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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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Simplify - 00843285100993

Simplify Shaft, Internal Assembly Large
Nuvasive, Inc.
CR-JL
In Commercial Distribution

  • 00843285100993 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable

Simplify® Cervical Artificial Disc - 00843285100955

Simplify® Depth Gauge, Size LG
Nuvasive, Inc.
F
In Commercial Distribution

  • 00843285100955 ()
DG-LG

  • Surgical instrument/implant depth limiter, reusable

Simplify® Cervical Artificial Disc - 00843285100948

Simplify® Depth Gauge, Size MD
Nuvasive, Inc.
F
In Commercial Distribution

  • 00843285100948 ()
DG-MD

  • Surgical instrument/implant depth limiter, reusable

Simplify® Cervical Artificial Disc - 00843285100931

Simplify® Depth Gauge, Size SM
Nuvasive, Inc.
F
In Commercial Distribution

  • 00843285100931 ()
DG-SM

  • Surgical instrument/implant depth limiter, reusable

Simplify - 00843285100924

Simplify Adjustable Stop
Nuvasive, Inc.
76243
In Commercial Distribution

  • 00843285100924 ()


  • Surgical depth gauge, reusable

Artificial Iris Fiber Free - 04049154000029

The CustomFlex Artificial Iris is a prosthetic iris (the colored part of the eye around the pupil) made of thin, foldable medical-grade silicone. This device is custom-made and can be sized and colored for each individual patient. This Fiber Free model is suitable for sutureless implant techniques or can be sutured. The CustomFlex Artificial Iris can be used to treat congenital (genetic disorder in which the iris is completely or partially absent) and traumatic aniridia.It can also be used to treat iris defects due to other reasons or conditions, such as albinism, or surgical removal due to melanoma.
HumanOptics AG
95002
In Commercial Distribution

  • 04049154000029 ()

  • Outer Diameter: 12.8 Millimeter
00095002

  • Implantable iris prosthesis

Artificial Iris with Fiber - 04049154000012

The CustomFlex Artificial Iris is a prosthetic iris (the colored part of the eye around the pupil) made of thin, foldable medical-grade silicone. This device is custom-made and can be sized and colored for each individual patient. This with Fiber model has a polyester meshwork layer embedded in it to provide adequate tear strength to withstand suturing. The CustomFlex Artificial Iris can be used to treat congenital (genetic disorder in which the iris is completely or partially absent) and traumatic aniridia.It can also be used to treat iris defects due to other reasons or conditions, such as albinism, or surgical removal due to melanoma.
HumanOptics AG
95001
In Commercial Distribution

  • 04049154000012 ()

  • Outer Diameter: 12.8 Millimeter
00095001

  • Implantable iris prosthesis

SURESTREAM - 10886704072560

Intraspinal Catheter Connector with Strain Relief Sleeve
Medos International Sàrl
70029US
Not in Commercial Distribution

  • 10886704072560 ()
70029US

  • Spinal port/catheter

SURESTREAM - 10886704072553

Intraspinal Catheter Kit A.1 SureStream Catheter;19-gauge;with Guide Wire B.1 Catheter-threading guide C.1 SureStream Connector;titanium D. Anchors 1 each of 4 styles
Medos International Sàrl
70020US
Not in Commercial Distribution

  • 10886704072553 ()
70020US

  • Spinal port/catheter

NA - 10886704067764

Intraspinal Catheter Connector with Strain Relief Sleeve
Medos International Sàrl
60-2950US
Not in Commercial Distribution

  • 10886704067764 ()
602950US

  • Spinal port/catheter
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