FDA.reportPublic FDA data

Zyoptix® XP Microkeratome Disposable Blades

Primary DI
04050555000983
Brand
Zyoptix® XP Microkeratome Disposable Blades
Company
Technolas Perfect Vision GmbH
Model
1
Catalog number
5070070
Device description
Disposable blades for ZYOPTIX® XP Microkeratome.
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HNOKeratome, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNOKeratome, Ac-PoweredOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04050555000983PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04050555000983040505550009834050555000983

GMDN Terms#

Term, Definition table
TermDefinition
Keratome, line-poweredA mains electricity (AC-powered) ophthalmic surgical instrument intended to shave tissue from sections of the cornea for a lamellar (partial thickness) transplant. This device will typically have a special blade mounted to it for the cutting process.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4989940040info@technolaspv.com

Regulatory Flags#

DUNS number
341325716
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
04050555002086Patient Interface 125 Kit900001452024-03-13
04050555000990Patient Interface 125 Kit1900001152016-09-24
04050555004165VICTUS VERAFIT Patient Interface Kit190000200TPV2016-12-05
04050555004202TECHNOLAS TENEO 317Model22023-12-17
04050555000839MICROKERATOME Disposable Tubing150700632016-09-24
04050555000976ACCUGLIDE® Disposable Blade150700602016-09-19
04050555002895VICTUS™ Femtosecond Laser Platform3.2140002016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10810003224757NAMICROSPECIALITIES, INC.HNO2026-04-29
10810003224764NAMICROSPECIALITIES, INC.HNO2026-04-29
10810003224771NAMICROSPECIALITIES, INC.HNO2026-04-29
10810003224788NAMICROSPECIALITIES, INC.HNO2026-04-29
10810003224795NAMICROSPECIALITIES, INC.HNO2026-04-29
10810003224801NAMICROSPECIALITIES, INC.HNO2026-04-29
10810003224818NAMICROSPECIALITIES, INC.HNO2026-04-29
00380650004529Wave Light FS200 EASYPACKAlcon Laboratories, Inc.HNO2025-11-20
03700483603121MORIAMORIA SAHNO2024-05-07
03700483603145MORIAMORIA SAHNO2024-05-07
03700483603169MORIAMORIA SAHNO2024-05-07
03700483603183MORIAMORIA SAHNO2024-05-07
03700483603206MORIAMORIA SAHNO2024-05-07
03700483603220MORIAMORIA SAHNO2024-05-07
03700483603244MORIAMORIA SAHNO2024-05-07
03700483603374MORIAMORIA SAHNO2024-05-07
03700483603398MORIAMORIA SAHNO2024-05-07
03700483603930MORIAMORIA SAHNO2024-05-07
03700483603954MORIAMORIA SAHNO2024-05-07
03700483603138MORIAMORIA SAHNO2024-05-07
03700483603152MORIAMORIA SAHNO2024-05-07
03700483603176MORIAMORIA SAHNO2024-05-07
03700483603190MORIAMORIA SAHNO2024-05-07
03700483603213MORIAMORIA SAHNO2024-05-07
03700483603237MORIAMORIA SAHNO2024-05-07
03700483603251MORIAMORIA SAHNO2024-05-07
03700483603381MORIAMORIA SAHNO2024-05-07
03700483603404MORIAMORIA SAHNO2024-05-07
03700483603947MORIAMORIA SAHNO2024-05-07
03700483603961MORIAMORIA SAHNO2024-05-07