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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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Interbody Fusion Device 7DEG x 22L x 10W x 9H
CAMBER SPINE TECHNOLOGIES, LLC
Interbody Fusion Device 7DEG x 22L x 10W x 9H
In Commercial Distribution

  • B030CX2210090 ()
CX-221009

  • Polymeric spinal interbody fusion cage
Interbody Fusion Device 7DEG x 22L x 10W x 7H
CAMBER SPINE TECHNOLOGIES, LLC
Interbody Fusion Device 7DEG x 22L x 10W x 7H
In Commercial Distribution

  • B030CX2210070 ()
CX-221007

  • Polymeric spinal interbody fusion cage
No Description
Tyber Medical LLC
PLIF 28mm x 8mm x 15mm x 0 °, TyPEEK, Sterile
In Commercial Distribution

  • M695502P281508S1 ()
502-P281508-S

  • Metal-polymer composite spinal interbody fusion cage
No Description
Tyber Medical LLC
PLIF 26mm x 12mm x 15mm x 8 °, TyPEEK, Sterile
In Commercial Distribution

  • M695502P2615812S1 ()
502-P2615812S-S

  • Metal-polymer composite spinal interbody fusion cage
No Description
Tyber Medical LLC
PLIF 24mm x 10mm x 7mm x 8 °, TyPEEK, Sterile
In Commercial Distribution

  • M695502P247810S1 ()
502P247810S

  • Metal-polymer composite spinal interbody fusion cage
No Description
Tyber Medical LLC
PLIF 22mm x 10mm x 9mm x 8 °, TyPEEK, Sterile
In Commercial Distribution

  • M695502P229810S1 ()
502-P229810-S

  • Metal-polymer composite spinal interbody fusion cage
No Description
Tyber Medical LLC
PLIF 30mm x 12mm x 15mm x 2 °, PEEK, Sterile
In Commercial Distribution

  • M695302P301521S1 ()
302-P301521S-S

  • Metal-polymer composite spinal interbody fusion cage
No Description
Tyber Medical LLC
PLIF 28mm x 10mm x 11mm x 0 °, PEEK, Sterile
In Commercial Distribution

  • M695302P2811010S1 ()
302P2811010S

  • Metal-polymer composite spinal interbody fusion cage
No Description
Tyber Medical LLC
PLIF 28mm x 10mm x 10mm x 0 °, PEEK, Sterile
In Commercial Distribution

  • M695302P2810010S0 ()
302P2810010S

  • Metal-polymer composite spinal interbody fusion cage
No Description
Tyber Medical LLC
PLIF 22mm x 8mm x 8mm x 0 °, PEEK, Sterile
In Commercial Distribution

  • M695302P22808S1 ()
302-P22808S

  • Metal-polymer composite spinal interbody fusion cage
No Description
Tyber Medical LLC
PLIF 28mm x 12mm x 17mm x 0 °, PEEK, Sterile
In Commercial Distribution

  • M69502P2817012S1 ()
02P2817012S

  • Metal-polymer composite spinal interbody fusion cage
ctn
BIOMEDICAL LIFE SYSTEMS, INC.
EBTF375600M
In Commercial Distribution

  • 00857771003910 ()
EBTF375600M

  • Transcutaneous electrical stimulation electrode, single-use
10/bg
BIOMEDICAL LIFE SYSTEMS, INC.
EBTF375600M
In Commercial Distribution

  • 00857771003866 ()
EBTF375600M

  • Transcutaneous electrical stimulation electrode, single-use
1 Pouch - 10 Packs / Pouch. 4 Each / PaCK.
BIOMEDICAL LIFE SYSTEMS, INC.
EERC200M
In Commercial Distribution

  • 00857771003590 ()
EERC200M

  • Transcutaneous electrical stimulation electrode, single-use
4" x 7" pigtail electrode
BIOMEDICAL LIFE SYSTEMS, INC.
EERC400700
In Commercial Distribution

  • 00857771003316 ()
  • 10857771003313 ()
EERC400700

  • Transcutaneous electrical stimulation electrode, single-use
ea
BIOMEDICAL LIFE SYSTEMS, INC.
EBTF357600M
Not in Commercial Distribution

  • 00857771003279 ()
EBTF357600M

  • Transcutaneous electrical stimulation electrode, single-use
1 Pack - 4 Electrodes / Pack
BIOMEDICAL LIFE SYSTEMS, INC.
EERC200M
In Commercial Distribution

  • 00857771003002 ()
EERC200M

  • Transcutaneous electrical stimulation electrode, single-use
HemCon ChitoGauzeXR PRO is a hemostatic dressing for the external, temporary control of severely bleeding wounds.
TRICOL BIOMEDICAL, INC.
1
In Commercial Distribution

  • 20870053000562 ()
  • 00870053000568 ()
  • 50870053000563 ()
1020

  • Chitosan haemostatic agent, professional, non-bioabsorbable
ChitoGauze is intended for temporary external use to stop bleeding in minor wounds.
TRICOL BIOMEDICAL, INC.
1
In Commercial Distribution

  • 50870053000303 ()
  • 00870053000308 ()
1025

  • Chitosan haemostatic agent, professional, non-bioabsorbable
PosiSep X2 devices are patient-comfortable sponges manufactured from naturally occurring Chitosan polymers. PosiSep X2 devices expand when hydrated providing separation between the sinus tissues.
HEMOSTASIS, LLC
9210615
In Commercial Distribution

  • 00858439001910 ()
  • 00858439001903 ()

  • Width: 0.8 Inch
  • Length: 2.3 Inch


  • Chitosan haemostatic agent, professional, non-bioabsorbable
No Description
Emsi
A2011
In Commercial Distribution

  • 00858688006322 ()


  • Transcutaneous electrical stimulation electrode, single-use
No Description
Emsi
ELEC0012
In Commercial Distribution

  • 00858688006056 ()


  • Transcutaneous electrical stimulation electrode, single-use
PosiSep X2 devices are patient-comfortable sponges manufactured from naturally occurring Chitosan polymers. PosiSep X2 devices expand when hydrated providing separation between the sinus tissues.
HEMOSTASIS, LLC
9210614
In Commercial Distribution

  • 00858439001880 ()
  • 00858439001897 ()

  • Width: 0.7 Inch
  • Length: 1.7 Inch


  • Chitosan haemostatic agent, professional, non-bioabsorbable
PosiSep C 0.6 x 2.0 devices are patient-comfortable sponges manufactured from naturally occurring Chitosan polymers. PosiSep C 0.6 x 2.0 devices were specifically engineered for use as a nasal dressing to be used following clinic based procedures.
HEMOSTASIS, LLC
9210854
In Commercial Distribution

  • 00858439001682 ()
  • 00858439001675 ()

  • Width: .64 Inch
  • Length: 2.0 Inch


  • Chitosan haemostatic agent, professional, non-bioabsorbable
  • Intranasal splint, non-bioabsorbable, animal-derived
No Description
Emsi
ELEC407001B
In Commercial Distribution

  • 00859718007081 ()


  • Transcutaneous electrical stimulation electrode, single-use
No Description
Biomet Orthopedics, LLC
472370
In Commercial Distribution

  • 00880304385382 ()
472370

  • Fluted surgical drill bit, reusable
No Description
Biomet Orthopedics, LLC
471338
In Commercial Distribution

  • 00880304383067 ()
471338

  • Medullary canal orthopaedic reamer, rigid
No Description
Biomet Orthopedics, LLC
471336
In Commercial Distribution

  • 00880304383050 ()
471336

  • Medullary canal orthopaedic reamer, rigid
No Description
Biomet Orthopedics, LLC
471334
In Commercial Distribution

  • 00880304383043 ()
471334

  • Medullary canal orthopaedic reamer, rigid
No Description
Biomet Orthopedics, LLC
471330
In Commercial Distribution

  • 00880304383029 ()
471330

  • Medullary canal orthopaedic reamer, rigid
No Description
Biomet Orthopedics, LLC
24415
In Commercial Distribution

  • 00880304520547 ()

  • .062" DIA X 8" LONG
24415

  • Surgical drill guide, reusable
No Description
Biomet Orthopedics, LLC
27982
In Commercial Distribution

  • 00880304500464 ()
27982

  • Biopsy drill bit
No Description
Biomet Orthopedics, LLC
906117
In Commercial Distribution

  • 00880304463912 ()
906117

  • Fibreoptic light cable
No Description
Biomet Orthopedics, LLC
27983
In Commercial Distribution

  • 00880304500471 ()
27983

  • Biopsy drill bit
No Description
Biomet Orthopedics, LLC
27961
In Commercial Distribution

  • 00880304489110 ()
27961

  • Fluted surgical drill bit, single-use
No Description
Biomet Orthopedics, LLC
27949
In Commercial Distribution

  • 00880304487024 ()
27949

  • Orthopaedic bone wire
BioStim 2" x 2" Rectangle Electrodes - 10 pouches of 4 each
BIOMEDICAL LIFE SYSTEMS, INC.
EERC200400M
In Commercial Distribution

  • 00850706007304 ()
EERC200400M

  • Transcutaneous electrical stimulation electrode, single-use
DermLite Foto X with Nailio
DermLite LLC
DLFX-NL1
In Commercial Distribution

  • 00855997006890 ()
DLFX-NL1

  • Dermatoscope, optical
No Description
HARD MANUFACTURING CO., INC.
L2070
In Commercial Distribution

  • 00852231007637 ()
  • 00852231007620 ()
L2070

  • Paediatric bed
No Description
HARD MANUFACTURING CO., INC.
752-KPGP
In Commercial Distribution

  • 00852231007453 ()
  • 00852231007446 ()
752-KPGP

  • Paediatric bed
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