FDA.reportPublic FDA data

Procedure Pack Z8

Primary DI
07640167751358
Brand
Procedure Pack Z8
Company
SIE AG, Surgical Instrument Engineering
Model
9.0 CS Z8 S
Catalog number
510.700.121
Device description
Procedure Pack Corneal Surgery 9.0 SLIM
Published
2020-12-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OOEOphthalmic Femtosecond Laser

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OOEOphthalmic Femtosecond LaserOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150323000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150323000FEMTO LDV Z8 Surgical LaserSie Ag,Surgical Instrument Engineering2015-10-23OOE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640167751297PackageGS110In Commercial Distribution
07640167751358PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640167751297076401677512977640167751297
07640167751358076401677513587640167751358

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Lumen/Inner Diameter9Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8667084490usa@ziemergroup.com

Regulatory Flags#

DUNS number
482163628
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640167750023FEMTO LDVZ6510.003.0062016-09-15
07640167750030FEMTO LDVZ4510.003.0042016-09-15
07640167750047FEMTO LDVZ2510.003.0022016-09-15
07640167750573FEMTOZ8 NEO510.003.0092022-06-10
07640167751334Procedure Pack Z8Cataract L2510.700.1192020-12-22
07640167751341Procedure Pack Z88.5 CS Z8 S510.700.1202020-12-22
07640167751365Procedure Pack Z89.5 CS Z8 S510.700.1222020-12-22
07640167751372Procedure Pack Z810.0 CS Z8 S510.700.1232020-12-22
07640167751389Procedure Pack Z8L2510.700.1242020-12-22
07640167750092Procedure Pack10/100510.701.1402018-09-14
07640167750108Procedure Pack10/110510.701.1412018-09-14
07640167750115Procedure Pack10/140510.701.1442018-09-14
07640167750122Procedure Pack10/90510.701.1492018-09-14
07640167750139Procedure Pack8.5/100510.701.1102018-09-14
07640167750146Procedure Pack8.5/110510.701.1112018-09-14
07640167750153Procedure Pack8.5/140510.701.1142018-09-14
07640167750160Procedure Pack8.5/90510.701.1192018-09-14
07640167750177Procedure Pack9.0/100510.701.1202018-09-14
07640167750184Procedure Pack9.0/110510.701.1212018-09-14
07640167750191Procedure Pack9.0/140510.701.1242018-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850062486027LLS/ALLYLENSAR, Inc.OOE2026-04-13
00867744000167LLS/ALLYLENSAR, Inc.OOE2026-04-13
00867744000174LLS/ALLYLENSAR, Inc.OOE2026-04-13
00867744000181ALLYLENSAR, Inc.OOE2026-04-13
00380650009449LenSxAlcon Laboratories, Inc.OOE2025-10-01
04050555002086Patient Interface 125 KitTechnolas Perfect Vision GmbHOOE2024-03-13
00867744000150ALLYLENSAR, Inc.OOE2023-08-18
10867744000157ALLYLENSAR, LLCOOE2023-08-18
05050474655690INTRALASE TECHNOLOGY PIJOHNSON & JOHNSON SURGICAL VISION, INC.OOE2023-08-11
05050474655706INTRALASE TECHNOLOGY PIJOHNSON & JOHNSON SURGICAL VISION, INC.OOE2023-08-11
05050474738553ELITAJOHNSON & JOHNSON SURGICAL VISION, INC.OOE2023-08-11
07640167750573FEMTOSIE AG, Surgical Instrument EngineeringOOE2022-06-10
07640167751334Procedure Pack Z8SIE AG, Surgical Instrument EngineeringOOE2020-12-22
07640167751341Procedure Pack Z8SIE AG, Surgical Instrument EngineeringOOE2020-12-22
07640167751365Procedure Pack Z8SIE AG, Surgical Instrument EngineeringOOE2020-12-22
07640167751372Procedure Pack Z8SIE AG, Surgical Instrument EngineeringOOE2020-12-22
07640167751389Procedure Pack Z8SIE AG, Surgical Instrument EngineeringOOE2020-12-22
05050474709508CATALYS SYSTEMOPTIMEDICA CORPORATIONOOE2020-08-19
07640167750511Procedure Pack Z8SIE AG, Surgical Instrument EngineeringOOE2018-09-14
07640167750528Procedure Pack Z8SIE AG, Surgical Instrument EngineeringOOE2018-09-14
07640167750542Procedure Pack Z8SIE AG, Surgical Instrument EngineeringOOE2018-09-14
07640167750566Procedure Pack Z8SIE AG, Surgical Instrument EngineeringOOE2018-09-14
07640167750580Procedure Pack Z8SIE AG, Surgical Instrument EngineeringOOE2018-09-14
07640167750603Procedure Pack Z8SIE AG, Surgical Instrument EngineeringOOE2018-09-14
07640167750627Procedure Pack Z8SIE AG, Surgical Instrument EngineeringOOE2018-09-14
07640167751051Procedure Pack Z8SIE AG, Surgical Instrument EngineeringOOE2018-09-14
07640167751068Procedure Pack Z8SIE AG, Surgical Instrument EngineeringOOE2018-09-14
07640167751082Procedure Pack Z8SIE AG, Surgical Instrument EngineeringOOE2018-09-14
07640167751143Procedure Pack Z8SIE AG, Surgical Instrument EngineeringOOE2018-09-14
07640167751129Procedure Pack Z8SIE AG, Surgical Instrument EngineeringOOE2018-09-14