FDA.reportPublic FDA data

CONSTELLATION® HYPERVIT® TOTAL PLUS®

Primary DI
00380658300777
Brand
CONSTELLATION® HYPERVIT® TOTAL PLUS®
Company
Alcon Laboratories, Inc.
Model
8065830077
Device description
25+®Ga HYPERVIT® Bevel 20K CPM Wide TOTAL PLUS® Vitrectomy Pak
Published
2020-12-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MLZVitrectomy, instrument cutter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MLZVitrectomy, Instrument CutterOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10380658300774PackageGS16In Commercial Distribution
00380658300777PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038065830077410380658300774
00380658300777003806583007773806583007770380658300777

GMDN Terms#

Term, Definition table
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.

Regulatory Flags#

DUNS number
008018525
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00380658454418Clareon VivityCNWET4CNWET4-0602026-09-04
00380658454425Clareon VivityCNWET4CNWET4-0652026-09-04
00380658454432Clareon VivityCNWET4CNWET4-0702026-09-04
00380658454449Clareon VivityCNWET4CNWET4-0752026-09-04
00380658454456Clareon VivityCNWET4CNWET4-0802026-09-04
00380658454463Clareon VivityCNWET4CNWET4-0852026-09-04
00380658454470Clareon VivityCNWET4CNWET4-0902026-09-04
00380658454487Clareon VivityCNWET4CNWET4-0952026-09-04
00380658454494Clareon VivityCNWET4CNWET4-1002026-09-04
00380658454500Clareon VivityCNWET4CNWET4-1052026-09-04
00380658454517Clareon VivityCNWET4CNWET4-1102026-09-04
00380658454524Clareon VivityCNWET4CNWET4-1152026-09-04
00380658454531Clareon VivityCNWET4CNWET4-1202026-09-04
00380658454548Clareon VivityCNWET4CNWET4-1252026-09-04
00380658454555Clareon VivityCNWET4CNWET4-1302026-09-04
00380658454562Clareon VivityCNWET4CNWET4-1352026-09-04
00380658454579Clareon VivityCNWET4CNWET4-1402026-09-04
00380658454586Clareon VivityCNWET4CNWET4-1452026-09-04
00380658454593Clareon VivityCNWET4CNWET4-1502026-09-04
00380658454609Clareon VivityCNWET4CNWET4-1552026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850005541080MICOR Auto I/ACarl Zeiss Meditec, Cataract Technology, Inc.MLZ2025-08-19
00380650000187UNITYAlcon Laboratories, Inc.MLZ2025-04-08
00380657531745UNITYAlcon Laboratories, Inc.MLZ2025-04-08
00380657531776UNITYAlcon Laboratories, Inc.MLZ2025-04-08
10380650000184UNITYAlcon Laboratories, Inc.MLZ2025-04-08
10380657531742UNITYAlcon Laboratories, Inc.MLZ2025-04-08
10380657531773UNITYAlcon Laboratories, Inc.MLZ2025-04-08
00380657531752UNITYAlcon Laboratories, Inc.MLZ2024-11-19
00380657531769UNITYAlcon Laboratories, Inc.MLZ2024-11-19
10380657531759UNITYAlcon Laboratories, Inc.MLZ2024-11-19
10380657531766UNITYAlcon Laboratories, Inc.MLZ2024-11-19
00380650002501UNITYAlcon Laboratories, Inc.MLZ2024-07-02
00380657531677UNITYAlcon Laboratories, Inc.MLZ2024-07-02
00380657531684UNITYAlcon Laboratories, Inc.MLZ2024-07-02
00380657531790UNITYAlcon Laboratories, Inc.MLZ2024-07-02
10380650002508UNITYAlcon Laboratories, Inc.MLZ2024-07-02
10380657531674UNITYAlcon Laboratories, Inc.MLZ2024-07-02
10380657531681UNITYAlcon Laboratories, Inc.MLZ2024-07-02
10380657531797UNITYAlcon Laboratories, Inc.MLZ2024-07-02
00850005541042MICOR VitrectorCarl Zeiss Meditec, Cataract Technology, Inc.MLZ2023-07-28
00191072142832ACSAMERICAN CONTRACT SYSTEMS, INC.MLZ2021-08-10
00191072121974ACSAMERICAN CONTRACT SYSTEMS, INC.MLZ2021-01-27
00380650000958CONSTELLATION® HYPERVIT® TOTAL PLUS®Alcon Laboratories, Inc.MLZ2020-12-11
00380650000965CONSTELLATION® HYPERVIT® TOTAL PLUS®Alcon Laboratories, Inc.MLZ2020-12-11
00380657531066CONSTELLATION® HYPERVIT® TOTAL PLUS®Alcon Laboratories, Inc.MLZ2020-12-11
00380657531097CONSTELLATION® HYPERVIT® TOTAL PLUS®Alcon Laboratories, Inc.MLZ2020-12-11
10380650000955CONSTELLATION® HYPERVIT® TOTAL PLUS®Alcon Laboratories, Inc.MLZ2020-12-11
10380650000962CONSTELLATION® HYPERVIT® TOTAL PLUS®Alcon Laboratories, Inc.MLZ2020-12-11
10380657531063CONSTELLATION® HYPERVIT® TOTAL PLUS®Alcon Laboratories, Inc.MLZ2020-12-11
10380657531094CONSTELLATION® HYPERVIT® TOTAL PLUS®Alcon Laboratories, Inc.MLZ2020-12-11