Lacrimal probe, reusable - A hand-held, manual, slender rod-like ophthalmic - FCI S A S FCI 20 22

Duns Number:763408366

Device Description: A hand-held, manual, slender rod-like ophthalmic surgical instrument made of flexible meta A hand-held, manual, slender rod-like ophthalmic surgical instrument made of flexible metal, with a blunt bulbous tip, used for exploring the lacrimal canal (the lacrimal duct) during an ophthalmic procedure. This is a reusable device.

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More Product Details

Catalog Number

S1.1460u

Brand Name

Lacrimal probe, reusable

Version/Model Number

RITLENG NASO-LACRIMAL PROBE

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"

-

For Single-Use

-

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

HNL

Product Code Name

Probe, Lachrymal

Device Record Status

Public Device Record Key

c61690c9-14a6-4632-8687-11caaaeb62d6

Public Version Date

March 16, 2020

Public Version Number

1

DI Record Publish Date

March 06, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FCI S A S FCI 20 22" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 82
2 A medical device with a moderate to high risk that requires special controls. 291
U Unclassified 60