FDA.reportPublic FDA data

UNITY

Primary DI
10380657531681
Brand
UNITY
Company
Alcon Laboratories, Inc.
Model
00380657531684
Catalog number
8065753168
Device description
Anterior Vitrectomy Kit 7.5CPM 25+GA
Published
2024-07-02
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

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
10380657531681PackageGS16In Commercial Distribution
00380657531684PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038065753168110380657531681
00380657531684003806575316843806575316840380657531684

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00380658560270CLAREON VIVITY PROVNYWT0VNYWT0-0602026-11-02
00380658560287CLAREON VIVITY PROVNYWT0VNYWT0-0652026-11-02
00380658560294CLAREON VIVITY PROVNYWT0VNYWT0-0702026-11-02
00380658560300CLAREON VIVITY PROVNYWT0VNYWT0-0752026-11-02
00380658560317CLAREON VIVITY PROVNYWT0VNYWT0-0802026-11-02
00380658560324CLAREON VIVITY PROVNYWT0VNYWT0-0852026-11-02
00380658560331CLAREON VIVITY PROVNYWT0VNYWT0-0902026-11-02
00380658560348CLAREON VIVITY PROVNYWT0VNYWT0-0952026-11-02
00380658560355CLAREON VIVITY PROVNYWT0VNYWT0-1002026-11-02
00380658560362CLAREON VIVITY PROVNYWT0VNYWT0-1052026-11-02
00380658560379CLAREON VIVITY PROVNYWT0VNYWT0-1102026-11-02
00380658560386CLAREON VIVITY PROVNYWT0VNYWT0-1152026-11-02
00380658560393CLAREON VIVITY PROVNYWT0VNYWT0-1202026-11-02
00380658560409CLAREON VIVITY PROVNYWT0VNYWT0-1252026-11-02
00380658560416CLAREON VIVITY PROVNYWT0VNYWT0-1302026-11-02
00380658560423CLAREON VIVITY PROVNYWT0VNYWT0-1352026-11-02
00380658560430CLAREON VIVITY PROVNYWT0VNYWT0-1402026-11-02
00380658560447CLAREON VIVITY PROVNYWT0VNYWT0-1452026-11-02
00380658560454CLAREON VIVITY PROVNYWT0VNYWT0-1502026-11-02
00380658560461CLAREON VIVITY PROVNYWT0VNYWT0-1552026-11-02

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
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
00380658300777CONSTELLATION® 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