FDA.report

UNITY

Primary DI
10380650004298
Brand
UNITY
Company
Alcon Laboratories, Inc.
Model
00380650004291
Catalog number
8065000429
Device description
22GA Fragmentation Pack
Published
2025-04-08
Public version status
New
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

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
10380650004298PackageGS16In Commercial Distribution
00380650004291PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1038065000429810380650004298
00380650004291003806500042913806500042910380650004291

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.

Sterilization Methods

Method

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
true
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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