FDA.report

Alcon

Primary DI
10380657514486
Brand
Alcon
Company
Alcon Laboratories, Inc.
Model
8065751448
Device description
25 Gauge Entry System, Enhanced, 1 ea
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
HQEInstrument, vitreous aspiration and cutting, ac-powered

Product Code Classifications

CodeDeviceSpecialtyClass
HQEInstrument, Vitreous Aspiration And Cutting, Ac-PoweredOphthalmic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10380657514486PackageGS112In Commercial Distribution
00380657514489PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1038065751448610380657514486
00380657514489003806575144893806575144890380657514489

GMDN Terms

TermDefinition
Ophthalmic cannulation set, single-useA collection of non-powered devices intended to be used to create a channel through the sclera for posterior segment ophthalmic surgery. It consists of metal cannulae, often with tubing, and includes additional ophthalmic instruments/devices intended to support the cannulation procedure (e.g., a trocar, plug, syringe, filter). This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)862-5266web.masterus@alcon.com

Regulatory Flags

DUNS number
008018525
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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00380658544324Clareon TruPlusRECWT3RECWT3.1202026-03-23
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00380658544348Clareon TruPlusRECWT3RECWT3.1302026-03-23
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00380658544362Clareon TruPlusRECWT3RECWT3.1402026-03-23
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00380658544386Clareon TruPlusRECWT3RECWT3.1502026-03-23
00380658544393Clareon TruPlusRECWT3RECWT3.1552026-03-23
00380658544409Clareon TruPlusRECWT3RECWT3.1602026-03-23
00380658544416Clareon TruPlusRECWT3RECWT3.1652026-03-23
00380658544423Clareon TruPlusRECWT3RECWT3.1702026-03-23

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04251954900014Phaco Handpiece Sophi ECOThis AGHQE2026-02-11
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