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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ISSA 4 Smile is for use at home and to promote overall oral hygiene by cleaning your teeth and gums only.
Foreo AB
Enchanted Violet
In Commercial Distribution

  • 07350120793041 ()


  • Basic electric toothbrush
ISSA 4 Smile is for use at home and to promote overall oral hygiene by cleaning your teeth and gums only.
Foreo AB
Summer Sky
In Commercial Distribution

  • 07350120793034 ()


  • Basic electric toothbrush
ISSA 4 Smile is for use at home and to promote overall oral hygiene by cleaning your teeth and gums only.
Foreo AB
Wild Strawberry
In Commercial Distribution

  • 07350120793027 ()


  • Basic electric toothbrush
ISSA 4 Plus is for use at home and to promote overall oral hygiene by cleaning your teeth and gums only.
Foreo AB
Lavender
In Commercial Distribution

  • 07350120792983 ()


  • Basic electric toothbrush
ISSA 4 Plus is for use at home and to promote overall oral hygiene by cleaning your teeth and gums only.
Foreo AB
Black
In Commercial Distribution

  • 07350120792976 ()


  • Basic electric toothbrush
The Neotech Bridge is a breastfeeding assistance device intended to deliver supplemental nutrition to an infant latched at the breast/chest
Neotech Products LLC
Bridge Only - 30pcs
In Commercial Distribution

  • 00812594012600 ()
  • 20812594012604 ()
N8001-30

  • Breast pump support kit, reusable
The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
392-0408
In Commercial Distribution

  • 04540778177031 ()

  • Complex (Soft) 10inch 4mm x 8cm
  • Compatible Microcatheter inner diameter: 0.33 to 0.48 Millimeter
392-0408

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil
Utrata Capsulorhexis Forceps With Scale (2 Engravings At 3.00, 6.00 mm), Cystotome Tips, Curved Jaws, Round Handle, Length 110 mm, Titanium
RUMEX INTERNATIONAL CORP.
4-03314T
In Commercial Distribution

  • 00840159904053 ()
4-03314T

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
Utrata Capsulorhexis Forceps With Scale (2 Engravings at 3.00, 6.00 mm), Cystotome Tips, Straight jaws, Round Handle, Length 110 mm, Titanium
RUMEX INTERNATIONAL CORP.
4-03114T
In Commercial Distribution

  • 00840159904039 ()
4-03114T

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
Hampton Needle Holder, Curved, 9mm Jaw, With Lock, Large Knurled Round Handle, Finger Flats At Neck, Overall Length 5-1/8" (130mm)
Med Saver, Inc.
5-4937
In Commercial Distribution

  • 00194613076733 ()


  • Suturing needle holder, reusable
Thrombinator™ System
ARTHREX, INC.
ABS-10080
In Commercial Distribution

  • 00888867286580 ()
ABS-10080

  • Haematological concentrate system preparation kit, thrombin separation
Mayo Extension Bar Flat 1"x6" Bar w/ Hook Mod, for use with Mayo Stand and Crowe Davis Mouth Gag. Instrument is modified to have each end Identical. 3/4" wide hooks at each end and holes cut in for mouth gag use at each end
Avalign Technologies, Inc.
72-3800100M
In Commercial Distribution

  • 00190776214036 ()


  • Rigid optical laryngopharyngoscope
RF Filter Module For CLEARSIGN™ Amplifier
BOSTON SCIENTIFIC CORPORATION
M00420012300
In Commercial Distribution

  • 08714729882961 ()


  • Electronic signal frequency filter
RF Frequency Filter
BOSTON SCIENTIFIC CORPORATION
M0041212H0
In Commercial Distribution

  • 08714729854395 ()


  • Electronic signal frequency filter
RF Frequency Filter
BOSTON SCIENTIFIC CORPORATION
M00412120
In Commercial Distribution

  • 08714729847939 ()


  • Electronic signal frequency filter
Water-based Personal Lubricant
CC Wellness LLC
74027
In Commercial Distribution

  • 10796494002985 ()
  • 00796494002988 ()


  • Sexual lubricant
2x4" rectangle white non-woven fabric cutaneous hydrogel electrode, package contains 4 individual electrodes.
ELITE MEDICAL SUPPLY OF NY
SF50100WP
In Commercial Distribution

  • 00860019001654 ()

  • Length: 4 Inch
  • Width: 2 Inch


  • Interferential electrical stimulation system electrode
2" square white non-woven fabric cutaneous hydrogel electrode, package contains 4 individual electrodes.
ELITE MEDICAL SUPPLY OF NY
SF5050WP
In Commercial Distribution

  • 00860019001616 ()

  • Width: 2 Inch
  • Length: 2 Inch


  • Interferential electrical stimulation system electrode
The Adhesive Electrodes are intended for use as a reusable, conductive adhesive interface between the patient’s skin and the marketed electrical stimulators (i.e. TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) or PGF (Pulsed Galvanic Stimulation) for transmitting electrical current. The electrode is for OTC (Over-The-Counter) or Prescription use.
ADP HEALTH LIMITED
EB2010
In Commercial Distribution

  • 00860012809837 ()
EB2010C21

  • Interferential electrical stimulation system electrode
The Adhesive Electrodes are intended for use as a reusable, conductive adhesive interface between the patient’s skin and the marketed electrical stimulators (i.e. TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) or PGF (Pulsed Galvanic Stimulation) for transmitting electrical current. The electrode is for OTC (Over-The-Counter) or Prescription use.
ADP HEALTH LIMITED
EB2M20
In Commercial Distribution

  • 00860012809820 ()
EB2M20CO2

  • Interferential electrical stimulation system electrode
The Adhesive Electrodes are intended for use as a reusable, conductive adhesive interface between the patient’s skin and the marketed electrical stimulators (i.e. TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) or PGF (Pulsed Galvanic Stimulation) for transmitting electrical current. The electrode is for OTC (Over-The-Counter) or Prescription use.
ADP HEALTH LIMITED
EB2720
In Commercial Distribution

  • 00860012809813 ()
EB2720C21

  • Interferential electrical stimulation system electrode
No Description
EASY HEALTHCARE CORPORATION
ETP101
In Commercial Distribution

  • 10850253007786 ()
  • 00850253007789 ()
  • 30850253007780 ()


  • Interferential electrical stimulation system electrode
No Description
EASY HEALTHCARE CORPORATION
ETP538
In Commercial Distribution

  • 00850253007178 ()
  • 00850253007239 ()
  • 10850253007236 ()


  • Interferential electrical stimulation system electrode
No Description
EASY HEALTHCARE CORPORATION
ETP505
In Commercial Distribution

  • 00850253007161 ()
  • 00850253007222 ()
  • 10850253007229 ()


  • Interferential electrical stimulation system electrode
VECTRA GEN 4C STIM W/O EMG PK
DJO, LLC
2873
In Commercial Distribution

  • 00888912296939 ()


  • Interferential electrical stimulation system electrode
VECTRA GEN 2C STIM W/O EMG PK
DJO, LLC
2871
In Commercial Distribution

  • 00888912296847 ()


  • Interferential electrical stimulation system electrode
LEGEND XT 4CH STIM PKG US STD
DJO, LLC
2786
In Commercial Distribution

  • 00888912294140 ()


  • Interferential electrical stimulation system electrode
VECTRA GENISYS 2CH STIM PKG
DJO, LLC
2764
In Commercial Distribution

  • 00888912293051 ()


  • Interferential electrical stimulation system electrode
Pro Carbon IFC Electrodes - 4" Round 1pair
C.M.P. Canadian Medical Products Inc
C5140
In Commercial Distribution

  • B312C51400 ()


  • Interferential electrical stimulation system electrode
Pro Carbon IFC Electrodes - 3" Round 1pair
C.M.P. Canadian Medical Products Inc
C5130
In Commercial Distribution

  • B312C51300 ()


  • Interferential electrical stimulation system electrode
Pro Carbon IFC Electrodes - 2" Round 1pair
C.M.P. Canadian Medical Products Inc
C5120
In Commercial Distribution

  • B312C51200 ()


  • Interferential electrical stimulation system electrode
No Description
EASY HEALTHCARE CORPORATION
ETP015B
In Commercial Distribution

  • 10810038636129 ()
  • 00810038636122 ()


  • Interferential electrical stimulation system electrode
No Description
EASY HEALTHCARE CORPORATION
ETP019
In Commercial Distribution

  • 10810038634361 ()
  • 00810038634364 ()


  • Interferential electrical stimulation system electrode
No Description
EASY HEALTHCARE CORPORATION
ETP538
In Commercial Distribution

  • 00810038630052 ()


  • Interferential electrical stimulation system electrode
No Description
EASY HEALTHCARE CORPORATION
ETP505
In Commercial Distribution

  • 00810038630038 ()


  • Interferential electrical stimulation system electrode
COVER GOWN 100%C UNBLEACHED L W/Tie Closures at Neck and Self Waist Ties Raglan Long Sleeves w/Natural Poly Cuffs
STANDARD TEXTILE CO., INC.
74103400
Not in Commercial Distribution

  • 00634916194173 ()
  • 10634916194173 ()
74103400

  • Isolation gown, reusable
Atrium Health At Home O2 Kit This kit contains: (2) RES001, (1) RES012 , (2) RES018, (6) RES1107S, (2) RES3040G, and (1) RES003
SUNSET HEALTHCARE SOLUTIONS, INC.
ATRIUMO2KIT-10
In Commercial Distribution

  • 00848530104528 ()
  • 00848530104504 ()


  • Oxygen administration kit
This light therapy prescription-strength powerhouse banishes blemishes at their core with a larger treatment head bringing the dermatologist into your living room.
QUASAR BIO-TECH INC.
DPA-022
In Commercial Distribution

  • 00851478007080 ()
DPA-022

  • Blue/red/infrared phototherapy lamp
SUBDURAL GRID ELECTRODE, PLATINUM, 20 CONTACT, 4X5, SMOOTH, INLINE CONNECTOR, 2 EXITS, 2 LEADS, 2 TAILS, #1 CONTACT AT RIGHT CORNER NUMBERED
PMT CORPORATION
2110-20-046
In Commercial Distribution

  • 00650551052838 ()

  • Contact Diameter 3 Millimeter
  • Thickness 0.5 Millimeter
2110-20-046

  • Cortical electrode
SUBDURAL STRIP ELECTRODE, STAINLESS STEEL, 8 CONTACT, 1X8, RADIOPAQUE "L" AT CONTACT #1 & #8, SMOOTH, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2111-08-093
In Commercial Distribution

  • 00650551060932 ()

  • Thickness 0.76 Millimeter
  • Contact Diameter 3 Millimeter
2111-08-093

  • Cortical electrode
SUBDURAL STRIP ELECTRODE, STAINLESS STEEL, 8 CONTACT, 1X8, RADIOPAQUE "L" AT CONTACT #1 & #8, SMOOTH, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2111-08-093-NS
In Commercial Distribution

  • 00650551085508 ()

  • Contact Diameter 3 Millimeter
  • Thickness 0.76 Millimeter
2111-08-093-NS

  • Cortical electrode
SUBDURAL GRID ELECTRODE, PLATINUM, 20 CONTACT, 4X5, SMOOTH, INLINE CONNECTOR, 2 EXITS, 2 LEADS, 2 TAILS, #1 CONTACT AT RIGHT CORNER NUMBERED
PMT CORPORATION
2110-20-046-NS
In Commercial Distribution

  • 00650551077404 ()

  • Thickness 0.5 Millimeter
  • Contact Diameter 3 Millimeter
2110-20-046-NS

  • Cortical electrode
TrackX reusable adapter that enables physicians to more adequately utilize the Insight Base - NV/AT Disc Prep SNAP on their surgical instrument.
TrackX Technology, LLC
TrackX NV INSERT-ADAPT
In Commercial Distribution

  • 00857088008660 ()
TX-3-4089

  • Diagnostic x-ray digital imaging system workstation application software
The Transducer Support Holder provides a rigid, stable post for securing a transducer at the appropriate height for neuro and cardiac surgery.
STERIS CORPORATION
BF263
In Commercial Distribution

  • 00724995182236 ()
BF263

  • Universal operating table top
mccabe flap knife dissector, double-ended, 2.0 mm x 3.0 mm blades angled at 25 degrees & 45 degrees, 7 1/4" (18.5 cm)
NOVO SURGICAL, INC.
E7315-91
In Commercial Distribution

  • 00842331129575 ()
E7315-91

  • Skin grafting knife
fischer tonsil knife & dissector, 15.0 mm curved blade w/ sharp edge at flat tip, top edge serrated, 8 1/2" (21.5 cm)
NOVO SURGICAL, INC.
E8331-81
In Commercial Distribution

  • 00842331140518 ()
E8331-81

  • Skin grafting knife
FIBER OPTIC DEEP PELVIC RETRACTOR WITH DOYAN HANDLE, OVERALL BLADE LENGTH 9" (228MM) X 2.5" (65MM) WIDE AT TOP, 2" (55MM) WIDE
ELMED INCORPORATED
15-09-70F
In Commercial Distribution

  • 00198506081866 ()
15-09-70F

  • Hand-held surgical retractor, reusable
  • Fibreoptic retractor handle
AST Reagent Set for the quantitative determination of Aspartate Aminotransferase (AST) in human serum. Packaged at 5 x 100ml, 2 x 55ml
POINTE SCIENTIFIC, INC.
HA961-610
In Commercial Distribution

  • 00811727012555 ()
HA961-610

  • Aspartate aminotransferase (AST) isoenzyme IVD, reagent
Azar corneal scissors, 4 1/2'', universal medium model, curved 16.0mm blades, blunt tips, calibration markings at 1 to 6.0mm, flat handle
AMBLER SURGICAL CORP.
Azar corneal scissors
In Commercial Distribution

  • 00190660156879 ()
5847E

  • Corneal scissors, reusable
Sideport/Groove economy diamond knife, straight, 1.00mm wide, 45 degrees single edge blade, dull sides, preset at 600 microns, j-slot aluminum handle
AMBLER SURGICAL CORP.
Sideport/Groove economy diamond knife
In Commercial Distribution

  • 00190660211912 ()
21-143E

  • Ophthalmic knife, reusable
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