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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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Ahmed™ ClearPath - 00892064002348

Glaucoma shunt
NEW WORLD MEDICAL, INCORPORATED
250
In Commercial Distribution

  • 00892064002348 ()

  • Area/Surface Area: 250 Square millimeter
CP250

  • Glaucoma shunt, tubular, non-animal-derived

Ahmed Tube Inserter - 00892064002331

Tube Inserter
NEW WORLD MEDICAL, INCORPORATED
TI
Not in Commercial Distribution

  • 00892064002331 ()
TI

  • Ophthalmic implant handling forceps, reusable

Kahook Dual Blade - 00892064002294

Kahook Dual Blade
NEW WORLD MEDICAL, INCORPORATED
KDB
Not in Commercial Distribution

  • 00892064002294 ()
KDB

  • Ophthalmic knife, single-use

Ahmed™ Glaucoma Valve - 00892064002270

Porous Polyethylene Glaucoma Drainage Device
NEW WORLD MEDICAL, INCORPORATED
M4
Not in Commercial Distribution

  • 00892064002270 ()

  • Area/Surface Area: 160 Square millimeter
M4

  • Eye valve

Ahmed™ Glaucoma Valve - 00892064002133

Polypropylene Glaucoma Drainage Device
NEW WORLD MEDICAL, INCORPORATED
S2
Not in Commercial Distribution

  • 00892064002133 ()

  • Area/Surface Area: 184 Square millimeter
S2

  • Eye valve

Ahmed™ Glaucoma Valve - 00892064002126

Glaucoma shunt
NEW WORLD MEDICAL, INCORPORATED
FP8
In Commercial Distribution

  • 00892064002126 ()

  • Area/Surface Area: 102 Square millimeter
FP8

  • Eye valve

Ahmed™ Glaucoma Valve - 00892064002119

Glaucoma shunt
NEW WORLD MEDICAL, INCORPORATED
FP7
In Commercial Distribution

  • 00892064002119 ()

  • Area/Surface Area: 184 Square millimeter
FP7

  • Eye valve

Streamline Surgical System - 00892064002102

Streamline
NEW WORLD MEDICAL, INCORPORATED
10-0066
In Commercial Distribution

  • 00892064002102 ()
10-0066

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use

Ahmed ClearPath ST - 00892064002096

Glaucoma shunt
NEW WORLD MEDICAL, INCORPORATED
ST350
In Commercial Distribution

  • 00892064002096 ()

  • Area/Surface Area: 350 Square millimeter
10-0610

  • Glaucoma shunt, tubular, non-animal-derived

Ahmed ClearPath ST - 00892064002089

Glaucoma shunt
NEW WORLD MEDICAL, INCORPORATED
ST250
In Commercial Distribution

  • 00892064002089 ()

  • Area/Surface Area: 250 Square millimeter
10-0609

  • Glaucoma shunt, tubular, non-animal-derived

Streamline Surgical System - 00892064002072

Streamline
NEW WORLD MEDICAL, INCORPORATED
10-0066
In Commercial Distribution

  • 00892064002072 ()
10-0066

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use

Streamline® Surgical System - 00892064002010

Streamline
NEW WORLD MEDICAL, INCORPORATED
10-0066
Not in Commercial Distribution

  • 00892064002010 ()
10-0066

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use

Kahook Dual Blade Glide - 00892064002003

Kahook Dual Blade Glide
NEW WORLD MEDICAL, INCORPORATED
KDB Glide
In Commercial Distribution

  • 00892064002003 ()
10-0065

  • Ophthalmic knife, single-use

Freshmint - 00085317008642

Freshmint Floss Pick
NEW WORLD IMPORTS, INC.
FLSPK
In Commercial Distribution

  • 00085317008635 ()
  • 00085317008642 ()
  • 00085317008680 ()


  • Dental floss

Freshmint - 00085317007942

Freshmint 12 yd waxed Dental Floss
NEW WORLD IMPORTS, INC.
DF12
In Commercial Distribution

  • 00085317003739 ()
  • 00085317007942 ()
  • 00085317003746 ()


  • Dental floss

Freshmint - 00085317005665

Freshmint® 2 oz Denture Adhesive, Zinc Free, Extra Strength holding power with easy open cap
NEW WORLD IMPORTS, INC.
DA24
In Commercial Distribution

  • 00085317005658 ()
  • 00085317005665 ()
  • 00085317005641 ()


  • Carboxymethylcellulose sodium/polymer denture adhesive, zinc-free

Freshmint - 00085317004064

Freshmint 100 yd waxed Dental Floss
NEW WORLD IMPORTS, INC.
DF100
In Commercial Distribution

  • 00085317007935 ()
  • 00085317004064 ()
  • 00085317004071 ()


  • Dental floss

Freshmint - 00085317003838

Freshmint® 2.4 oz Denture Adhesive, Zinc Free, Extra Strength holding power with easy open cap
NEW WORLD IMPORTS, INC.
DA2
In Commercial Distribution

  • 00085317003852 ()
  • 00085317003838 ()
  • 00085317003845 ()


  • Carboxymethylcellulose sodium/polymer denture adhesive, zinc-free

Freshmint - 00085317003715

Freshmint® 40 ct Denture Cleanser Tablets. Each Tablet Individually wrapped
NEW WORLD IMPORTS, INC.
DENT40
In Commercial Distribution

  • 00085317003708 ()
  • 00085317003715 ()
  • 00085317008697 ()


  • Denture cleanser

Freshmint - 00085317008918

Freshmint Floss Pick 90 Count Bag
NEW WORLD IMPORTS, INC.
Freshmint Floss Pick 90 Count Bag
In Commercial Distribution

  • 00085317008901 ()
  • 00085317008918 ()
  • 00085317008680 ()
FLSPK9036

  • Dental floss

Freshmint - 00085317008116

Freshmint® 100 yards unwaxed, unflavored dental floss
NEW WORLD IMPORTS, INC.
DFUW100
In Commercial Distribution

  • 00085317008109 ()
  • 00085317008116 ()
  • 00085317008093 ()


  • Dental floss

CareALL - 00085317005795

CareALL® .85 oz Denture Adhesive, Zinc Free, Extra Strength holding power with easy open cap
NEW WORLD IMPORTS, INC.
DA85
In Commercial Distribution

  • 00085317005788 ()
  • 00085317005795 ()
  • 00085317005771 ()


  • Carboxymethylcellulose sodium/polymer denture adhesive, zinc-free

Freshmint - 00085317004309

Freshmint® 90 ct Denture Cleanser Tablets. Each Tablet Individually wrapped
NEW WORLD IMPORTS, INC.
DENT90
In Commercial Distribution

  • 00085317004316 ()
  • 00085317004309 ()
  • 00085317008703 ()


  • Denture cleanser

M-Close Kit - 00850009417213

The device is a disposable, ligature passing, suturing apparatus and needle guide for the abdominal wall which is non-powered, hand-held, and hand-manipulated, intended to be used in various general surgical procedures. The device includes a ligature carrier pathway, needle guide, two needles, reference plane T-Bar, and a guidewire. The handle of the device provides two diametrically opposed enclosed guideways for the advancement and retraction of the needles under manual control of a plunger located at the proximal end of the device. As part of the M-Close convenience kit, a Nerve Block Needle is included for the administration of local anesthetic agents to provide regional and local anesthesia. A Telfa Antimicrobial, non-Adherent Pad is provided in the kit for use as a primary dressing for the surgical incision as well as a slip-tip syringe.
New Wave Endo-Surgery Inc.
27-108
In Commercial Distribution

  • 00850009417220 ()
  • 00850009417213 ()
  • 00850009417237 ()
  • 00850009417244 ()

  • Outer Diameter: 12 Millimeter
27-108

  • Suturing unit, single-use

M-Close Kit - 00850009417022

The device is a disposable, ligature passing, suturing apparatus and needle guide for the abdominal wall which is non-powered, hand-held, and hand-manipulated, intended to be used in various general surgical procedures. The device includes a ligature carrier pathway, needle guide, two needles, reference plane T-Bar, and a guidewire. The handle of the device provides two diametrically opposed enclosed guideways for the advancement and retraction of the needles under manual control of a plunger located at the proximal end of the device.As part of the M-Close convenience kit, a Nerve Block Needle is included for the administration of local anesthetic agents to provide regional and local anesthesia. A Telfa Antimicrobial, non-Adherent Pad is also provided in the kit for use as a primary dressing for the surgical incision.
New Wave Endo-Surgery Inc.
27-101
In Commercial Distribution

  • 00850009417053 ()
  • 00850009417022 ()
  • 00850009417060 ()
  • 00850009417107 ()

  • Outer Diameter: 12 Millimeter
27-101

  • Suturing unit, single-use

NEO Modera Pedicle Screw System - 00815730022211

Poly-Axial Screw, Solid, Ø5.5mm x 50mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730022211 ()
3PS55-50-01

  • Bone-screw internal spinal fixation system, non-sterile

NEO Modera Pedicle Screw System - 00815730022198

Poly-Axial Screw, Solid, Ø5.5mm x 40mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730022198 ()
3PS55-40-01

  • Bone-screw internal spinal fixation system, non-sterile

NEO Modera Pedicle Screw System - 00815730022174

Poly-Axial Screw, Solid, Ø5.5mm x 30mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730022174 ()
3PS55-30-01

  • Bone-screw internal spinal fixation system, non-sterile

NEO Modera Pedicle Screw System - 00815730022150

Poly-Axial Screw, Solid, Ø4.5mm x 45mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730022150 ()
3PS45-45-01

  • Bone-screw internal spinal fixation system, non-sterile

NEO Modera Pedicle Screw System - 00815730021924

Mono-Axial Screw, Solid, Ø7.5mm x 40mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730021924 ()
3MS75-40

  • Bone-screw internal spinal fixation system, non-sterile

NEO Modera Pedicle Screw System - 00815730021900

Mono-Axial Screw, Solid, Ø7.5mm x 30mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730021900 ()
3MS75-30

  • Bone-screw internal spinal fixation system, non-sterile

NEO Modera Pedicle Screw System - 00815730021801

Mono-Axial Screw, Solid, Ø5.5mm x 40mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730021801 ()
3MS55-40

  • Bone-screw internal spinal fixation system, non-sterile

NEO Modera Pedicle Screw System - 00815730021740

Mono-Axial Screw, Solid, Ø4.5mm x 30mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730021740 ()
3MS45-30

  • Bone-screw internal spinal fixation system, non-sterile

NEO Modera Pedicle Screw System - 00815730021719

Poly-Axial Screw, Cannulated, Ø8.5mm x 55mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730021719 ()
3PC85-55-01

  • Bone-screw internal spinal fixation system, non-sterile

NEO Modera Pedicle Screw System - 00815730021702

Poly-Axial Screw, Cannulated Ø8.5mm x 50mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730021702 ()
3PC85-50-01

  • Bone-screw internal spinal fixation system, non-sterile

NEO Modera Pedicle Screw System - 00815730021658

Poly-Axial Screw, Cannulated, Ø7.5mm x 55mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730021658 ()
3PC75-55-01

  • Bone-screw internal spinal fixation system, non-sterile

NEO Modera Pedicle Screw System - 00815730021320

Poly-Axial Screw Assembly, Cannulated, Ø6.5mm x 40mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730021320 ()
3PC65-40

  • Bone-screw internal spinal fixation system, non-sterile

NEO Modera Pedicle Screw System - 00815730021313

Poly-Axial Screw Assembly, Cannulated, Ø6.5mm x 35mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730021313 ()
3PC65-35

  • Bone-screw internal spinal fixation system, non-sterile

NEO Modera Pedicle Screw System - 00815730021306

Poly-Axial Screw Assembly, Cannulated, Ø6.5mm x 30mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730021306 ()
3PC65-30

  • Bone-screw internal spinal fixation system, non-sterile

NEO Modera Pedicle Screw System - 00815730021290

Poly-Axial Screw Assembly, Cannulated, Ø5.5mm x 55mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730021290 ()
3PC55-55

  • Bone-screw internal spinal fixation system, non-sterile
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