Double Dilator

GUDID 13760087126072

FCI S A S FCI 20 22

Lacrimal probe, reusable Lacrimal probe, reusable Lacrimal probe, reusable Lacrimal probe, reusable Ophthalmic surgical probe, reusable Ophthalmic surgical probe, reusable Ophthalmic surgical probe, reusable Ophthalmic surgical probe, reusable Ophthalmic surgical probe, reusable Ophthalmic surgical probe, reusable Ophthalmic surgical probe, reusable Ophthalmic surgical probe, reusable Ophthalmic surgical probe, reusable Ophthalmic surgical probe, reusable Ophthalmic surgical probe, reusable Ophthalmic surgical probe, reusable Ophthalmic surgical probe, reusable Ophthalmic surgical probe, reusable Ophthalmic surgical probe, reusable Ophthalmic surgical probe, reusable Ophthalmic surgical probe, reusable
Primary Device ID13760087126072
NIH Device Record Keyf9c3071a-8a29-47d2-9e17-34706aeda272
Commercial Distribution StatusIn Commercial Distribution
Brand NameDouble Dilator
Version Model NumberA8.4050
Company DUNS763408366
Company NameFCI S A S FCI 20 22
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS113760087126072 [Primary]

FDA Product Code

HNWDilator, Lachrymal

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[13760087126072]

Moist Heat or Steam Sterilization


[13760087126072]

Moist Heat or Steam Sterilization


[13760087126072]

Moist Heat or Steam Sterilization


[13760087126072]

Moist Heat or Steam Sterilization


[13760087126072]

Moist Heat or Steam Sterilization


[13760087126072]

Moist Heat or Steam Sterilization


[13760087126072]

Moist Heat or Steam Sterilization


[13760087126072]

Moist Heat or Steam Sterilization


[13760087126072]

Moist Heat or Steam Sterilization


[13760087126072]

Moist Heat or Steam Sterilization


[13760087126072]

Moist Heat or Steam Sterilization


[13760087126072]

Moist Heat or Steam Sterilization


[13760087126072]

Moist Heat or Steam Sterilization


[13760087126072]

Moist Heat or Steam Sterilization


[13760087126072]

Moist Heat or Steam Sterilization


[13760087126072]

Moist Heat or Steam Sterilization


[13760087126072]

Moist Heat or Steam Sterilization


[13760087126072]

Moist Heat or Steam Sterilization


[13760087126072]

Moist Heat or Steam Sterilization


[13760087126072]

Moist Heat or Steam Sterilization


[13760087126072]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-15
Device Publish Date2022-12-07

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13700773735126 - OPHTACATH® 3 mm Bilateral Kit2024-01-05 A collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic
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23700773734775 - TearSaver® - 0.5 mm2023-11-21 Punctum plug
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