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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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Sterile, silicone, chin implant.
Hanson Medical, Inc.
SVCH - 5
In Commercial Distribution

  • B049SVCH50 ()
SVCH - 5

  • Chin prosthesis
No Description
Gebr. Brasseler GmbH & Co. KG
9891.000. 5.A1
In Commercial Distribution

  • E226045201A11 ()
9891.000. 5

  • Sterilizer/disinfector rack instrument-holding insert, reusable
Rotary HP carbide instrument for dental application
M.D.T. - MICRO DIAMOND TECHNOLOGIES LTD.
HPTC00005-5Q
In Commercial Distribution

  • 57291046642011 ()
HP.TC 5

  • Carbide dental bur, reusable
The KC 5 Pressure Adapter: Dimensions - Luer Lock port x 15mm I.D./22mm O.D. x 15mm O/D.
INSTRUMENTATION INDUSTRIES, INCORPORATED
KC 5
In Commercial Distribution

  • M996KC50 ()
KC 5

  • Breathing circuit pressure detection port plug
self-contained biological indicator, 10e5 population, 100-count box
MESA LABORATORIES, INC.
10e5
In Commercial Distribution

  • M985SEZS51 ()
  • M985SEZS50 ()
SEZS/5

  • Biological sterilization indicator
Bishop-Harmon Tissue Forceps, .5mm heavy 1x2 teeth, flat handle with hole pattern, 86mm total length, Titanium
Diamatrix
F445T.5
In Commercial Distribution

  • 00813059015655 ()
F445T.5

  • Ocular hook/spatula/manipulator, reusable
Integra® Miltex® Mirrors, Magnifying, #5, Simple Stem-12 PK
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
67-676/5
In Commercial Distribution

  • H8346767651 ()
  • 10381780501565 ()
  • 00381780501568 ()
67-676/5

  • Dental mirror, reusable
Integra® Miltex® Mirrors, Magnifying, #5, Cone Socket-12 PK
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
67-668/5
In Commercial Distribution

  • H8346766851 ()
  • 10381780501541 ()
  • 00381780501544 ()
67-668/5

  • Dental mirror, reusable
Protectrode™ Disposable Monopolar Needle Electrodes, 1.00" Fine EMG NEEDLE
IMPULSE MEDICAL TECHNOLOGIES, INC.
PRO-25F(5)
In Commercial Distribution

  • 00816022023619 ()
PRO-25F(5)

  • Electromyographic needle electrode, single-use
Protectrode™ Disposable Monopolar Needle Electrodes, 1.50" EMG NEEDLE
IMPULSE MEDICAL TECHNOLOGIES, INC.
PRO-37SAF(5)
In Commercial Distribution

  • 00816022020045 ()
PRO-37SAF(5)

  • Electromyographic needle electrode, single-use
Protectrode™ Disposable Monopolar Needle Electrodes, 1.00" EMG NEEDLE
IMPULSE MEDICAL TECHNOLOGIES, INC.
PRO-25SAF(5)
In Commercial Distribution

  • 00816022020038 ()
PRO-25SAF(5)

  • Electromyographic needle electrode, single-use
Mirrors, #5, Plane Surface, Simple Stem-12/PK
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
67-672/5
Not in Commercial Distribution

  • H8346767251 ()
  • 10381780472247 ()
  • 00381780472240 ()
67-672/5

  • Dental mirror, reusable
Mirrors, #5, Front Surface, Cone Socket-12/PK
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
67-696/5
Not in Commercial Distribution

  • H8346769651 ()
  • 10381780471929 ()
  • 00381780471922 ()
67-696/5

  • Dental mirror, reusable
Mirrors, #5, Plane Surface, Cone Socket-12/PK
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
67-664/5
Not in Commercial Distribution

  • H8346766451 ()
  • 10381780471677 ()
  • 00381780471670 ()
67-664/5

  • Dental mirror, reusable
Mirrors, #5, Front Surface, Simple Stem-12/PK
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
67-698/5
Not in Commercial Distribution

  • H8346769851 ()
  • 10381780471578 ()
  • 00381780471571 ()
67-698/5

  • Dental mirror, reusable
Diasol Sodium Bicarbonate Powder
DIASOL, INC.
BP10000X10
In Commercial Distribution

  • B467BP4510 ()
  • B467BP4510T1 ()
  • B467BP4510T3 ()
BP4/5

  • Haemodialysis concentrate
self-contained biological indicator, 10e5 population, 100-count box printed in Italian
MESA LABORATORIES, INC.
10e5
In Commercial Distribution

  • M985IDEZS51 ()
  • M985IDEZS50 ()
IDEZS/5

  • Biological sterilization indicator
self-contained biological indicator, 10e5 population, 100-count box
MESA LABORATORIES, INC.
10e5
In Commercial Distribution

  • M985EZS51 ()
  • M985EZS50 ()
EZS/5

  • Biological sterilization indicator
Rotary HP carbide instrument for dental application
M.D.T. - MICRO DIAMOND TECHNOLOGIES LTD.
HPTC00005-15
In Commercial Distribution

  • 07291046641743 ()
HP.TC 5

  • Carbide dental bur, reusable
LARYN MIR W/O HDL SZ5
Bausch & Lomb Incorporated
N7710 5
In Commercial Distribution

  • 00757770432073 ()
N7710 5

  • Laryngeal mirror, reusable
LARYN MIR W/HDL SZ5
Bausch & Lomb Incorporated
N7700 5
In Commercial Distribution

  • 00757770409273 ()
N7700 5

  • Laryngeal mirror, reusable
BERMAN ORAL AIRWAY (100MM) LRG ADLT
GF HEALTH PRODUCTS, INC.
3786-12#5
In Commercial Distribution

  • M36837861250 ()
  • M36837861251 ()
3786-12#5

  • Oropharyngeal airway, reusable
Shaft knob,5mm
mahe medical gmbh
19.80/5
In Commercial Distribution

  • EMAH198050 ()
19.80/5

  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
FCP JEWELERS X-FINE 4 1/4 IN
Bausch & Lomb Incorporated
E1947 5
In Commercial Distribution

  • 00757770460236 ()
E1947 5

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
SILICONE TUBE .040"x.085"x10FT
Bausch & Lomb Incorporated
N5941 5
In Commercial Distribution

  • 00757770428229 ()
N5941 5

  • Ophthalmic irrigation/infusion/aspiration tubing, single-use
SPEC FAR ORIGINAL MDL RND #5
Bausch & Lomb Incorporated
N0226 5
In Commercial Distribution

  • 00757770424757 ()
N0226 5

  • Ear speculum, reusable
CURETTE COAKLEY SM STRNG CVE
Bausch & Lomb Incorporated
N2750 5
In Commercial Distribution

  • 00757770423088 ()
N2750 5

  • Paranasal sinus curette
Neutral Electrode
Leonhard Lang GmbH
RO21 /5
In Commercial Distribution

  • 29005531591527 ()
  • 19005531591520 ()
  • 09005531591523 ()
  • 39005531591524 ()
RO21 /5

  • Electrosurgical return electrode, single-use
No Description
Leonhard Lang GmbH
FS-WA10C /5
In Commercial Distribution

  • 39005531000576 ()
  • 29005531000579 ()
  • 19005531000572 ()
  • 09005531000575 ()
FS-WA10C /5

  • Electrocardiographic electrode, single-use
DBC Sterile, disposable surgical stainless steel intradermal needles. 5 needles in foam per sealed bulk package. Box of 50 needles.
Dong Bang Medical co.,Ltd.
Dbc.Intra.5
In Commercial Distribution

  • 28800018900820 ()
  • 18800018900823 ()
  • 08800018900826 ()

  • 5.0 mm x 12 mm
Dbc.Intra.5

  • Acupuncture needle, single-use
CANNULA CORTEX ANGLED 25GA 5MM
Bausch & Lomb Incorporated
E4931 5
In Commercial Distribution

  • 00757770418794 ()
E4931 5

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
TUBE SUCTION BRACHMAN 5FR
Bausch & Lomb Incorporated
N0606 5
In Commercial Distribution

  • 00757770431144 ()
N0606 5

  • Surgical/emergency suction cannula, non-illuminating, reusable
SUCTION-IRRIG 4X5FR BRACHMAN
Bausch & Lomb Incorporated
N0607 5
In Commercial Distribution

  • 00757770419715 ()
N0607 5

  • Surgical/emergency suction cannula, non-illuminating, reusable
Solventum™ AbThera™ SensaT.R.A.C.™ Open Abdomen Dressing Kit, M8275026/5, 5/PAC
KCI USA, INC.
M8275026/5
In Commercial Distribution

  • 00197998312274 ()
  • 00197998312267 ()
M8275026/5

  • Negative-pressure wound therapy open-abdomen dressing
Solventum™ AbThera™ SensaT.R.A.C.™ Open Abdomen Dressing Kit, M8275026/5, 5/PAC
KCI USA, INC.
M8275026/5
In Commercial Distribution

  • 00197998032615 ()
  • 00197998032608 ()
M8275026/5

  • Negative-pressure wound therapy open-abdomen dressing
Case 5 Starting + 5 Finishing + 5 Heads
INNOMED, INC.
9015
In Commercial Distribution

  • 00840277104618 ()
9015

  • Device sterilization/disinfection container, reusable
Carpal Tunnel Release, (1) SurePass CTR Non-Sterile Blade
Dev4
CT-2003NS
In Commercial Distribution

  • 00860011634836 ()
  • 10860011634833 ()


  • Manual scalpel blade, reusable
Hysteroscopy System indicated for both Hysteroscopy and Cystoscopy to permit direct viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures.
UVISION 360, INC.
LumDTX-A
In Commercial Distribution

  • 00853277008046 ()
20030

  • Flexible video cystoscope, reusable
  • Endoscope sheath, single-use
  • Flexible fibreoptic hysteroscope
Airo™ CPAP Mask Liners - Box of 25 - Large
Athfar 828 Inc
AL-25
In Commercial Distribution

  • 00850054813343 ()
  • 00850054813381 ()


  • General-purpose medical fibre padding
Airo™ CPAP Mask Liners - Box of 25 - Small
Athfar 828 Inc
AS-25
In Commercial Distribution

  • 00850054813350 ()
  • 00850054813374 ()


  • General-purpose medical fibre padding
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