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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No Description
Astar Orthodontics Inc.
1212-014Hm
In Commercial Distribution

  • 86941673501497 ()
  • 06941673501491 ()


  • Orthodontic bracket, metal
No Description
Astar Orthodontics Inc.
1212-013Hd
In Commercial Distribution

  • 86941673501473 ()
  • 06941673501477 ()


  • Orthodontic bracket, metal
ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant).
STERNGOLD DENTAL LLC
812391
In Commercial Distribution

  • 00841549103476 ()


  • Dental implant suprastructure, permanent, preformed
ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant).
STERNGOLD DENTAL LLC
812390
In Commercial Distribution

  • 00841549103469 ()


  • Dental implant suprastructure, permanent, preformed
ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant).
STERNGOLD DENTAL LLC
812389
In Commercial Distribution

  • 00841549103452 ()


  • Dental implant suprastructure, permanent, preformed
ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant).
STERNGOLD DENTAL LLC
812388
In Commercial Distribution

  • 00841549103445 ()


  • Dental implant suprastructure, permanent, preformed
ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant).
STERNGOLD DENTAL LLC
812387
In Commercial Distribution

  • 00841549103438 ()


  • Dental implant suprastructure, permanent, preformed
No Description
Astar Orthodontics Inc.
1212-55-345H
In Commercial Distribution

  • 06973329320095 ()


  • Orthodontic bracket, metal
No Description
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-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
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
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
Isolation Gown, ComPel, Yellow, Raglan Sleeves, Metal Snaps at Neck and Waist, Elastic Sleeve Opening and Thumb Loop
STANDARD TEXTILE CO., INC.
661Y5380
In Commercial Distribution

  • 00634916857535 ()


  • Isolation gown, reusable
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
Tube Holder with 6 slots, Specs on File at Elmed, Surgical Grade Autoclavable Stainless Steel, with Clear Anodizing
ELMED INCORPORATED
ST24SMTHNS6
In Commercial Distribution

  • 00842180199392 ()
ST24SMTHNS6

  • General surgical procedure kit, non-medicated, reusable
Tube Holder with 6 slots, Specs on File at Elmed, Surgical Grade Autoclavable Stainless Steel, with Clear Anodizing
ELMED INCORPORATED
24-SMTHNS-6
In Commercial Distribution

  • 00842180163515 ()
24-SMTHNS-6

  • General surgical procedure kit, non-medicated, reusable
Cooley Miniature Multi Purpose Clamp, jaws calibrated at 5.0 mm intervals, 30 degree angle, 6-1/2" (16.5 cm)
NOVO SURGICAL, INC.
5550-19
Not in Commercial Distribution

  • 00842331116346 ()

  • Length: 16.5 Centimeter
5550-19

  • Surgical soft-tissue manipulation forceps, scissors-like, reusable
Cooley Miniature Multi Purpose Clamp, jaws calibrated at 5.0 mm intervals, 90 degree angle, 5-1/2" (14.0 cm)
NOVO SURGICAL, INC.
5550-17
Not in Commercial Distribution

  • 00842331116322 ()

  • Length: 14 Centimeter
5550-17

  • Surgical soft-tissue manipulation forceps, scissors-like, reusable
Cooley Acutely Curved Clamp, angled shanks, jaws calibrated at 5.0 mm intervals, 6-1/2" (16.5 cm), large jaws
NOVO SURGICAL, INC.
5550-26
Not in Commercial Distribution

  • 00842331116223 ()

  • Length: 16.5 Centimeter
5550-26

  • Surgical soft-tissue manipulation forceps, scissors-like, reusable
Cooley Acutely Curved Clamp, angled shanks, jaws calibrated at 5.0 mm intervals, 6-1/2" (16.5 cm), medium jaws
NOVO SURGICAL, INC.
5550-25
Not in Commercial Distribution

  • 00842331116216 ()

  • Length: 16.5 Centimeter
5550-25

  • Surgical soft-tissue manipulation forceps, scissors-like, reusable
Cooley Acutely Curved Clamp, angled shanks, jaws calibrated at 5.0 mm intervals, 6-1/2" (16.5 cm), small jaws
NOVO SURGICAL, INC.
5550-23
Not in Commercial Distribution

  • 00842331116209 ()

  • Length: 16.5 Centimeter
5550-23

  • Surgical soft-tissue manipulation forceps, scissors-like, reusable
Multimeter with fixed XR Multidetector. The solution for exact dose- and kV-measurements at kV-imager of Proton Therapy Systems.
IBA Dosimetry GmbH
DP0201940
In Commercial Distribution

  • EIBADP02019400 ()
DP0201940

  • Diagnostic x-ray system quality assurance device
Cooley Miniature Multi Purpose Clamp, jaws calibrated at 5.0 mm intervals, 30 degree angle, 6-1/2" (16.5 cm)
NOVO SURGICAL, INC.
C6661-20
In Commercial Distribution

  • 00842331123825 ()


  • Surgical A/V-shaped microvessel clamp
Cooley Miniature Multi Purpose Clamp, jaws calibrated at 5.0 mm intervals, 90 degree angle, 5-1/2" (14.0 cm)
NOVO SURGICAL, INC.
C6661-28
In Commercial Distribution

  • 00842331123801 ()

  • Length: 14 Centimeter


  • Surgical A/V-shaped microvessel clamp
Cooley Acutely Curved Clamp, angled shanks, jaws calibrated at 5.0 mm intervals, 6-1/2" (16.5 cm), large jaws
NOVO SURGICAL, INC.
C6661-37
In Commercial Distribution

  • 00842331123702 ()


  • Surgical A/V-shaped microvessel clamp
Cooley Acutely Curved Clamp, angled shanks, jaws calibrated at 5.0 mm intervals, 6-1/2" (16.5 cm), medium jaws
NOVO SURGICAL, INC.
C6661-36
In Commercial Distribution

  • 00842331123696 ()

  • Length: 16.5 Centimeter


  • Surgical A/V-shaped microvessel clamp
Cooley Acutely Curved Clamp, angled shanks, jaws calibrated at 5.0 mm intervals, 6-1/2" (16.5 cm), small jaws
NOVO SURGICAL, INC.
C6661-34
In Commercial Distribution

  • 00842331123689 ()

  • Length: 16.5 Centimeter


  • Surgical A/V-shaped microvessel clamp
bonaccolto utility forceps, cross-serrated at tip, rear of jaw fluted, 4 1/8" (10.5 cm), 1.7 mm tips
NOVO SURGICAL, INC.
OP7127-89
In Commercial Distribution

  • 00842331164828 ()
OP7127-89

  • Open-surgery biopsy forceps, reusable
Hur Modified Mueller-type Femoral Neck Elevator, 13” Overall Length, 6.5” Handle Length, 1.24” Blade Width at it’s widest
ELMED INCORPORATED
23-3416
In Commercial Distribution

  • 00842180148499 ()
23-3416

  • Orthopaedic surgical procedure kit, non-medicated, reusable
Oesophageal retractor for gastric banding 10mm x 430mm with hole for thread at the tip of the mouth
DEWIMED Medizintechnik GmbH
29-033-760
In Commercial Distribution

  • 04059223112447 ()

  • Outer Diameter: 10 Millimeter
  • Shaft Length: 430 Millimeter


  • Hand-held endoscopic retractor, reusable
ISolate Ready to Use Density Gradient Medium at Two Concentrations. Contains 1x100mL Upper Layer and 1x100mL Lower Layer.
IRVINE SCIENTIFIC, LLC
99264-2x100ML
In Commercial Distribution

  • 00810195240361 ()
99264

  • IVF medium
ISolate Ready to Use Density Gradient Medium at Two Concentrations. Contains 6x6mL Upper Layer and 6x6mL Lower Layer.
IRVINE SCIENTIFIC, LLC
99264-12x6ML
In Commercial Distribution

  • 00810195240354 ()
99264

  • IVF medium
Nagahara Hydrodissection Cannula, 27 Gauge, Gentle angled tip at 35° with vertical flat spatulated tip, 24mm tip length
Diamatrix
C554-35
In Commercial Distribution

  • 00813059015440 ()


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