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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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Glucertain - B492301500

Glucertain Blood Glucose Test Strips, 25/vial, 2 vials/box, 260 boxes/case
CELLERA LLC
30150
In Commercial Distribution

  • B492301500 ()
  • B492301501 ()
  • B492301502 ()
  • B492301503 ()
30150

  • Glucose IVD, kit, electrometry

DIASOL - B467BP4525

Diasol Sodium Bicarbonate Powder
DIASOL, INC.
BP10000- 25G / x25T
In Commercial Distribution

  • B467BP4525 ()
  • B467BP4525G3 ()
  • B467BP4524T2 ()
  • B4674525T1 ()
BP2/3 - BP9/10

  • Haemodialysis concentrate

DRYASOL - B467ACP4522575100

Dryasol Dry Concentrate for Bicarbonate Dialysis
DIASOL, INC.
45225-75100
In Commercial Distribution

  • B467ACP452257510016 ()
  • B467ACP4522575100 ()
  • B467ACP452257510020 ()
  • B467ACP452257510025 ()
ACP8/9/10

  • Haemodialysis concentrate

SPEAX Patch for Home Use - B792FGN010

Patch for use with the SPEAX Digital Communication System for Home Use
ATAIA INC.
FGN-010
In Commercial Distribution

  • B792FGN010 ()
  • B792FGN014 ()
  • B792FGN015 ()
  • B792FGN016 ()
FGN010

  • Voice amplification system

InoMesh - MDLXMAG120300

MAG1-2030: 20cm x 30cm (8in x 12in) Mesh Hernia Mesh Polyvinylidene fluoride/Polybutylene adipate
MEDLINX ACACIA PTE. LTD.
MAG1-2030
In Commercial Distribution

  • MDLXMAG120300 ()
  • MDLXMAG120303 ()
  • MDLXMAG120302 ()
  • MDLXMAG120301 ()
MAG1-2030

  • Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable

InoMesh - MDLXMAG120200

MAG1-2020: 20cm x 20cm (8in x 8in) Mesh Hernia Mesh Polyvinylidene fluoride/Polybutylene adipate
MEDLINX ACACIA PTE. LTD.
MAG1-2020
In Commercial Distribution

  • MDLXMAG120200 ()
  • MDLXMAG120203 ()
  • MDLXMAG120202 ()
  • MDLXMAG120201 ()
MAG1-2020

  • Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable

InoMesh - MDLXMAG115200

MAG1-1520: 15cm x 20cm (6in x 8in) Mesh Hernia Mesh Polyvinylidene fluoride/Polybutylene adipate
MEDLINX ACACIA PTE. LTD.
MAG1-1520
In Commercial Distribution

  • MDLXMAG115200 ()
  • MDLXMAG115203 ()
  • MDLXMAG115202 ()
  • MDLXMAG115201 ()
MAG1-1520

  • Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable

InoMesh - MDLXMAG115150

MAG1-1515: 15cm x 15cm (6in x 6in) Mesh Hernia Mesh Polyvinylidene fluoride/Polybutylene adipate
MEDLINX ACACIA PTE. LTD.
MAG1-1515
In Commercial Distribution

  • MDLXMAG115150 ()
  • MDLXMAG115153 ()
  • MDLXMAG115152 ()
  • MDLXMAG115151 ()
MAG1-1515

  • Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable

InoMesh - MDLXMAG115100

MAG1-1510: 15cm x 10cm (6in x 4in) Mesh Hernia Mesh Polyvinylidene fluoride/Polybutylene adipate
MEDLINX ACACIA PTE. LTD.
MAG1-1510
In Commercial Distribution

  • MDLXMAG115100 ()
  • MDLXMAG115103 ()
  • MDLXMAG115102 ()
  • MDLXMAG115101 ()
MAG1-1510

  • Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable

QuickProfile™ Amphetamine Test Card - M90174014

Immunoassay for the detection of amphetamine in human urine
LUMIQUICK DIAGNOSTICS, INC.
74014
In Commercial Distribution

  • M90174014 ()
  • M901740141 ()
  • M901740143 ()
  • M901740142 ()

  • Length: 75 Millimeter
74014

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

BE 125-1TD Disposable Tee Adapter - M996BE1251TD0

The BE 125-1TD Tee Adapter is intended for use in a ventilator, oxygen or BIPAP circuit. Can be used to easily add a monitoring device such as a temperature probe to the breathing circuit. Dimensions: 22mm O.D. x 22mm I.D. x 15mm I.D. Single Patient Use. Molded of High Density Polyethylene.
INSTRUMENTATION INDUSTRIES, INCORPORATED
BE 125-1TD
In Commercial Distribution

  • M996BE1251TD6 ()
  • M996BE1251TD0 ()
  • M996BE1251TD3 ()
  • M996BE1251TD2 ()
BE 125-1TD

  • Straight/elbow breathing circuit connector, single-use

BE 102 Swivel Tubing Clamp - M996BE1020

Ventilator Tubing Accessory - Swivel Tubing Clamp. Swivels 360 degrees; fits tubing and rails 1/2" to 1" inch diameter.
INSTRUMENTATION INDUSTRIES, INCORPORATED
BE 102
In Commercial Distribution

  • M996BE1026 ()
  • M996BE1020 ()
  • M996BE1025 ()
  • M996BE1023 ()
BE 102

  • Ventilator breathing circuit, single-use

MARK3 - D79690131

Alginate Alternative 380 Fast Set 2/pk. - MARK3®*
CARGUS INTERNATIONAL, INC
9013
In Commercial Distribution

  • D7969013 ()
  • D79690131 ()
  • D79690132 ()
  • D79690133 ()
  • D79690134 ()
9013

  • Silicone dental impression material

MES 9000 Musculoskeletal System - D792N9000M0

Now you can have all of these capabilities in one compact system. Surface EMG, range of motion and muscle testing – may be purchased separately or in any combination. The modular design of the MES 9000 allows you to purchase any combination of modules and expand as your practice grows. The MES 9000 --- the modular system that enables you to do a complete, integrated evaluation with objective documentation that supports your diagnosis.
MYOTRONICS NOROMED, INC
N9000M
In Commercial Distribution

  • D792N91500 ()
  • D792N9000M0 ()
  • D792N92000 ()
  • D792N9200S0 ()


  • Virtual-display rehabilitation system, non-supportive, clinical

MARK3 - D796116110

VPS Putty Fast Set 300ml. each Base & Catalyst - MARK3 EU
CARGUS INTERNATIONAL, INC
1161
In Commercial Distribution

  • D796116110 ()
  • D79611612 ()
  • D79611613 ()
  • D79611614 ()


  • Silicone dental impression material

MARK3 EU - D79611601

VPS Putty Regular Set 300ml. each Base & Catalyst - MARK3 EU
CARGUS INTERNATIONAL, INC
1160
In Commercial Distribution

  • D79611601 ()
  • D79611602 ()
  • D79611603 ()
  • D79611604 ()


  • Silicone dental impression material

MARK3 - D79611531

eXact VPS 380 Impression Material Monophase Regular Set 2/pk. - MARK3®*
CARGUS INTERNATIONAL, INC
1153
In Commercial Distribution

  • D7961153 ()
  • D79611531 ()
  • D79611532 ()
  • D79611533 ()
  • D79611534 ()
1153

  • Silicone dental impression material

Guardian Intraoperative Lead, Medium - B13095250

The Guardian Intraoperative Lead is a single-use, sterile medical device accessory consisting of an electrode for contacting nerve, a lead wire and a connector. The connector securely connects to a Checkpoint intraoperative stimulator to provide electrical stimulation of exposed motor nerves or muscle tissue. The Medium size has lead body width of approximately 7mm.
Checkpoint Surgical, Inc.
9525
In Commercial Distribution

  • B13095251 ()
  • B13095250 ()
  • B13095252 ()
  • B13095253 ()

  • Width: 7 Millimeter
9525

  • Nerve-locating system

AHS - B031AHS2325RN0

NEEDLE,23 X 1
American Health Service Sales Corporation
AHS2325RN
In Commercial Distribution

  • B031AHS2325RN2 ()
  • B031AHS2325RN1 ()
  • B031AHS2325RN0 ()
  • B031AHS2325RN3 ()


  • Hypodermic needle, single-use

SUPARTZ® sodium hyaluronate - M717715655550

SUPARTZ (P980044) is indicated for treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen. SUPARTZ is a sterile, viscoelastic, non-pyrogenic solution (pH of 6.8-7.8) of highly purified, high molecular weight hyaluronic acid (HA) (620 000-1 170 000 daltons). HA, which is extracted from rooster combs, is a polysaccharide containing repeating disaccharide units of glucuronic acid and N-acetylglucosamine. HA is a common constituent of the extracellular matrix of connective tissues. SUPARTZ is supplied sterile in single-use, pre-filled, disposable plastic syringes, each containing 25 mg of HA dissolved in a Phosphate Buffered Saline (PBS) solution (2.5 mL of 1.0% solution).
SEIKAGAKU CORPORATION
89130-5555-01
Not in Commercial Distribution

  • M717715655554 ()
  • M717715655553 ()
  • M717715655552 ()
  • M717715655550 ()
7156-5555

  • Synovial fluid supplementation medium

SUPARTZ FX sodium hyaluronate - M717715644440

SUPARTZ FX (P980044) is indicated for treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen. SUPARTZ FX is a sterile, viscoelastic, non-pyrogenic solution (pH of 6.8-7.8) of highly purified, high molecular weight hyaluronic acid (HA) (620 000-1 170 000 daltons). HA, which is extracted from chicken combs, is a polysaccharide containing repeating disaccharide units of glucuronic acid and N-acetylglucosamine. HA is a common constituent of the extracellular matrix of connective tissues. SUPARTZ FX is supplied sterile in single-use, pre-filled, disposable plastic syringes, each containing 25 mg of HA dissolved in a Phosphate Buffered Saline (PBS) solution (2.5 mL of 1.0% solution).
SEIKAGAKU CORPORATION
89130-4444-1
In Commercial Distribution

  • M717715644440 ()
  • M717715644442 ()
  • M717715644443 ()
  • M717715644444 ()
7156-4444

  • Synovial fluid supplementation medium

Flo2Max Oxygen Mask, Child - B00261100

Flo2Max 5-in-1 Oxygen Mask, Child
B.L.S. Systems Limited
6110
In Commercial Distribution

  • B00266107 ()
  • B00261100 ()
  • B00261109 ()
  • B00261107 ()

  • Child
6110

  • Non-rebreathing oxygen face mask

Stradis Medical, LLC - M752HCT1CCSFST0

1CC SLIP TIP SYRINGES SILICON FREE
STRADIS MEDICAL LLC
HCT1CCSF-ST
In Commercial Distribution

  • M752HCT1CCSFST5 ()
  • M752HCT1CCSFST1 ()
  • M752HCT1CCSFST0 ()
  • M752HCT1CCSFST6 ()


  • General-purpose syringe, single-use

Spetzler - OMT - M731100010

Neuro Pattie; Sterile; X-Ray detectable; Tissue Compatible Rayon; For Single Use.
OMT, LLC
Neuro Patties
In Commercial Distribution

  • M7311100169 ()
  • M731100010 ()
  • M7311100159 ()
  • K900005 ()
  • M7311100189 ()
ALL

  • Cottonoid pad

Cardiva VASCADE MVP VVCS 6-12F - M729800612C0

The VASCADE MVP Venous Vascular Closure System (VVCS) is intended to seal femoral veins with single or multiple access sites in one or both limbs at the completion of catheterization procedures. The system is designed to deliver a resorbable Collagen Patch, extra-vascularly, at vessel puncture sites to achieve hemostasis. For use with 6Fr to 12Fr (15F maximum outer diameter) introducer sheaths; overall length of the sheath (including the hub) needs to be less than 15cm.
CARDIVA MEDICAL, INC.
800-612C
In Commercial Distribution

  • M729800612C2 ()
  • M729800612C0 ()
  • M729800612C1 ()
  • M729800612C3 ()

  • Catheter Gauge: 6 to 12 French


  • Femoral artery closure plug/patch, collagen

Cardiva VASCADE MVP XL VVCS 10-12F - M7298001012XL0

The VASCADE MVP XL Venous Vascular Closure System (VVCS) 10-12F is intended to seal femoral veins with single or multiple access sites in one or both limbs at the completion of catheterization procedures. The system is designed to deliver a resorbable Collagen Patch, extra-vascularly, at vessel puncture sites to achieve hemostasis. For use with 10Fr to 12Fr (15F maximum outer diameter) introducer sheaths; overall length of the sheath (including the hub) needs to be less than 15cm.
CARDIVA MEDICAL, INC.
800-1012XL
In Commercial Distribution

  • M7298001012XL2 ()
  • M7298001012XL0 ()
  • M7298001012XL1 ()
  • M7298001012XL3 ()

  • Catheter Gauge: 10 to 12 French


  • Femoral artery closure plug/patch, collagen

Stradis Medical, LLC. - M752IN90090

Rope And Hook
STRADIS MEDICAL, LLC
IN9009
In Commercial Distribution

  • M752IN90095 ()
  • M752IN90090 ()
  • M752IN90093 ()
  • M752IN90096 ()


  • General surgical procedure kit, non-medicated, single-use

American Red Cross - B268Y78251

ARC Ready For Baby Kit
TOMY INTERNATIONAL, INC.
Y7825
Not in Commercial Distribution

  • B268Y78251 ()
  • B268Y78251 ()
  • B268Y78259 ()
  • B268Y78253 ()
Y7825A1

  • Infant care kit

American Red Cross - B268Y71490

Rectal Thermometer
TOMY INTERNATIONAL, INC.
Y7149
Not in Commercial Distribution

  • B268Y714993 ()
  • B268Y714960 ()
  • B268Y71490 ()
  • B268Y71491 ()


  • General-purpose patient temperature probe, reusable

American Red Cross - B268Y70780

American Red Cross Multi-Use Digital Thermometer
TOMY INTERNATIONAL, INC.
Y7078
Not in Commercial Distribution

  • B268Y707894 ()
  • B268Y70784 ()
  • B268Y70781 ()
  • B268Y70780 ()


  • General-purpose patient temperature probe, reusable

American Red Cross - B268Y7054Y705701

American Red Cross Baby Healthcare Kit
TOMY INTERNATIONAL, INC.
Y7054
Not in Commercial Distribution

  • B268Y70549 ()
  • B268Y70544 ()
  • B268Y70541 ()
  • B268Y7054Y705701 ()
Y7054

  • Infant care kit

American Red Cross - B268Y7054Y70570

Y7057 American Red Cross Healthcare & Grooming Kit (with Thermometer)
TOMY INTERNATIONAL, INC.
Y7054, Y7057
Not in Commercial Distribution

  • B268Y7054Y70579 ()
  • B268Y7054Y70573 ()
  • B268Y7054Y70571 ()
  • B268Y7054Y70570 ()
Y7057

  • Infant care kit

Lamaze - B268Y5288L0

Teether
TOMY INTERNATIONAL, INC.
Y5228L
Not in Commercial Distribution

  • B268Y5288L9 ()
  • B268Y5288L6 ()
  • B268Y5288L1 ()
  • B268Y5288L0 ()


  • Teething device, fluid-filled

The First Years - B268Y52880

Star Teether
TOMY INTERNATIONAL, INC.
Y5288
Not in Commercial Distribution

  • B268Y52880 ()
  • B268Y52281 ()
  • B268Y52886 ()
  • B268Y52889 ()


  • Teething device, fluid-filled

Lamaze - B268L276190

Water Filled Chill Teethers
TOMY INTERNATIONAL, INC.
L27619
Not in Commercial Distribution

  • B268L276198 ()
  • B268L276192 ()
  • B268L276190 ()
  • B268L276199 ()
L27619

  • Teething device, fluid-filled

The First Years - B26879570

Health and Grooming Kit
TOMY INTERNATIONAL, INC.
Y7957
Not in Commercial Distribution

  • B268Y79571 ()
  • B26879570 ()
  • B268Y79573 ()
  • B268Y79579 ()
Y7957

  • Infant care kit

ISEN-Goggles - B499V060

The !SEN-Goggles are used in the assessment of nystagmus by measuring, recording, displaying, and analyzing eye movements. This device consists of patient eye goggles ("ISEN-Goggles"). They have an adjustable, elastic headband, an LCD display, two green LED lights to provide optional focal points, eight infrared LED lights to provide illumination for the internal cameras, an internal SD-type memory, and buttons to operate the device's function. There is also a micro-USS port to facilitate transfer of data captured and stored in the device's SD-type memory. The patient eye goggles are an opaque, facially worn device fitted with two small video cameras, and two wavelengths of light emitting diodes (LEDs). One set of lights provides illumination for the cameras. The other allows the user to provide a focus point for the patient, if this is desired. These signals are processed by the image processor that allows for near-simultaneous viewing of the video images from both eyes on the attached LCD screen.
ISEN Tech. & Trading Co.,Ltd.
V06
In Commercial Distribution

  • B499V062 ()
  • B499V061 ()
  • B499V060 ()


  • Nystagmus inducing optokinetic drum
  • Nystagmus inducing tape

Vitale - B492238440

Vitale Hydrogel Dressing, 4"x4", 1/pouch, 10/box, 10 boxes/case
CELLERA LLC
23844
In Commercial Distribution

  • B492238440 ()
  • B492238441 ()
  • B492238442 ()
23844

  • Wound hydrogel dressing, non-antimicrobial

Vitale - B492238220

Vitale Hydrogel Impregnated Dressing, 2x2, 1/pouch, 10/box, 10 boxes/case
CELLERA LLC
23822
In Commercial Distribution

  • B492238222 ()
  • B492238221 ()
  • B492238220 ()
23822

  • Wound hydrogel dressing, non-antimicrobial

Vitale - B492212900

Vitale Sacral Hydrocolloid Dressing, 6x7, 1/pouch, 10/box, 10 boxes/case
CELLERA LLC
21290
In Commercial Distribution

  • B492212900 ()
  • B492212901 ()
  • B492212902 ()
21290

  • Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial
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