FDA.reportPublic FDA data

CONSTELLATION HYPERVIT ENGAUGE

Primary DI
10380658300262
Brand
CONSTELLATION HYPERVIT ENGAUGE
Company
Alcon Laboratories, Inc.
Model
8065830026
Device description
CONSTELLATION 25+ HYPERVIT Bevel, Vitrectomy Probe 20,000 cpm
Published
2020-08-31
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

Contact Domains#

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
K170520000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170520000HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+Alcon Research, Ltd.2017-03-22MLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10380658300262PackageGS16In Commercial Distribution
00380658300265PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038065830026210380658300262
00380658300265003806583002653806583002650380658300265

GMDN Terms#

Term, Definition table
TermDefinition
Vitrectomy system micro-cutting unitA sterile, pneumatically-powered, hand-held cutting tool that incorporates a vitrectomy system handpiece, micro-tip and connecting tubing as a single unit, intended to remove (nibble away) vitreous humour (the jelly-like substance that fills the centre of the eye) during ophthalmic surgery. The tubing transmits pneumatic power produced by a system generator to the handpiece which converts this into a mechanical oscillating-cutting action at the tip. This device will typically be activated by the surgeon using a foot control and provide or support the irrigation/suction systems needed to supply replacement fluid and remove debris. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07612717071582FINESSE REFLEX806.432022-06-22
07612717071612FINESSE REFLEX806.442022-06-22
07612717071629FINESSE REFLEX806.452022-06-22
07612717071636FINESSE REFLEX806.472022-06-22
00380657410859Alcon, Infiniti, MicroSmooth, ABS80657410852016-09-24
00380657410873Alcon, Infiniti, MicroSmooth, Kelman, ABS80657410872016-09-24
00380657410972Alcon, Infiniti, MicroSmooth, ABS80657410972016-09-24
00380657502806Alcon, Infiniti, MicroSmooth, ABS80657502802016-09-24
00380657517190Alcon, Infiniti, Intrepid, ABS80657517192016-09-24
00380657520886Alcon, Infiniti, Intrepid80657520882016-09-24
00300650193108OPTI-FREE EXPRESSOPTI-FREE EXPRESS 10ml2016-09-24
00300650193207OPTI-FREE EXPRESSOPTI-FREE EXPRESS 20ml2016-09-24
00380657402601Alcon80657402602016-09-24
00380652268899ACRYSOF, IQ RESTORSND1T3SND1T3U1302017-02-24
00380658552008Clareon TruPlusREYWT8REYWT8.2502026-05-14
00380658552015Clareon TruPlusREYWT8REYWT8.2552026-05-14
00380658552022Clareon TruPlusREYWT8REYWT8.2602026-05-14
00380658552039Clareon TruPlusREYWT8REYWT8.2652026-05-14
00380658552046Clareon TruPlusREYWT8REYWT8.2702026-05-14
00380658552053Clareon TruPlusREYWT8REYWT8.2752026-05-14

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
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