FDA.report

Constellation, Ultravit, TotalPlus, EdgePlus

Primary DI
10380657519009
Brand
Constellation, Ultravit, TotalPlus, EdgePlus
Company
Alcon Laboratories, Inc.
Model
8065751900
Device description
Constellation Vision System 5000 CPM UltraVit Probe Straight Endoilluminator 23 GA TotalPlus Vitrectomy Pak EdgePlus Blade Valved Entry System
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
HQCUnit, phacofragmentation

Product Code Classifications

CodeDeviceSpecialtyClass
HQCUnit, PhacofragmentationOphthalmic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10380657519009PackageGS16In Commercial Distribution
00380657519002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1038065751900910380657519009
00380657519002003806575190023806575190020380657519002

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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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