Goniotome Handpiece - The Handpiece is a sterile single use ophthalmic - NEOMEDIX CORPORATION

Duns Number:945496792

Device Description: The Handpiece is a sterile single use ophthalmic knife. It consists of a pencil-like instr The Handpiece is a sterile single use ophthalmic knife. It consists of a pencil-like instrument with a graspable white ABS plastic outer shell (~1.5 cm diameter and ~13 cm length), and a stainless steel probe (protruding about 2.2 cm from the tip of the white outer shell and covered by a protective purge chamber). The diameter of the probe insertable into the eye is ~1.1 mm. The tip of the probe features a pointed footplate tip and dual sharpened edges fabricated of stainless steel.The Handpiece is intended to be used in ophthalmic surgery to manually cut Trabecular Meshwork (TM) in adult and infantile patients.

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More Product Details

Catalog Number

550052-15

Brand Name

Goniotome Handpiece

Version/Model Number

550052-15

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

HNN

Product Code Name

Knife, Ophthalmic

Device Record Status

Public Device Record Key

fe9c4643-5e00-476c-9a8a-28728cbf5c03

Public Version Date

July 25, 2019

Public Version Number

1

DI Record Publish Date

July 17, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NEOMEDIX CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4
2 A medical device with a moderate to high risk that requires special controls. 5