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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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Edge One Platinum - 00819514020691

Endodontic Reciprocating Files
US ENDODONTICS, LLC
EOPSM31
In Commercial Distribution

  • 10819514020698 ()
  • 00819514020691 ()
EOPSM31

  • Rotary/reciprocating endodontic file/rasp, single-use

Edge One Platinum - 00819514020677

Endodontic Reciprocating Files
US ENDODONTICS, LLC
EOPSM21
In Commercial Distribution

  • 10819514020674 ()
  • 00819514020677 ()
EOPSM21

  • Rotary/reciprocating endodontic file/rasp, single-use

Edge One Platinum - 00819514020660

Endodontic Reciprocating Files
US ENDODONTICS, LLC
EOPVER31
In Commercial Distribution

  • 10819514020667 ()
  • 00819514020660 ()
EOPVER31

  • Rotary/reciprocating endodontic file/rasp, single-use

Edge One Platinum - 00819514020653

Endodontic Reciprocating Files
US ENDODONTICS, LLC
EOPVER25
In Commercial Distribution

  • 10819514020650 ()
  • 00819514020653 ()
EOPVER25

  • Rotary/reciprocating endodontic file/rasp, single-use

Edge One Platinum - 00819514020646

Endodontic Reciprocating Files
US ENDODONTICS, LLC
EOPVER21
In Commercial Distribution

  • 10819514020643 ()
  • 00819514020646 ()
EOPVER21

  • Rotary/reciprocating endodontic file/rasp, single-use

HBW A ONE - 00816073021237

Sterile, disposable, surgical stainless steel Chinese style acupuncture needles have a wire wound metal handle with loop for easy manipulation. 1 needle per guide tube with a color coded tab to hold the needle in place. Box of 200. Size:30Gauge x 75mm (3.0")
HEALTH BODY WORLD SUPPLY, INC.
A Type No.30G x 75mm(3.0")
In Commercial Distribution

  • 20816073021231 ()
  • 00816073021237 ()
  • 10816073021234 ()

  • 0.30 x 75mm
AA3030

  • Acupuncture needle, single-use

HBW A ONE - 00816073021220

Sterile, disposable, surgical stainless steel Chinese style acupuncture needles have a wire wound metal handle with loop for easy manipulation. 1 needle per guide tube with a color coded tab to hold the needle in place. Box of 200. Size:32Gauge x 75mm (3.0")
HEALTH BODY WORLD SUPPLY, INC.
A Type No.32G x 75mm(3.0")
In Commercial Distribution

  • 10816073021227 ()
  • 00816073021220 ()
  • 20816073021224 ()

  • 0.25 x 75mm
AA3230

  • Acupuncture needle, single-use

HBW A ONE - 00816073021213

Sterile, disposable, surgical stainless steel Chinese style acupuncture needles have a wire wound metal handle with loop for easy manipulation. 1 needle per guide tube with a color coded tab to hold the needle in place. Box of 200. Size:30Gauge x 50mm (2.0")
HEALTH BODY WORLD SUPPLY, INC.
A Type No.30G x 50mm(2.0")
In Commercial Distribution

  • 20816073021217 ()
  • 00816073021213 ()
  • 10816073021210 ()

  • 0.30 x 50mm
AA3020

  • Acupuncture needle, single-use

HBW A ONE - 00816073021206

Sterile, disposable, surgical stainless steel Chinese style acupuncture needles have a wire wound metal handle with loop for easy manipulation. 1 needle per guide tube with a color coded tab to hold the needle in place. Box of 200. Size:32Gauge x 50mm (2.0")
HEALTH BODY WORLD SUPPLY, INC.
A Type No.32G x 50mm(2.0")
In Commercial Distribution

  • 20816073021200 ()
  • 00816073021206 ()
  • 10816073021203 ()

  • 0.25 x 50mm
AA3220

  • Acupuncture needle, single-use

HBW A ONE - 00816073021190

Sterile, disposable, surgical stainless steel Chinese style acupuncture needles have a wire wound metal handle with loop for easy manipulation. 1 needle per guide tube with a color coded tab to hold the needle in place. Box of 200. Size:34Gauge x 50mm (2.0")
HEALTH BODY WORLD SUPPLY, INC.
A Type No.34G x 50mm(2.0")
In Commercial Distribution

  • 10816073021197 ()
  • 00816073021190 ()
  • 20816073021194 ()

  • 0.22 x 50mm
AA3420

  • Acupuncture needle, single-use

HBW A ONE - 00816073021183

Sterile, disposable, surgical stainless steel Chinese style acupuncture needles have a wire wound metal handle with loop for easy manipulation. 1 needle per guide tube with a color coded tab to hold the needle in place. Box of 200. Size:36Gauge x 50mm (2.0")
HEALTH BODY WORLD SUPPLY, INC.
A Type No.36G x 50mm(2.0")
In Commercial Distribution

  • 10816073021180 ()
  • 00816073021183 ()
  • 20816073021187 ()

  • 0.20 x 50mm
AA3620

  • Acupuncture needle, single-use

HBW A ONE - 00816073021176

Sterile, disposable, surgical stainless steel Chinese style acupuncture needles have a wire wound metal handle with loop for easy manipulation. 1 needle per guide tube with a color coded tab to hold the needle in place. Box of 200. Size:30Gauge x 40mm (1.5")
HEALTH BODY WORLD SUPPLY, INC.
A Type No.30G x 40mm(1.5")
In Commercial Distribution

  • 20816073021170 ()
  • 00816073021176 ()
  • 10816073021173 ()

  • 0.30 x 40mm
AA3015

  • Acupuncture needle, single-use

HBW A ONE - 00816073021169

Sterile, disposable, surgical stainless steel Chinese style acupuncture needles have a wire wound metal handle with loop for easy manipulation. 1 needle per guide tube with a color coded tab to hold the needle in place. Box of 200. Size:32Gauge x 40mm (1.5")
HEALTH BODY WORLD SUPPLY, INC.
A Type No.32G x 40mm(1.5")
In Commercial Distribution

  • 20816073021163 ()
  • 00816073021169 ()
  • 10816073021166 ()

  • 0.25 x 40mm
AA3215

  • Acupuncture needle, single-use

HBW A ONE - 00816073021152

Sterile, disposable, surgical stainless steel Chinese style acupuncture needles have a wire wound metal handle with loop for easy manipulation. 1 needle per guide tube with a color coded tab to hold the needle in place. Box of 200. Size:34Gauge x 40mm (1.5")
HEALTH BODY WORLD SUPPLY, INC.
A Type No.34G x 40mm(1.5")
In Commercial Distribution

  • 10816073021159 ()
  • 00816073021152 ()
  • 20816073021156 ()

  • 0.22 x 40mm
AA3415

  • Acupuncture needle, single-use

HBW A ONE - 00816073021145

Sterile, disposable, surgical stainless steel Chinese style acupuncture needles have a wire wound metal handle with loop for easy manipulation. 1 needle per guide tube with a color coded tab to hold the needle in place. Box of 200. Size:36Gauge x 40mm (1.5")
HEALTH BODY WORLD SUPPLY, INC.
A Type No.36G x 40mm(1.5")
In Commercial Distribution

  • 10816073021142 ()
  • 00816073021145 ()
  • 20816073021149 ()

  • 0.20 x 40mm
AA3615

  • Acupuncture needle, single-use

HBW A ONE - 00816073021138

Sterile, disposable, surgical stainless steel Chinese style acupuncture needles have a wire wound metal handle with loop for easy manipulation. 1 needle per guide tube with a color coded tab to hold the needle in place. Box of 200. Size:38Gauge x 40mm (1.5")
HEALTH BODY WORLD SUPPLY, INC.
A Type No.38G x 40mm(1.5")
In Commercial Distribution

  • 20816073021132 ()
  • 00816073021138 ()
  • 10816073021135 ()

  • 0.18 x 40mm
AA3815

  • Acupuncture needle, single-use

HBW A ONE - 00816073021121

Sterile, disposable, surgical stainless steel Chinese style acupuncture needles have a wire wound metal handle with loop for easy manipulation. 1 needle per guide tube with a color coded tab to hold the needle in place. Box of 200. Size:30Gauge x 25mm (1.0")
HEALTH BODY WORLD SUPPLY, INC.
A Type No.30G x 25mm(1.0")
In Commercial Distribution

  • 20816073021125 ()
  • 00816073021121 ()
  • 10816073021128 ()

  • 0.30 x 25mm
AA3010

  • Acupuncture needle, single-use

HBW A ONE - 00816073021114

Sterile, disposable, surgical stainless steel Chinese style acupuncture needles have a wire wound metal handle with loop for easy manipulation. 1 needle per guide tube with a color coded tab to hold the needle in place. Box of 200. Size:32Gauge x 25mm (1.0")
HEALTH BODY WORLD SUPPLY, INC.
A Type No.32G x 25mm(1.0")
In Commercial Distribution

  • 10816073021111 ()
  • 00816073021114 ()
  • 20816073021118 ()

  • 0.25 x 25mm
AA3210

  • Acupuncture needle, single-use

HBW A ONE - 00816073021107

Sterile, disposable, surgical stainless steel Chinese style acupuncture needles have a wire wound metal handle with loop for easy manipulation. 1 needle per guide tube with a color coded tab to hold the needle in place. Box of 200. Size:34Gauge x 25mm (1.0")
HEALTH BODY WORLD SUPPLY, INC.
A Type No.34G x 25mm(1.0")
In Commercial Distribution

  • 10816073021104 ()
  • 00816073021107 ()
  • 20816073021101 ()

  • 0.22 x 25mm
AA3410

  • Acupuncture needle, single-use

HBW A ONE - 00816073021091

Sterile, disposable, surgical stainless steel Chinese style acupuncture needles have a wire wound metal handle with loop for easy manipulation. 1 needle per guide tube with a color coded tab to hold the needle in place. Box of 200. Size:36Gauge x 25mm (1.0")
HEALTH BODY WORLD SUPPLY, INC.
A Type No.36G x 25mm(1.0")
In Commercial Distribution

  • 10816073021098 ()
  • 00816073021091 ()
  • 20816073021095 ()

  • 0.20 x 25mm
AA3610

  • Acupuncture needle, single-use

HBW A ONE - 00816073021084

Sterile, disposable, surgical stainless steel Chinese style acupuncture needles have a wire wound metal handle with loop for easy manipulation. 1 needle per guide tube with a color coded tab to hold the needle in place. Box of 200. Size:38Gauge x 25mm (1.0")
HEALTH BODY WORLD SUPPLY, INC.
A Type No.38G x 25mm(1.0")
In Commercial Distribution

  • 10816073021081 ()
  • 00816073021084 ()
  • 20816073021088 ()

  • 0.18 x 25mm
AA3810

  • Acupuncture needle, single-use

HBW A ONE - 00816073021077

Sterile, disposable, surgical stainless steel Chinese style acupuncture needles have a wire wound metal handle with loop for easy manipulation. 1 needle per guide tube with a color coded tab to hold the needle in place. Box of 200. Size:40Gauge x 25mm (1.0")
HEALTH BODY WORLD SUPPLY, INC.
A Type No.40G x 25mm(1.0")
In Commercial Distribution

  • 20816073021071 ()
  • 00816073021077 ()
  • 10816073021074 ()

  • 0.16 x 25mm
AA4010

  • Acupuncture needle, single-use

HBW A ONE - 00816073021060

Sterile, disposable, surgical stainless steel Chinese style acupuncture needles have a wire wound metal handle with loop for easy manipulation. 1 needle per guide tube with a color coded tab to hold the needle in place. Box of 200. Size:32Gauge x 13mm (0.5")
HEALTH BODY WORLD SUPPLY, INC.
A Type No.32G x 13mm(0.5")
In Commercial Distribution

  • 20816073021064 ()
  • 00816073021060 ()
  • 10816073021067 ()

  • 0.25 x 13mm
AA3205

  • Acupuncture needle, single-use

HBW A ONE - 00816073021053

Sterile, disposable, surgical stainless steel Chinese style acupuncture needles have a wire wound metal handle with loop for easy manipulation. 1 needle per guide tube with a color coded tab to hold the needle in place. Box of 200. Size:34Gauge x 13mm (0.5")
HEALTH BODY WORLD SUPPLY, INC.
A Type No.34G x 13mm(0.5")
In Commercial Distribution

  • 20816073021057 ()
  • 00816073021053 ()
  • 10816073021050 ()

  • 0.22 x 13mm
AA3405

  • Acupuncture needle, single-use

HBW A ONE - 00816073021046

Sterile, disposable, surgical stainless steel Chinese style acupuncture needles have a wire wound metal handle with loop for easy manipulation. 1 needle per guide tube with a color coded tab to hold the needle in place. Box of 200. Size:36Gauge x 13mm (0.5")
HEALTH BODY WORLD SUPPLY, INC.
A Type No.36G x 13mm(0.5")
In Commercial Distribution

  • 10816073021043 ()
  • 00816073021046 ()
  • 20816073021040 ()

  • 0.20 x 13mm
AA3605

  • Acupuncture needle, single-use

HBW A ONE - 00816073021039

Sterile, disposable, surgical stainless steel Chinese style acupuncture needles have a wire wound metal handle with loop for easy manipulation. 1 needle per guide tube with a color coded tab to hold the needle in place. Box of 200. Size:38Gauge x 13mm (0.5")
HEALTH BODY WORLD SUPPLY, INC.
A Type No.38G x 13mm(0.5")
In Commercial Distribution

  • 10816073021036 ()
  • 00816073021039 ()
  • 20816073021033 ()

  • 0.18 x 13mm
AA3805

  • Acupuncture needle, single-use

HBW A ONE - 00816073021022

Sterile, disposable, surgical stainless steel Chinese style acupuncture needles have a wire wound metal handle with loop for easy manipulation. 1 needle per guide tube with a color coded tab to hold the needle in place. Box of 200. Size:40Gauge x 13mm (0.5")
HEALTH BODY WORLD SUPPLY, INC.
A Type No.40G x 13mm(0.5")
In Commercial Distribution

  • 10816073021029 ()
  • 00816073021022 ()
  • 20816073021026 ()

  • 0.16 x 13mm
AA4005

  • Acupuncture needle, single-use

LEVEL ONE, STERILE - 00888118121639

TWIST DRILL, J NOTCH, 30 MM STOP, 25 MM FLUTE
KLS-Martin L.P.
25-469-11-71
In Commercial Distribution

  • 00888118121639 ()

  • 1.5 X 115 MM


  • Fluted surgical drill bit, single-use

LEVEL ONE, STERILE - 00888118121622

TWIST DRILL, J NOTCH, 17 MM STOP
KLS-Martin L.P.
25-452-00-71
In Commercial Distribution

  • 00888118121622 ()

  • 1.1 X 50 MM


  • Fluted surgical drill bit, single-use

LEVEL ONE, STERILE - 00888118121615

TWIST DRILL, J NOTCH, 21 MM STOP
KLS-Martin L.P.
25-449-16-71
In Commercial Distribution

  • 00888118121615 ()

  • 1.5 X 50 MM


  • Fluted surgical drill bit, single-use

LEVEL ONE TRANSBUCCAL - 00888118120069

RETRACTOR, CHEEK, MAXDRIVE, RING, KIM, SELF RETAINING, FOR 25-486-97-07,
KLS-Martin L.P.
99-594-99-03
In Commercial Distribution

  • 00888118120069 ()

  • 21 MM


  • Orthopaedic trocar blade, reusable

LEVEL ONE TRANSBUCCAL - 00888118119766

RETRACTOR, CHEEK, W/FIBER OPTIC CLIP, AND RING, FOR 50-501-XX
KLS-Martin L.P.
99-590-45-01
In Commercial Distribution

  • 00888118119766 ()

  • 85 MM


  • Orthopaedic trocar blade, reusable

LEVEL ONE TRANSBUCCAL - 00888118118288

CANNULA, MARX, FOR 50-501-XX-07
KLS-Martin L.P.
995-3903-01
In Commercial Distribution

  • 00888118118288 ()

  • 48 MM


  • Orthopaedic trocar blade, reusable

LEVEL ONE TRANSBUCCAL - 00888118117991

TROCAR, X FIX, FOR 995-2950-01
KLS-Martin L.P.
995-2950-02
In Commercial Distribution

  • 00888118117991 ()

  • 71 MM


  • Orthopaedic trocar blade, reusable

LEVEL ONE TRANSBUCCAL - 00888118117984

CANNULA, X FIX, SINGLE POINTED, FOR 50-501-XX-07
KLS-Martin L.P.
995-2950-01
In Commercial Distribution

  • 00888118117984 ()

  • 58 MM


  • Orthopaedic trocar blade, reusable

LEVEL ONE CMF - 00888118117953

No Description
KLS-Martin L.P.
51-671-27-09
Not in Commercial Distribution

  • 00888118117953 ()


  • Surgical implant template, single-use

LEVEL ONE TRANSBUCCAL - 00888118117922

TROCAR, 2.7 MM, FOR 50-090-05-07
KLS-Martin L.P.
50-090-15-07
In Commercial Distribution

  • 00888118117922 ()


  • Orthopaedic trocar blade, reusable

LEVEL ONE TRANSBUCCAL - 00888118116970

DRILL GUIDE, 2.0-2.5 MM, TLTS, FOR DOUBLE THREADED PLATES
KLS-Martin L.P.
99-577-60-05
In Commercial Distribution

  • 00888118116970 ()

  • 54 MM


  • Surgical drill guide, reusable

LEVEL ONE TRANSBUCCAL - 00888118116963

CANNULA, 2.0-2.5 MM, TLTS, FOR DOUBLE THREADED PLATES
KLS-Martin L.P.
99-577-60-01
In Commercial Distribution

  • 00888118116963 ()

  • 54 MM


  • Orthopaedic trocar blade, reusable

LEVEL ONE CMF - 00888118116895

COMPLETE, MIDFACE FIXATION SET, V3
KLS-Martin L.P.
55-969-71-04
In Commercial Distribution

  • 00888118116895 ()


  • Surgical instrument/implant rack

LEVEL ONE CMF - 00888118113863

SCREW, MAXDRIVE, TLTS, TAPERED, TI-6AL-4V
KLS-Martin L.P.
99-594-30-06
Not in Commercial Distribution

  • 00888118113863 ()

  • 2.3 X 13 MM


  • Craniofacial bone screw, non-bioabsorbable

LEVEL ONE CMF - 00888118113856

SCREW, MAXDRIVE, TLTS, TAPERED, TI-6AL-4V
KLS-Martin L.P.
99-594-30-05
Not in Commercial Distribution

  • 00888118113856 ()

  • 2.3 X 11 MM


  • Craniofacial bone screw, non-bioabsorbable

LEVEL ONE CMF - 00888118113849

SCREW, MAXDRIVE, TLTS, TAPERED, TI-6AL-4V
KLS-Martin L.P.
99-594-30-04
Not in Commercial Distribution

  • 00888118113849 ()

  • 2.3 X 9 MM


  • Craniofacial bone screw, non-bioabsorbable

LEVEL ONE CMF - 00888118113832

SCREW, MAXDRIVE, TLTS, TAPERED, TI-6AL-4V
KLS-Martin L.P.
99-594-30-03
Not in Commercial Distribution

  • 00888118113832 ()

  • 2.0 X 13 MM


  • Craniofacial bone screw, non-bioabsorbable

LEVEL ONE CMF - 00888118113825

SCREW, MAXDRIVE, TLTS, TAPERED, TI-6AL-4V
KLS-Martin L.P.
99-594-30-02
Not in Commercial Distribution

  • 00888118113825 ()

  • 2.0 X 11 MM


  • Craniofacial bone screw, non-bioabsorbable

LEVEL ONE CMF - 00888118113818

SCREW, MAXDRIVE, TLTS, TAPERED, TI-6AL-4V
KLS-Martin L.P.
99-594-30-01
Not in Commercial Distribution

  • 00888118113818 ()

  • 2.0 X 9 MM


  • Craniofacial bone screw, non-bioabsorbable

LEVEL ONE CMF - 00888118113733

SCREW, CENTREDRIVE, EMERGENCY, TI-6AL-4V
KLS-Martin L.P.
25-661-07-61
In Commercial Distribution

  • 00888118113733 ()

  • 1.2 X 7 MM


  • Craniofacial bone screw, non-bioabsorbable

LEVEL ONE CMF - 00888118113726

SCREW, CENTREDRIVE, EMERGENCY, TI-6AL-4V
KLS-Martin L.P.
25-661-05-61
In Commercial Distribution

  • 00888118113726 ()

  • 1.2 X 5 MM


  • Craniofacial bone screw, non-bioabsorbable

LEVEL ONE THORACIC - 00888118119391

FORCEPS, RIB, SMALL BOX
KLS-Martin L.P.
99-582-74-01
In Commercial Distribution

  • 00888118119391 ()

  • 163 MM


  • Bone fixation plate pliers

LEVEL ONE CMF - 00888118119186

No Description
KLS-Martin L.P.
99-578-44-01
Not in Commercial Distribution

  • 00888118119186 ()

  • 48 MM


  • Orthopaedic trocar blade, reusable
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