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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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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

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

The First Years - B268Y7078A60

Digital Thermometer
TOMY INTERNATIONAL, INC.
Y7078A6
In Commercial Distribution

  • B268Y7078A61 ()
  • B268Y7078A60 ()
  • B268Y7078A64 ()
  • B268Y7078A69 ()


  • General-purpose patient temperature probe, reusable

The First Years - B268Y70510

TFY Rapid Read Underarm Thermometer
TOMY INTERNATIONAL, INC.
Y7051
In Commercial Distribution

  • B268Y70514 ()
  • B268Y70516 ()
  • B268Y70511 ()
  • B268Y70510 ()


  • General-purpose patient temperature probe, reusable

LAMAZE/JOHN DEERE - B268L274120

LAMAZE JD Chill Teether
TOMY INTERNATIONAL, INC.
L27412
In Commercial Distribution

  • B268L274120 ()
  • B268L274122 ()
  • B268L274128 ()
  • B268L274129 ()
L27412

  • Teething device, fluid-filled

BOON - B268B111850

BOON Care Health Kit (Thermometer)
TOMY INTERNATIONAL, INC.
B11185
In Commercial Distribution

  • B268B111859 ()
  • B268B111854 ()
  • B268B111851 ()
  • B268B111850 ()


  • Infant care kit

Environ-mate - B325PT20C101

Polyp Trap with screw top, fine-mesh screen and tube with connector.. Package of 10.
M D Technologies Inc.
PT20C-10
In Commercial Distribution

  • B325PT20C100 ()
  • B325PT20C101 ()
  • B325PT20C252 ()
  • B325PT20C503 ()
  • B325PT20C1004 ()
PT20C10

  • Surgical suction system collection container, single-use

Environ-mate - B325PT20101

Polyp Trap with screw top, fine-mesh screen and plain tube. Package of 10.
M D Technologies Inc.
PT20-10
In Commercial Distribution

  • B325PT20252 ()
  • B325PT20100 ()
  • B325PT20503 ()
  • B325PT201004 ()
  • B325PT20101 ()
PT2010

  • Surgical suction system collection container, single-use

PURE ENRICHMENT - B311PEPADBFLY0

LARGE ELECTRODE PAD
BEAR DOWN CONSULTING
PEPADBFLY
In Commercial Distribution

  • B311PEPADBFLY1 ()
  • B311PEPADBFLY0 ()
  • B311PEPADBFLY2 ()
  • B311PEPADBFLY3 ()


  • Transcutaneous electrical stimulation electrode, single-use

InTray™ GC - B08810800

Intended for use in the qualitative detection of oral, rectal and genitourethral Neisseria gonorrhoeae colonization.
BIO-MED DIAGNOSTICS, INC.
1080
In Commercial Distribution

  • B08810804 ()
  • B08810800 ()
  • B08810802 ()
  • B08810803 ()
10-8000

  • Neisseria gonorrhoeae culture isolate identification IVD, kit

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

S-CRYOLOCK (Y) - B056SCLY1

S-CRYOLOCK - YELLOW - Cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 1-cell stage embryos
BIOTECH INCORPORATED
S-CL (Y)
In Commercial Distribution

  • B056SCLY5 ()
  • B056SCLY2 ()
  • B056SCLY1 ()
  • B056SCLY0 ()
  • B056SCLY3 ()
S-CL (YELLOW)

  • Assisted reproduction vitrification carrier

S-CRYOLOCK (O) - B056SCLO1

S-CRYOLOCK - ORANGE - Cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 1-cell stage embryos
BIOTECH INCORPORATED
S-CL (O)
In Commercial Distribution

  • B056SCLO5 ()
  • B056SCLO2 ()
  • B056SCLO1 ()
  • B056SCLO0 ()
  • B056SCLO3 ()
S-CL (ORANGE)

  • Assisted reproduction vitrification carrier

S-CRYOLOCK (G) - B056SCLG1

S-CRYOLOCK - GREEN - Cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 1-cell stage embryos
BIOTECH INCORPORATED
S-CL (G)
In Commercial Distribution

  • B056SCLG5 ()
  • B056SCLG2 ()
  • B056SCLG1 ()
  • B056SCLG0 ()
  • B056SCLG3 ()
S-CL (GREEN)

  • Assisted reproduction vitrification carrier

S-CRYOLOCK (C) - B056SCLC1

S-CRYOLOCK - CLEAR - Cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 1-cell stage embryos
BIOTECH INCORPORATED
S-CL (C)
In Commercial Distribution

  • B056SCLC5 ()
  • B056SCLC2 ()
  • B056SCLC1 ()
  • B056SCLC0 ()
  • B056SCLC3 ()
S-CL (CLEAR)

  • Assisted reproduction vitrification carrier

S-CRYOLOCK (B) - B056SCLB1

S-CRYOLOCK - BLUE - Cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 1-cell stage embryos
BIOTECH INCORPORATED
S-CL (B)
In Commercial Distribution

  • B056SCLB5 ()
  • B056SCLB2 ()
  • B056SCLB1 ()
  • B056SCLB0 ()
  • B056SCLB3 ()
S-CL (BLUE)

  • Assisted reproduction vitrification carrier

Molded Products, Inc. - B144MPC124R0

Luer Lock Cap - Red
MOLDED PRODUCTS, INC.
MPC-124R
In Commercial Distribution

  • B144MPC124R1 ()
  • B144MPC124R0 ()
  • B144MPC124R2 ()
  • B144MPC124R3 ()
MPC-124R

  • Luer-formatted disinfection cap

Molded Products, Inc. - B144MPC124B0

Luer Lock Cap
MOLDED PRODUCTS, INC.
MPC-124-B
In Commercial Distribution

  • B144MPC124B3 ()
  • B144MPC124B2 ()
  • B144MPC124B1 ()
  • B144MPC124B0 ()
MPC-124-B

  • Luer-formatted disinfection cap

Molded Products, Inc. - B144MPC1150

Female Luer Lock - White - Replacement Cap
MOLDED PRODUCTS, INC.
MPC-115
In Commercial Distribution

  • B144MPC1153 ()
  • B144MPC1152 ()
  • B144MPC1151 ()
  • B144MPC1150 ()
MPC-115

  • Luer-formatted disinfection cap

Molded Products, Inc - B144MPC100S0

Latex-Free Access Site with Luer Slip
MOLDED PRODUCTS, INC.
MPC-100-S
In Commercial Distribution

  • B144MPC100S1 ()
  • B144MPC100S0 ()
  • B144MPC100S2 ()
  • B144MPC100S3 ()
MPC-100-S

  • Luer-formatted disinfection cap

Molded Products, Inc. - B144MPC1000

Intermittent Injection Cap
MOLDED PRODUCTS, INC.
MPC-100
In Commercial Distribution

  • B144MPC1003 ()
  • B144MPC1002 ()
  • B144MPC1001 ()
  • B144MPC1000 ()
MPC-100

  • Catheter injection port

Molded Products, Inc. - B144MPC7450

Collection Assist Device that collects a clean sample from the female hansen port of a hemodialysis machine.
MOLDED PRODUCTS, INC.
MPC-745
In Commercial Distribution

  • B144MPC7451 ()
  • B144MPC7450 ()
  • B144MPC7452 ()
  • B144MPC7453 ()
MPC-745

  • Haemodialysis treatment kit

Molded Products, Inc. - B144MPC1250

Luer Lock Cap Set - (1) Red and (1) Blue per set
MOLDED PRODUCTS, INC.
MPC-125
In Commercial Distribution

  • B144MPC1251 ()
  • B144MPC1250 ()
  • B144MPC1252 ()
  • B144MPC1254 ()
MPC-125

  • Luer-formatted disinfection cap

Molded Products, Inc. - B144MPC1230

Dual End Cap - Male/Female
MOLDED PRODUCTS, INC.
MPC-123
In Commercial Distribution

  • B144MPC1231 ()
  • B144MPC1230 ()
  • B144MPC1232 ()
  • B144MPC1233 ()
MPC-123

  • Luer-formatted disinfection cap
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