LACRIJET® 35 - A collection of devices intended to be used to - FCI S A S FCI 20 22

Duns Number:763408366

Device Description: A collection of devices intended to be used to maintain patency of the nasolacrimal system A collection of devices intended to be used to maintain patency of the nasolacrimal system typically for treating/preventing pathologies of the tear drainage system (e.g., post-chemotherapy stenosis) or after dacryocystorhinostomy (DCR). It consists of a long and flexible bicanalicular or monocanalicular tube (e.g., Crawford type) inserted through the lacrimal puncta into the canaliculi, lacrimal sac, and/or nasolacrimal duct; devices to assist the intubation procedure are typically provided preassembled to the tube (e.g., cannula, probes, bougies, introducer, stylet). The tube is typically left in place long-term before removal. This is a single-use device.

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More Product Details

Catalog Number

-

Brand Name

LACRIJET® 35

Version/Model Number

S1.1535

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

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

OKS

Product Code Name

Lacrimal Stents And Intubation Sets

Device Record Status

Public Device Record Key

90d17c1e-e434-4861-9b72-aa34370f5eb3

Public Version Date

June 07, 2021

Public Version Number

1

DI Record Publish Date

May 30, 2021

Additional Identifiers

Package DI Number

13760087123958

Quantity per Package

1

Contains DI Package

03760087123951

Package Discontinue Date

-

Package Status

In Commercial Distribution

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