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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Astar Orthodontics Inc.
1212-55-3H
In Commercial Distribution

  • 06973329320088 ()


  • Orthodontic bracket, metal
RENASYS EDGE Carry Straps
SMITH & NEPHEW MEDICAL LIMITED
66803137
In Commercial Distribution

  • 05000223501150 ()
  • 05000223501143 ()

  • 42x135x12 milimeter W x H x D (approximate dimensions with strap at longest)
66803137

  • Negative-pressure wound therapy system, electric, reusable
Gravity Compensating Accessory, Low Pressure Range (White)
NATUS MEDICAL INCORPORATED
NT903430
In Commercial Distribution


  • Additional Resistance to Flow at 5ml/h, Horizontal Orientation < 30mmH2O, Vertical Orientation: 140-170mmH2O
NT903430

  • Ventriculo-peritoneal/atrial shunt
Gravity Compensating Accessory, Medium Pressure Range (Yellow)
NATUS MEDICAL INCORPORATED
NT903435
In Commercial Distribution


  • Additional Resistance to Flow at 5ml/h, Horizontal Orientation < 30mmH2O, Vertical Orientation: 200-250mmH2O
NT903435

  • Ventriculo-peritoneal/atrial shunt
The Gravity Compensating Accessory (GCA) is designed to counterbalance gravity’s effects on the fluid column within the drainage catheter of an implanted shunt system. The GCA consists of a silicone elastomer encased stainless steel housing with a ruby ball held in a stainless steel seat (in the vertical orientation) by two to four stainless steel balls. In the horizontal orientation, a minimal resistance to flow (<30mmH2O at 5ml/h) is added to the system, and in the vertical orientation: 140-170, 200-250 or 260-320mmH2O (at 5ml/h).
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
903435
Not in Commercial Distribution

  • 10381780033523 ()
  • M2729034351 ()

  • Additional Resistance to Flow at 5ml/h, Horizontal Orientation < 30mmH2O, Vertical Orientation: 200-250mmH2O
903435

  • Ventriculo-peritoneal/atrial shunt
The Gravity Compensating Accessory (GCA) is designed to counterbalance gravity’s effects on the fluid column within the drainage catheter of an implanted shunt system. The GCA consists of a silicone elastomer encased stainless steel housing with a ruby ball held in a stainless steel seat (in the vertical orientation) by two to four stainless steel balls. In the horizontal orientation, a minimal resistance to flow (<30mmH2O at 5ml/h) is added to the system, and in the vertical orientation: 140-170, 200-250 or 260-320mmH2O (at 5ml/h).
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
903430
Not in Commercial Distribution

  • 10381780033516 ()
  • M2729034301 ()

  • Additional Resistance to Flow at 5ml/h, Horizontal Orientation < 30mmH2O, Vertical Orientation: 140-170mmH2O
903430

  • Ventriculo-peritoneal/atrial shunt
The sterile, single use Flo-Thru Intraluminal Shunt is a one-piece radiopaque silicone tube with atraumatic bulbs shaped at each end. Openings at the ends of the bulbs allow blood to flow through the shunt and distal to the anastomosis.
SYNOVIS LIFE TECHNOLOGIES, INC.
FT-12300
In Commercial Distribution

  • 50085412532511 ()
  • 00085412532516 ()
FT12300

  • Surgical intravascular shunt
The sterile, single use Flo-Thru Intraluminal Shunt is a one-piece radiopaque silicone tube with atraumatic bulbs shaped at each end. Openings at the ends of the bulbs allow blood to flow through the shunt and distal to the anastomosis.
SYNOVIS LIFE TECHNOLOGIES, INC.
FT-12275
In Commercial Distribution

  • 50085412532504 ()
  • 00085412532509 ()
FT12275

  • Surgical intravascular shunt
The sterile, single use Flo-Thru Intraluminal Shunt is a one-piece radiopaque silicone tube with atraumatic bulbs shaped at each end. Openings at the ends of the bulbs allow blood to flow through the shunt and distal to the anastomosis.
SYNOVIS LIFE TECHNOLOGIES, INC.
FT-12250
In Commercial Distribution

  • 50085412532498 ()
  • 00085412532493 ()
FT12250

  • Surgical intravascular shunt
The sterile, single use Flo-Thru Intraluminal Shunt is a one-piece radiopaque silicone tube with atraumatic bulbs shaped at each end. Openings at the ends of the bulbs allow blood to flow through the shunt and distal to the anastomosis.
SYNOVIS LIFE TECHNOLOGIES, INC.
FT-12225
In Commercial Distribution

  • 50085412532481 ()
  • 00085412532486 ()
FT12225

  • Surgical intravascular shunt
The sterile, single use Flo-Thru Intraluminal Shunt is a one-piece radiopaque silicone tube with atraumatic bulbs shaped at each end. Openings at the ends of the bulbs allow blood to flow through the shunt and distal to the anastomosis.
SYNOVIS LIFE TECHNOLOGIES, INC.
FT-12200
In Commercial Distribution

  • 50085412532474 ()
  • 00085412532479 ()
FT12200

  • Surgical intravascular shunt
The sterile, single use Flo-Thru Intraluminal Shunt is a one-piece radiopaque silicone tube with atraumatic bulbs shaped at each end. Openings at the ends of the bulbs allow blood to flow through the shunt and distal to the anastomosis.
SYNOVIS LIFE TECHNOLOGIES, INC.
FT-12175
In Commercial Distribution

  • 50085412532467 ()
  • 00085412532462 ()
FT12175

  • Surgical intravascular shunt
The sterile, single use Flo-Thru Intraluminal Shunt is a one-piece radiopaque silicone tube with atraumatic bulbs shaped at each end. Openings at the ends of the bulbs allow blood to flow through the shunt and distal to the anastomosis.
SYNOVIS LIFE TECHNOLOGIES, INC.
FT-12150
In Commercial Distribution

  • 50085412532450 ()
  • 00085412532455 ()
FT12150

  • Surgical intravascular shunt
The sterile, single use Flo-Thru Intraluminal Shunt is a one-piece radiopaque silicone tube with atraumatic bulbs shaped at each end. Openings at the ends of the bulbs allow blood to flow through the shunt and distal to the anastomosis.
SYNOVIS LIFE TECHNOLOGIES, INC.
FT-12125
In Commercial Distribution

  • 50085412532443 ()
  • 00085412532448 ()
FT12125

  • Surgical intravascular shunt
The sterile, single use Flo-Thru Intraluminal Shunt is a one-piece radiopaque silicone tube with atraumatic bulbs shaped at each end. Openings at the ends of the bulbs allow blood to flow through the shunt and distal to the anastomosis.
SYNOVIS LIFE TECHNOLOGIES, INC.
FT-12100
In Commercial Distribution

  • 50085412532436 ()
  • 00085412532431 ()
FT12100

  • Surgical intravascular shunt
VRT-or Vision Restoration Therapy- is a computer-based light stimulation therapy that can be performed at the patient's home.
Novavision, Inc.
VRT 7.0
In Commercial Distribution

  • 00860010599709 ()


  • Vision training software
Portable, battery powered laser therapy device emitting up to 1W at 635/405nm in CW or pulsed modes.
AVANT WELLNESS SYSTEMS INC.
LZ30 Revi-Vet
In Commercial Distribution

  • 00852116008124 ()


  • Musculoskeletal/physical therapy laser, professional
Portable, battery powered laser therapy device emitting up to 1W at 635/405nm in CW or pulsed modes.
AVANT WELLNESS SYSTEMS INC.
LZ30 Revi-Home
In Commercial Distribution

  • 00852116008117 ()


  • Musculoskeletal/physical therapy laser, professional
Portable, battery powered laser therapy device emitting up to 1.5W at 635/808nm in CW or pulsed modes.
AVANT WELLNESS SYSTEMS INC.
LZ30 ProZ-Vet
In Commercial Distribution

  • 00852116008100 ()


  • Musculoskeletal/physical therapy laser, professional
Portable, battery powered laser therapy device emitting up to 1W at 635/808nm in CW or pulsed modes.
AVANT WELLNESS SYSTEMS INC.
LZ30 Z-Home
In Commercial Distribution

  • 00852116008094 ()


  • Musculoskeletal/physical therapy laser, professional
Suction device composed of a surgical cannula pre-installed at the end of the PVC aspirator tube of 2.70m
HYGITECH
HY-12017
In Commercial Distribution

  • 03615140001885 ()
  • 03615140001878 ()
  • 03615140001892 ()
HY-12017

  • Airway suction catheter
Tidal Volume Range(250-1500mL), Media(Foam), Dead Space(38mL), Breathing Resistance(2.5cm H2O at 60L /min) Weight(9g)
Dynarex Corporation
30201
In Commercial Distribution

  • 00840117305427 ()
  • 00840117305410 ()


  • Heat/moisture exchanger/microbial medical gas filter
Vitreoretinal End Gripping Forceps With Extended Gripping Area At the End Of The Tip, 20 Ga, Tip Only
RUMEX INTERNATIONAL CORP.
12-401
In Commercial Distribution

  • 00840159907016 ()
12-401

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
Harms colibri forceps, 3'', very delicate 0.12mm, 1x2 teeth set at 45 degrees, 6.0mm tying platform, flat handle
AMBLER SURGICAL CORP.
Harms colibri forceps
In Commercial Distribution

  • 00190660055622 ()
2235E

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
End Gripping Vitreoretinal Forceps With Extended Gripping Area At The End Of The Tip, 23 Ga, Tip Only
RUMEX INTERNATIONAL CORP.
12-4012
In Commercial Distribution

  • 00840159902554 ()
12-4012

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
FISHER Tonsil Knife and Dissector, 15mm curved blade with sharp edge at flat tip, top edge serrated, 9"
BR Surgical, LLC
BR50-17122
In Commercial Distribution

  • 00840183512484 ()
BR50-17122

  • Tonsil dissector, reusable
Integra® Miltex® Cleveland Oral Surgery Rongeur 5-1/4", No. 5S, Side Cutting, Jaws at 30° Angle
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
22D-428
In Commercial Distribution

  • H83422D4280 ()
  • 10381780424864 ()
22D-428

  • Dental rongeur
Integra® Miltex® Cleveland Oral Surgery Rongeur 6-1/2", No. 5A, Side Cutting, Jaws at 25° Angle
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
22D-426
In Commercial Distribution

  • H83422D4260 ()
  • 10381780424857 ()
22D-426

  • Dental rongeur
Integra® Miltex® Cleveland Oral Surgery Rongeur 6-1/2", No. 5, Side Cutting, Jaws at 25° Angle
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
22-490
In Commercial Distribution

  • H834224900 ()
  • 10381780424703 ()
22-490

  • Dental rongeur
Integra® Miltex® Lester Fixation Forceps 3-7/8", Delicate, 2 x 3 Teeth, 1.1mm Wide at Tip
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
18-914
In Commercial Distribution

  • H834189140 ()
  • 10381780418375 ()

  • Width: 1.1 Millimeter
  • 3-7/8"
18-914

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
Integra® Miltex® Bishop-Harmon Tissue Forceps 3-3/8", Standard, 1 x 2 Teeth, 0.6mm wide at Tip
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
18-868
In Commercial Distribution

  • H834188680 ()
  • 10381780418252 ()

  • 3-3/8"
  • Width: 0.6 Millimeter
  • 1 x 2 Teeth
18-868

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
Integra® Miltex® Iris Tissue Forceps 4", Standard, Straight, 1 x 2 Teeth, 0.8mm wide at Tip
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
18-786
In Commercial Distribution

  • H834187860 ()
  • 10381780417897 ()
18-786

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
Integra® Miltex® Lester Fixation Forceps, 3-7/8", Delicate, 1 x 2 Teeth, 0.55mm Wide at Tip
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
18-912
In Commercial Distribution

  • H834189120 ()
  • 10381780418368 ()

  • Width: 0.55 Millimeter
  • 3-7/8"
18-912

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
Integra® Miltex® O'Brien Fixation Forceps, 4", 1 x 2 Teeth, Angled Forward, 0.75mm Wide at Tip
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
18-904
In Commercial Distribution

  • H834189040 ()
  • 10381780418344 ()

  • Length: 4 Inch
  • Width: 0.75 Millimeter
18-904

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
Integra® Miltex® Depth Gauge, Ball Tip, Marks at 7, 8, 10, 13, 15, 18 and 20mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
62-170
In Commercial Distribution

  • H834621700 ()
  • 10381780495208 ()
62-170

  • Interproximal dental gauge, reusable
Integra® Jarit® Cleveland Oral Surgery Rongeur 5-1/4", No. 5S, Side Cutting, Jaws at 30° Angle
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
X33E539
In Commercial Distribution

  • M274X33E5391 ()
  • 10381780407867 ()
X33E539

  • Dental rongeur
Integra® Jarit® Cleveland Oral Surgery Rongeur 6-1/2", No. 5A, Side Cutting, Jaws at 25° Angle
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
X33E537
In Commercial Distribution

  • M274X33E5371 ()
  • 10381780407850 ()
X33E537

  • Dental rongeur
Instrument used to place the cap of the WasherCap™ Fixation System at the entrance of the tunnel.
ABANZA TECNOMED SL.
21
In Commercial Distribution

  • 08437019739508 ()
  • 28437019739502 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
Instrument used to place the cap of the WasherCap™ Fixation System at the entrance of the tunnel.
ABANZA TECNOMED SL.
21
In Commercial Distribution

  • 08437019739485 ()
  • 28437019739489 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
Rubman-Bores corneal fixation forceps, 4 1/4'', angled shafts, u-shaped, 3.0mm spread, 0.12mm 1x2 teeth at each tip
AMBLER SURGICAL CORP.
Rubman-Bores corneal fixation forceps
In Commercial Distribution

  • 00190660072285 ()
9570E

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
Utrata Capsulorrhexis Forceps, With Cystotome Tips With Marks at 2.5 &5.0mm, Flat Handle, 11.5mm Angled Shaft, Titanium, 85mm
AURORA SURGICAL, LLC
AS7-1021T
In Commercial Distribution

  • 08175700122962 ()
AS7-1021T

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
Inamura Capsulorrhexis Fcps, Corneal Incision, 1.5mm, 8.5mm Jaws Marks Cross Action, Flat Handle, Marked at 2.5mm and 5mm
AURORA SURGICAL, LLC
AS7-132T
In Commercial Distribution

  • 08175700122931 ()
AS7-132T

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
Capsulorrhexis Forceps, Kawai Type, Cystotome Tip Serrated Grove, Incremental Marks at 2.5, 5.0 &7.5mm, 23g Titanium Squeeze Handle
AURORA SURGICAL, LLC
AS7-124T
In Commercial Distribution

  • 08175700122917 ()
AS7-124T

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
Troutman-Barraquer Colibri Corneal Utility Forceps Very Delicate 1x2 Teeth set at 45 Degree, .12mm, 73mm Overall Length, Titanium
Crestpoint Management Limited
PH2242T
In Commercial Distribution

  • G412PH2242T0 ()


  • Ophthalmic surgical device handling forceps, reusable
Colibri Corneal Utility Forceps Very Delicate 1x2 Teeth set at 90 Degree, .12mm, 73mm Overall Length, Stainless Steel
Crestpoint Management Limited
PH1027
In Commercial Distribution

  • G412PH10270 ()


  • Ophthalmic surgical device handling forceps, reusable
Colibri Corneal Utility Forceps Very Delicate 1x2 Teeth set at 90 Degree, .12mm, 73mm Overall Length, Stainless Steel
Crestpoint Management Limited
PH1027
Not in Commercial Distribution

  • G412PH1027 ()


  • Ophthalmic surgical device handling forceps, reusable
Maumenee Viteous Aspirating Needle 18ga Markings on shaft at 10mm 15mm and 20mm from tip, 25mm Overall Length
Crestpoint Management Limited
CA1304
In Commercial Distribution

  • G412CA13040 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
Scalp Elevator "S" Shaped 24cm Ergo Hdl., Bent 10" at hdl., qtr. cvd 12.5mm BL w/ beveled edges
ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION
ASSI.AEP112726E
In Commercial Distribution

  • 00841645124887 ()


  • Bone lever/elevator, reusable
kVue CT Base for GE Lightspeed VCT Scanner For 262 cm long cradle, requires at least 1 insert
Qfix
RT-4550KVGEC
In Commercial Distribution

  • 10841962108918 ()

  • Length: 262 Centimeter
RT-4550KVGEC

  • Indexed-immobilization patient positioning system
Elvarex 1/Thigh High/Profile-Slant-Open Toe/Thigh high slip form without volant to sew at body bandage/Cocoa
BSN-Jobst GmbH
77310-01381-00
In Commercial Distribution

  • 04019702536072 ()

  • Pressure: 18-21 mmHg


  • Compression/pressure sock/stocking, reusable
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