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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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STOPCOCK, TMP 4-WAY W/LUER LOCK - B0662010120000

A general-purpose valve that is used to regulate the direction of a liquid or a gas flow. It is typically constructed of a durable material, e.g., plastic and/or metal, and may be used for a variety of general-purpose uses. For stopcocks used in intravenous (IV) lines for injection or removal of fluids see the appropriate GMDN code. This is a single-use device.
NOVOSCI CORP.
201012-000
In Commercial Distribution

  • B0662010120000 ()
  • B0662010120007 ()
  • B0662010120006 ()
  • B0662010120005 ()
  • B0662010120003 ()
201012-000

  • Stopcock

Molded Products, Inc. - B144MPC1500

Male to Male Luer Adapter
MOLDED PRODUCTS, INC.
MPC-150
In Commercial Distribution

  • B144MPC1503 ()
  • B144MPC1502 ()
  • B144MPC1501 ()
  • B144MPC1500 ()
  • B144MPC1504 ()
MPC-150

  • Haemodialysis blood tubing set, single-use

Molded Products, Inc. - B144MPC125Y0

Luer Lock Cap
MOLDED PRODUCTS, INC.
MPC-125Y
In Commercial Distribution

  • B144MPC125Y3 ()
  • B144MPC125Y2 ()
  • B144MPC125Y1 ()
  • B144MPC125Y0 ()
  • B144MPC125Y4 ()
MPC-125Y

  • Luer-formatted disinfection cap

Molded Products, Inc. - B144MPC125R0

Luer Lock Cap
MOLDED PRODUCTS, INC.
MPC-125R
In Commercial Distribution

  • B144MPC125R3 ()
  • B144MPC125R2 ()
  • B144MPC125R1 ()
  • B144MPC125R0 ()
  • B144MPC125R4 ()
MPC-125R

  • Luer-formatted disinfection cap

Molded Products, Inc. - B144MPC125B0

Luer Lock Cap
MOLDED PRODUCTS, INC.
MPC-125B
In Commercial Distribution

  • B144MPC125B3 ()
  • B144MPC125B2 ()
  • B144MPC125B1 ()
  • B144MPC125B0 ()
  • B144MPC125B4 ()
MPC-125B

  • Luer-formatted disinfection cap

Easy Glide 20cc Luer Lock Syringe - B2086720200

Easy Glide 20cc Luer Lock Syringe
GLOBAL DIABETIC DISTRIBUTORS INC
672020
In Commercial Distribution

  • B2086720203 ()
  • B2086720201 ()
  • B2086720200 ()
  • B2086720204 ()
  • B2086720205 ()


  • General-purpose syringe, single-use

Clear Guide SteriGRID - B201CGSG0

The device is a needle guide grid for image-guided transperineal procedures. The device is intended to guide needle placements during endorectal ultrasound and MR/CT-guided interventions. The device is intended for use in a clinical setting. The device is intended as a disposable accessory to Clear Guide TP Access Tool (CG-PAT)
CLEAR GUIDE MEDICAL, INC.
CGSG
In Commercial Distribution

  • B201CGSG0 ()
  • B201CGSG1 ()
  • B201CGSG2 ()
  • B201CGSG3 ()
  • B201CGSG4 ()

  • Needle Gauge: 14 Gauge
CG-SG

  • Needle guide, single-use

MRIaudio Ear-Tip - B6693020

Biocompatible MRIaudio disposable ear-tip certified to 29dB NRR.
MRIAUDIO, INC.
302
In Commercial Distribution

  • B6693020 ()
  • B6693501 ()
  • B6693251 ()
  • B6693011 ()
  • B6693001 ()
302

  • Headphones

StaClear - B994SC250AN0

The StaClear® Syringe is a single-use piston syringe consisting of a 0.25 mL graduated barrel, plunger, plunger gasket, needle, needle cap, and plunger cap. It is non-toxic, non-pyrogenic, and sterilized by ethylene oxide gas. The StaClear® Syringe is suitable for ophthalmic use.
Staclear, Inc.
SC250AN
In Commercial Distribution

  • B994SC250AN0 ()
  • B994SC250AN2 ()
  • B994SC250AN6 ()
  • B994SC250AN8 ()
  • B994SC250AN4 ()

  • Total Volume: 0.25 Milliliter
  • Needle Gauge: 31 Gauge
  • Length: 8 Millimeter
SC250AN

  • General-purpose syringe/needle

StaClear - B994SC2500

The StaClear® Syringe is a single-use piston syringe consisting of a 0.25 mL graduated barrel, plunger, plunger gasket, needle, needle cap, and plunger cap. It is non-toxic, non-pyrogenic, and sterilized by ethylene oxide gas. The StaClear® Syringe is suitable for ophthalmic use.
Staclear, Inc.
SC250
Not in Commercial Distribution

  • B994SC2501 ()
  • B994SC2500 ()
  • B994SC2503 ()
  • B994SC2505 ()
  • B994SC2502 ()

  • Total Volume: 0.25 Milliliter
  • Needle Gauge: 31 Gauge
  • Length: 8 Millimeter
SC250

  • General-purpose syringe/needle

Phosphor Storage Plate IDX S2 - E247G36120

No Description
DÜRR DENTAL SE
G3612
In Commercial Distribution

  • E247G36221 ()
  • E247G36120 ()
  • E247G36311 ()
  • E247G36321 ()
  • E247G36331 ()


  • Digital imaging phosphor plate, dental, intraoral

ScanX Intraoral for Centralized Imaging - D678F36050

ScanX Intraoral for Centralized Imaging is a device that scans photostimulable phosphor plates that have been exposed in the place of dental x-ray film and allows those images to be displayed on a CRT and stored for later recovery in a computer memory. It will be used by dentists and authorized dental auxiliary personnel for this purpose.
AIR TECHNIQUES, INC.
F3605
In Commercial Distribution

  • D678F36050 ()
  • D678F36001 ()
  • D678F3600U1 ()
  • D678F36051 ()
  • D678F3600C1 ()

  • Height: 16 Inch
  • Depth: 15.5 Inch
  • Width: 15.5 Inch
  • Weight: 44 Pound
F3600

  • Radiography digital imaging scanner

Vitale - B492202670

Vitale Silicone Super-Absorbent Dressings, 6" x 7", 10/box, 10 boxes/case, 2 cases/overpack
CELLERA LLC
20267
Not in Commercial Distribution

  • B492202673 ()
  • B492202671 ()
  • B492202670 ()
  • B492202672 ()
  • B49220673 ()
20267

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

Megatray - EMD11MYDVOKS2

Light curing composite for the production of individual impression trays and base plates
MEGADENTA Dentalprodukte GmbH
2022/11/05
In Commercial Distribution

  • EMD11MYDVOKRS1 ()
  • EMD11MYDVOKS2 ()
  • EMD11MYDVOKBL1 ()
  • EMD11MYDVOKTR1 ()
  • EMD11MYDVOKRS11 ()


  • Dental impression tray material

ORTHOSOURCE - D9115670410

Blue Etch 1.2 cc syringe
ORTHOSOURCE
567-041
In Commercial Distribution

  • D911557041503 ()
  • D9115670410 ()
  • D911567041202 ()
  • D91156704141 ()


  • Dental etching solution

ORTHOSOURCE - D9115670400

Red Etch 1.2 cc syringe
ORTHOSOURCE
567-040
In Commercial Distribution

  • D911557040503 ()
  • D9115670400 ()
  • D911567040202 ()
  • D91156704041 ()


  • Dental etching solution

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

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

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

American Red Cross - B268Y78251

ARC Ready For Baby Kit
TOMY INTERNATIONAL, INC.
Y7825
In Commercial Distribution

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

  • Infant care kit

American Red Cross - B268Y71490

Rectal Thermometer
TOMY INTERNATIONAL, INC.
Y7149
In Commercial Distribution

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


  • General-purpose patient temperature probe, reusable

The First Years - B268Y7078A70

Multi-Use Digital Thermometer
TOMY INTERNATIONAL, INC.
Y7078A7
In Commercial Distribution

  • B268Y7078A71 ()
  • B268Y7078A70 ()
  • B268Y7078A74 ()
  • B268Y7078A76 ()
Y7078A7

  • General-purpose patient temperature probe, reusable
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