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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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Integra® Miltex® - 10381780418115

Integra® Miltex® Gill-Hess Iris Forceps, 2-7/8", 1 x 2 Teeth, 0.5mm Wide at Tip
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
18-830
In Commercial Distribution

  • H834188300 ()
  • 10381780418115 ()

  • Width: 0.5 Millimeter
  • 2-7/8"
18-830

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable

Integra® Miltex® - 10381780417873

Integra® Miltex® Eye Dressing Forceps 3-7/8", Standard, Full Curved, Serrated, 0.8mm wide at Tip
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
18-784
In Commercial Distribution

  • H834187840 ()
  • 10381780417873 ()
18-784

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable

Integra® Jarit® - 10381780406143

Integra® Jarit® Gill-Hess Iris Forceps 2-7/8", 1 x 2 Teeth, 0.5mm Wide at Tip
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
X29941
In Commercial Distribution

  • M274X299411 ()
  • 10381780406143 ()
X29941

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable

Colour touch screen T272HLbmjjz 27 Full HD (1080p) 1920 x 1080 at 60 Hz - D800KTAP0273

Colour touch screen T272HLbmjjz 27 Full HD (1080p) 1920 x 1080 at 60 Hz for Zirkonzahn scanner
ZIRKONZAHN SRL
KTAP0273
In Commercial Distribution

  • D800KTAP0273 ()


  • Dental milling system, CAD/CAM, laboratory

MR PHACO - G412CA2700

Lewicky Cortex Extractor 23ga, Curved shaft, .3mm Aspirating Port set at 45 Degree right, 13mm Overall Length
Crestpoint Management Limited
CA270
In Commercial Distribution

  • G412CA2700 ()


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

MR PHACO - G412CA2650

Lewicky Cortex Extractor 23ga, Curved shaft, .3mm Aspirating Port set at 45 Degree left, 13mm Overall Length
Crestpoint Management Limited
CA265
In Commercial Distribution

  • G412CA2650 ()


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

MR PHACO - G412PH1027T0

Colibri Corneal Utility Forceps Very Delicate 1x2 Teeth set at 90 Degree, .12mm, 73mm Overall Length, Titanium
Crestpoint Management Limited
PH1027T
In Commercial Distribution

  • G412PH1027T0 ()


  • Ophthalmic surgical device handling forceps, reusable

Ambler Surgical - 00190660076108

Troutman-Barraquer colibri corneal forceps, 2 7/8'', 0.12mm 1x2 teeth set at 45 degrees, flat handle, titanium
AMBLER SURGICAL CORP.
Troutman-Barraquer colibri corneal forceps
In Commercial Distribution

  • 00190660076108 ()
2240T

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable

Symmetry Austin - 00887482113387

Symmetry® Caliper, Austin Strut, Markers At 3.5 mm, 4 mm & 4.5 mm From Tip, 6 in
SYMMETRY SURGICAL INC.
61-0310
In Commercial Distribution

  • 00887482113387 ()

  • Length: 6 Inch
61-0310

  • General-purpose calliper, metallic

Symmetry Surgical - 00887482155745

Secto® Handle, Laparoscopic, (SGH10 at 20 cm WL), Short, 10 mm, 20.5 cm Working Length, Reusable
SYMMETRY SURGICAL INC.
SGH1032
Not in Commercial Distribution

  • 00887482155745 ()


  • Laparoscopic surgery handle

Knee high boot covers (45g SMS) - 20376885018015

knee high boot covers (45g SMS + SMS Glue Grip dots non skid bottoms, elastic at ankle) [EMS-11211B]
Emergency Medical Solutions LLC
EMS-11211B
In Commercial Distribution

  • 20376885018015 ()
  • 00376885018011 ()


  • Shoe cover

MSI Precision Specialty Instruments - 00194613116965

McCabe Measuring Instrument, Slightly Curved, Round Shaft, Calibrations At 3mm, 4mm, 5m, Overall Length 6-1/8in (156mm)
Med Saver, Inc.
121-23941BX
In Commercial Distribution

  • 00194613116965 ()


  • Medical ruler, reusable

MSI Precision Specialty Instruments - 00194613043001

Cottle Osteotome, Straight, 4mm Wide, Centimeter Marking At 40mm / 50mm / 60mm / 70mm, Overall Length 7-1/4" (184mm)
Med Saver, Inc.
114-5445
In Commercial Distribution

  • 00194613043001 ()


  • Plastic surgery osteotome

RENASYS EDGE - 05000223501143

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

Natus® - 00382830055437

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

Natus® - 00382830056076

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 - 10381780033523

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

Gravity Compensating Accessory - 10381780033516

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

Thino Roth Bracket, .022 Mini, LR5, w/hk at mesial - 06941673501798

No Description
Astar Orthodontics Inc.
1212-045Hm
In Commercial Distribution

  • 86941673501794 ()
  • 06941673501798 ()


  • Orthodontic bracket, metal

Thino Roth Bracket, .022 Mini, LR4, w/hk at distal - 06941673501774

No Description
Astar Orthodontics Inc.
1212-044Hd
In Commercial Distribution

  • 86941673501770 ()
  • 06941673501774 ()


  • Orthodontic bracket, metal

Thino Roth Bracket, .022 Mini, UR3, w/hk at distal - 06941673501569

No Description
Astar Orthodontics Inc.
1212-023Hd
In Commercial Distribution

  • 06941673501569 ()
  • 86941673501565 ()


  • Orthodontic bracket, metal

Thino Roth Bracket, .022 Mini, UL5, w/hk at mesial - 06941673501521

No Description
Astar Orthodontics Inc.
1212-015Hm
In Commercial Distribution

  • 86941673501527 ()
  • 06941673501521 ()


  • Orthodontic bracket, metal

Thino Roth Bracket, .022 Mini, UL4, w/hk at mesial - 06941673501491

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

  • 86941673501497 ()
  • 06941673501491 ()


  • Orthodontic bracket, metal

Thino Roth Bracket, .022 Mini, UL3, w/hk at distal - 06941673501477

No Description
Astar Orthodontics Inc.
1212-013Hd
In Commercial Distribution

  • 86941673501473 ()
  • 06941673501477 ()


  • Orthodontic bracket, metal

Thino Roth Bracket, .022 Mini, LR5, w/hk at distal - 06941673501804

No Description
Astar Orthodontics Inc.
1212-045Hd
In Commercial Distribution

  • 86941673501800 ()
  • 06941673501804 ()


  • Orthodontic bracket, metal

Thino Roth Bracket, .022 Mini, LR4, w/hk at mesial - 06941673501767

No Description
Astar Orthodontics Inc.
1212-044Hm
In Commercial Distribution

  • 86941673501763 ()
  • 06941673501767 ()


  • Orthodontic bracket, metal

Thino Roth Bracket, .022 Mini, LR3, w/hk at distal - 06941673501743

No Description
Astar Orthodontics Inc.
1212-043Hd
In Commercial Distribution

  • 86941673501749 ()
  • 06941673501743 ()


  • Orthodontic bracket, metal

Thino Roth Bracket, .022 Mini, LL5, w/hk at distal - 06941673501712

No Description
Astar Orthodontics Inc.
1212-035Hd
In Commercial Distribution

  • 86941673501718 ()
  • 06941673501712 ()


  • Orthodontic bracket, metal

Thino Roth Bracket, .022 Mini, LL5, w/hk at mesial - 06941673501705

No Description
Astar Orthodontics Inc.
1212-035Hm
In Commercial Distribution

  • 86941673501701 ()
  • 06941673501705 ()


  • Orthodontic bracket, metal

Thino Roth Bracket, .022 Mini, LL4, w/hk at distal - 06941673501682

No Description
Astar Orthodontics Inc.
1212-034Hd
In Commercial Distribution

  • 86941673501688 ()
  • 06941673501682 ()


  • Orthodontic bracket, metal

Thino Roth Bracket, .022 Mini, LL4, w/hk at mesial - 06941673501675

No Description
Astar Orthodontics Inc.
1212-034Hm
In Commercial Distribution

  • 86941673501671 ()
  • 06941673501675 ()


  • Orthodontic bracket, metal

Thino Roth Bracket, .022 Mini, LL3, w/hk at distal - 06941673501651

No Description
Astar Orthodontics Inc.
1212-033Hd
In Commercial Distribution

  • 86941673501657 ()
  • 06941673501651 ()


  • Orthodontic bracket, metal

Thino Roth Bracket, .022 Mini, UR5, w/hk at distal - 06941673501620

No Description
Astar Orthodontics Inc.
1212-025Hd
In Commercial Distribution

  • 86941673501626 ()
  • 06941673501620 ()


  • Orthodontic bracket, metal

Thino Roth Bracket, .022 Mini, UR5, w/hk at mesial - 06941673501613

No Description
Astar Orthodontics Inc.
1212-025Hm
In Commercial Distribution

  • 86941673501619 ()
  • 06941673501613 ()


  • Orthodontic bracket, metal

Thino Roth Bracket, .022 Mini, UR4, w/hk at distal - 06941673501606

No Description
Astar Orthodontics Inc.
1212-025
In Commercial Distribution

  • 86941673501602 ()
  • 06941673501606 ()


  • Orthodontic bracket, metal

Thino Roth Bracket, .022 Mini, UR4, w/hk at distal - 06941673501590

No Description
Astar Orthodontics Inc.
1212-024Hd
In Commercial Distribution

  • 86941673501596 ()
  • 06941673501590 ()


  • Orthodontic bracket, metal

Thino Roth Bracket, .022 Mini, UR4, w/hk at mesial - 06941673501583

No Description
Astar Orthodontics Inc.
1212-024Hm
In Commercial Distribution

  • 86941673501589 ()
  • 06941673501583 ()


  • Orthodontic bracket, metal

Thino Roth Bracket, .022 Mini, UL5, w/hk at distal - 06941673501538

No Description
Astar Orthodontics Inc.
1212-015Hd
In Commercial Distribution

  • 86941673501534 ()
  • 06941673501538 ()


  • Orthodontic bracket, metal

Thino Roth Bracket, .022 Mini, UL4, w/hk at distal - 06941673501507

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

  • 86941673501503 ()
  • 06941673501507 ()


  • Orthodontic bracket, metal

ERA® Implant Abutment Micro Ang. Base, 5mm Cuff (AT) - 00841549103476

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
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