FDA.report

Alcon

Primary DI
10380657514462
Brand
Alcon
Company
Alcon Laboratories, Inc.
Model
8065751446
Device description
23 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
10380657514462PackageGS112In Commercial Distribution
00380657514465PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1038065751446210380657514462
00380657514465003806575144653806575144650380657514465

GMDN Terms

TermDefinition
Ophthalmic surgical procedure kit, non-medicated, single-useA collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic surgical procedure; it is not comprised exclusively of dedicated implantation tools and it does not contain any pharmaceuticals. 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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00380658544232Clareon TruPlusRECWT3RECWT3.0752026-03-23
00380658544249Clareon TruPlusRECWT3RECWT3.0802026-03-23
00380658544256Clareon TruPlusRECWT3RECWT3.0852026-03-23
00380658544263Clareon TruPlusRECWT3RECWT3.0902026-03-23
00380658544270Clareon TruPlusRECWT3RECWT3.0952026-03-23
00380658544287Clareon TruPlusRECWT3RECWT3.1002026-03-23
00380658544294Clareon TruPlusRECWT3RECWT3.1052026-03-23
00380658544300Clareon TruPlusRECWT3RECWT3.1102026-03-23
00380658544317Clareon TruPlusRECWT3RECWT3.1152026-03-23
00380658544324Clareon TruPlusRECWT3RECWT3.1202026-03-23
00380658544331Clareon TruPlusRECWT3RECWT3.1252026-03-23
00380658544348Clareon TruPlusRECWT3RECWT3.1302026-03-23
00380658544355Clareon TruPlusRECWT3RECWT3.1352026-03-23
00380658544362Clareon TruPlusRECWT3RECWT3.1402026-03-23
00380658544379Clareon TruPlusRECWT3RECWT3.1452026-03-23
00380658544386Clareon TruPlusRECWT3RECWT3.1502026-03-23
00380658544393Clareon TruPlusRECWT3RECWT3.1552026-03-23
00380658544409Clareon TruPlusRECWT3RECWT3.1602026-03-23

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Primary DIBrandCompanyProduct codePublished
04251954900014Phaco Handpiece Sophi ECOThis AGHQE2026-02-11
10380650003291UNITYAlcon Laboratories, Inc.HQE2025-04-08
10380650003307UNITYAlcon Laboratories, Inc.HQE2025-04-08
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10380650003673UNITYAlcon Laboratories, Inc.HQE2025-04-08
10380650003680UNITYAlcon Laboratories, Inc.HQE2025-04-08
10380650003772UNITYAlcon Laboratories, Inc.HQE2025-04-08
10380650003789UNITYAlcon Laboratories, Inc.HQE2025-04-08
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10380650003840UNITYAlcon Laboratories, Inc.HQE2025-04-08
10380650003857UNITYAlcon Laboratories, Inc.HQE2025-04-08
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20380650004806UNITYAlcon Laboratories, Inc.HQE2025-04-08
20380650004868UNITYAlcon Laboratories, Inc.HQE2025-04-08
20380650004875UNITYAlcon Laboratories, Inc.HQE2025-04-08
20380650005162UNITYAlcon Laboratories, Inc.HQE2025-04-08
20380650005179UNITYAlcon Laboratories, Inc.HQE2025-04-08
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20380650005193UNITYAlcon Laboratories, Inc.HQE2025-04-08
10380650007923UNITYAlcon Laboratories, Inc.HQE2025-04-08
10380650007947UNITYAlcon Laboratories, Inc.HQE2025-04-08
10380650008050UNITYAlcon Laboratories, Inc.HQE2025-04-08
10380650008067UNITYAlcon Laboratories, Inc.HQE2025-04-08
10380650008074UNITYAlcon Laboratories, Inc.HQE2025-04-08