FDA.reportPublic FDA data

MICOR Vitrector

Primary DI
00850005541042
Brand
MICOR Vitrector
Company
Carl Zeiss Meditec, Cataract Technology, Inc.
Model
FG-50829
Device description
Ophthalmic Anterior Vitrectomy Device
Published
2023-07-28
Public version status
New
Distribution status
Not 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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200584000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200584000xPORT 304 (miCOR) System Lens Fragmentation SystemCarl Zeiss Meditec Cataract Technology, Inc.2020-07-31HQC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850005541042PrimaryGS10
10850005541049Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850005541042008500055410428500055410420850005541042
1085000554104910850005541049

GMDN Terms#

Term, Definition table
TermDefinition
Phacoemulsification systemAn assembly of ophthalmic devices intended to deliver energy (e.g., ultrasonic, piezoelectric) through a dedicated handpiece tip, which is introduced through an incision made in the lens capsule, to perform phacoemulsification (a procedure for the liquefaction and removal of the opaque lens nucleus in cataract surgery). The system will typically consist of a mains electricity (AC-powered) generator providing the energy, an irrigation and suction system for the removal of the debris, handpieces and cables, the tips/needles/electrodes, and a foot control.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080125056
Device count
2
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850005541080MICOR Auto I/AFG-518202025-08-19
00850005541073miLOOP reusableFG-508962024-08-30
00860000122306miLOOP1042019-02-12
30850005541074miLOOP reusableFG-508962024-08-30
00860000122368MICOR extractorFG-506212021-01-29
00860000122375MICOR driveFG-506312021-01-29

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
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