-53LTCC
In Commercial Distribution

  • 00850024135314 ()


  • Suturing needle holder, reusable
No Description
AMERICAN MEDICAL ENDOSCOPY, INC.
STS-LAP-125-53STCC
In Commercial Distribution

  • 00850024135307 ()


  • Suturing needle holder, reusable
No Description
AMERICAN MEDICAL ENDOSCOPY, INC.
STS-LAP-125-54FS
In Commercial Distribution

  • 00850024135291 ()


  • Suturing needle holder, reusable
No Description
AMERICAN MEDICAL ENDOSCOPY, INC.
STS-LAP-125-54LTCS
In Commercial Distribution

  • 00850024135284 ()


  • Suturing needle holder, reusable
No Description
AMERICAN MEDICAL ENDOSCOPY, INC.
STS-LAP-125-53LTCS
In Commercial Distribution

  • 00850024135277 ()


  • Suturing needle holder, reusable
No Description
AMERICAN MEDICAL ENDOSCOPY, INC.
STS-LAP-125-53STCS
In Commercial Distribution

  • 00850024135260 ()


  • Suturing needle holder, reusable
Single-Use Digital Flexible Cystoscope
Otu Medical Inc.
OTU-C311R
In Commercial Distribution

  • 10850023925432 ()
  • 00850023925435 ()
  • 20850023925439 ()


  • Flexible video cystoscope, single-use
Single-Use Digital Flexible Cystoscope
Otu Medical Inc.
OTU-C311S
In Commercial Distribution

  • 10850023925425 ()
  • 00850023925428 ()
  • 20850023925422 ()


  • Flexible video cystoscope, single-use
Aptra Single-Use Digital Flexible Cystoscope
Otu Medical Inc.
BDCYRD01
In Commercial Distribution

  • 10850023925395 ()
  • 00850023925398 ()
  • 20850023925392 ()


  • Flexible video cystoscope, single-use
Aptra Single-Use Digital Flexible Cystoscope
Otu Medical Inc.
BDCYSD01
In Commercial Distribution

  • 10850023925388 ()
  • 00850023925381 ()
  • 20850023925385 ()


  • Flexible video cystoscope, single-use
Single-Use Digital Flexible Ureteroscope
Otu Medical Inc.
OTU-120S
In Commercial Distribution

  • 10850023925333 ()
  • 00850023925336 ()
4101U0501T

  • Flexible video ureteroscope, single-use
Single-Use Digital Flexible Ureteroscope
Otu Medical Inc.
OTU-120R
In Commercial Distribution

  • 10850023925326 ()
  • 00850023925329 ()
4101U0601T

  • Flexible video ureteroscope, single-use
Single-Use Digital Flexible Ureteroscope/Choledochoscope
Otu Medical Inc.
OTU-OM100R
In Commercial Distribution

  • 10850023925302 ()
  • 00850023925305 ()


  • Flexible video ureteroscope, single-use
  • Flexible video choledochoscope, single-use
Single-Use Digital Flexible Ureteroscope/Choledochoscope
Otu Medical Inc.
OTU-OM100S
In Commercial Distribution

  • 10850023925296 ()
  • 00850023925299 ()


  • Flexible video choledochoscope, single-use
  • Flexible video ureteroscope, single-use
Single-Use Digital Flexible Ureteroscope/Choledochoscope
Otu Medical Inc.
OTU-OM100RL
In Commercial Distribution

  • 10850023925265 ()
  • 00850023925268 ()


  • Flexible video choledochoscope, single-use
  • Flexible video ureteroscope, single-use
Single-Use Digital Flexible Ureteroscope/Choledochoscope
Otu Medical Inc.
OTU-OM100SL
In Commercial Distribution

  • 10850023925258 ()
  • 00850023925251 ()


  • Flexible video choledochoscope, single-use
  • Flexible video ureteroscope, single-use
Single-Use Digital Flexible Ureteroscope/Choledochoscope
Otu Medical Inc.
OTU-OM100RR
In Commercial Distribution

  • 10850023925241 ()
  • 00850023925244 ()


  • Flexible video choledochoscope, single-use
  • Flexible video ureteroscope, single-use
Single-Use Digital Flexible Ureteroscope/Choledochoscope
Otu Medical Inc.
OTU-OM100SR
In Commercial Distribution

  • 10850023925234 ()
  • 00850023925237 ()


  • Flexible video choledochoscope, single-use
  • Flexible video ureteroscope, single-use
Single-Use Digital Flexible Cystoscope
Otu Medical Inc.
OTU-C310R
In Commercial Distribution

  • 10850023925197 ()
  • 00850023925190 ()
  • 20850023925194 ()
  • 30850023925191 ()


  • Flexible video cystoscope, single-use
Single-Use Digital Flexible Cystoscope
Otu Medical Inc.
OTU-C310S
In Commercial Distribution

  • 10850023925180 ()
  • 00850023925183 ()
  • 20850023925187 ()
  • 30850023925184 ()


  • Flexible video cystoscope, single-use
Single-Use Digital Flexible Cystoscope
Otu Medical Inc.
OTU-C300R
In Commercial Distribution

  • 10850023925173 ()
  • 00850023925176 ()
  • 20850023925170 ()


  • Flexible video cystoscope, single-use
Single-Use Digital Flexible Cystoscope
Otu Medical Inc.
OTU-C300S
In Commercial Distribution

  • 10850023925166 ()
  • 00850023925169 ()
  • 20850023925163 ()


  • Flexible video cystoscope, single-use
Single-Use Digital Flexible UroScope
Otu Medical Inc.
OTU-C380SR
In Commercial Distribution

  • 10850023925159 ()
  • 00850023925152 ()
4102C0401T

  • Flexible video ureteroscope, single-use
Single-Use Digital Flexible Uroscope
Otu Medical Inc.
OTU-C380SL
In Commercial Distribution

  • 00850023925145 ()
  • 10850023925142 ()
4102C0301T

  • Flexible video ureteroscope, single-use
Single-Use Digital Flexible UroScope
Otu Medical Inc.
OTU-C380RR
In Commercial Distribution

  • 00850023925138 ()
  • 10850023925135 ()
4102C0201T

  • Flexible video ureteroscope, single-use
Single-Use Digital Flexible UroScope
Otu Medical Inc.
OTU-C380RL
In Commercial Distribution

  • 10850023925128 ()
  • 00850023925121 ()
4102C0101T

  • Flexible video ureteroscope, single-use
Single-Use Digital Flexible Ureteroscope
Otu Medical Inc.
OTU-100SR
In Commercial Distribution

  • 10850023925074 ()
  • 00850023925077 ()
4101U0401T

  • Flexible video ureteroscope, single-use
Single-Use Digital Flexible Ureteroscope
Otu Medical Inc.
OTU-100SL
In Commercial Distribution

  • 10850023925067 ()
  • 00850023925060 ()
4101U0301T

  • Flexible video ureteroscope, single-use
Single-Use Digital Flexible Ureteroscope
Otu Medical Inc.
OTU-100RR
In Commercial Distribution

  • 10850023925050 ()
  • 00850023925053 ()
4101U0201T

  • Flexible video ureteroscope, single-use
Single-Use Digital Flexible Ureteroscope
Otu Medical Inc.
OTU-100RL
In Commercial Distribution

  • 10850023925043 ()
  • 00850023925046 ()
4101U0101T

  • Flexible video ureteroscope, single-use
Single-Use Digital Flexible Ureteroscope
Otu Medical Inc.
BDRD01
In Commercial Distribution

  • 10850023925036 ()
  • 00850023925039 ()


  • Flexible video ureteroscope, single-use
Single-Use Digital Flexible Ureteroscope
Otu Medical Inc.
BDSD01
In Commercial Distribution

  • 10850023925029 ()
  • 00850023925022 ()


  • Flexible video ureteroscope, single-use
Hexa Surgical Blade #15 Stainless Steel (100)
Hexa Dental
PSS15
In Commercial Distribution

  • 00850023750990 ()


  • Manual surgical saw blade, flexible, single-use
Hexa Surgical Blade #12D Stainless Steel (100)
Hexa Dental
PSS12D
In Commercial Distribution

  • 00850023750983 ()


  • Manual surgical saw blade, flexible, single-use
Hexa Surgical Blade #12 Stainless Steel (100)
Hexa Dental
PSS12
In Commercial Distribution

  • 00850023750976 ()


  • Manual surgical saw blade, flexible, single-use
Hexa Surgical Blade #11 Stainless Steel (100)
Hexa Dental
PSS11
In Commercial Distribution

  • 00850023750969 ()


  • Manual surgical saw blade, flexible, single-use
Hexa Surgical Blade #25 Carbon Steel
Hexa Dental
PCS25
In Commercial Distribution

  • 00850023750945 ()


  • Manual surgical saw blade, flexible, single-use
Hexa Surgical Blade #21 Carbon Steel (100)
Hexa Dental
PCS21
In Commercial Distribution

  • 00850023750938 ()


  • Manual surgical saw blade, flexible, single-use
Hexa Surgical Blade #15C Carbon Steel (100)
Hexa Dental
PCS15C
In Commercial Distribution

  • 00850023750921 ()


  • Manual surgical saw blade, flexible, single-use
Hexa Surgical Blade #15 Carbon Steel (100)
Hexa Dental
PCS15
In Commercial Distribution

  • 00850023750914 ()


  • Manual surgical saw blade, flexible, single-use
Hexa Surgical Blade #12D Carbon Steel (100)
Hexa Dental
PCS12D
In Commercial Distribution

  • 00850023750907 ()


  • Manual surgical saw blade, flexible, single-use
Hexa Surgical Blade #12 Carbon Steel (100)
Hexa Dental
PCS12
In Commercial Distribution

  • 00850023750891 ()


  • Manual surgical saw blade, flexible, single-use
Hexa Surgical Blade #11 Carbon Steel (100)
Hexa Dental
PCS11
In Commercial Distribution

  • 00850023750884 ()


  • Manual surgical saw blade, flexible, single-use
Hexa Surgical Blade #10 Carbon Steel (100)
Hexa Dental
PCS10
In Commercial Distribution

  • 00850023750877 ()


  • Manual surgical saw blade, flexible, single-use
Stieber Kit: Two Piece Horizontal Bar, Two vertical poles and two Grooved 3D Swinger Clamps
Automated Medical Products Corp.
Stieber Rib Grip Kit
In Commercial Distribution

  • 00850023646927 ()
SBRBKC

  • Surgical retraction system, reusable
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