FDA.reportPublic FDA data

Procedure Pack

Primary DI
07640167750351
Brand
Procedure Pack
Company
SIE AG, Surgical Instrument Engineering
Model
9.5 LCS
Catalog number
510.701.193
Device description
Procedure Pack LCS Ø 9.5mm
Published
2018-09-14
Public version status
Update
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
GEXPowered Laser Surgical Instrument
HNOKeratome, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2
HNOKeratome, Ac-PoweredOphthalmic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K053511000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K053511000DA VINCI FEMTOSECOND SURGICAL LASERSie Ltd Surgical Instrument Engineering2006-03-10GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640167750894PackageGS110In Commercial Distribution
07640167750351PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640167750894076401677508947640167750894
07640167750351076401677503517640167750351

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 Diameter9.5Millimeter

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
07640167751358Procedure Pack Z89.0 CS Z8 S510.700.1212020-12-22
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974077940016MLKJWeifang Mingliang Electronics Co., Ltd.GEX2026-05-27
07898672792193Medical SanMEDICAL SAN INDUSTRIA DE EQUIPAMENTOS MEDICOS LTDAGEX2026-05-27
07898672790823Medical SanMEDICAL SAN INDUSTRIA DE EQUIPAMENTOS MEDICOS LTDAGEX2026-05-12
08056389701122EPI-C PLUSESPANSIONE MARKETING SPAGEX2026-04-30
08034108513317DEKA LUXEA PLUSDEKA M.E.L.A. SRLGEX2025-12-16
08052049500326Splendor XBIOS SRLGEX2025-01-16
08052049500333Splendor XBIOS SRLGEX2025-01-16
08052049500340Splendor XBIOS SRLGEX2025-01-16
08052049500357Splendor XBIOS SRLGEX2025-01-16
00851842007623LightScalpelLightscalpel, LLCGEX2023-06-26
08057017760733DEKA TRUISTEL.EN. SPAGEX2023-04-27
08033945937645Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-04-06
08033945939052Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-04-06
08057017760429DEKA LUXEAEL.EN. SPAGEX2020-01-15
08056389700071E-LIGHT LINEESPANSIONE MARKETING SPAGEX2019-09-03
08056389700088E-LIGHT LINEESPANSIONE MARKETING SPAGEX2019-09-03
08057017760276DEKA SMARTXIDE²EL.EN. SPAGEX2019-03-15
08057017760283DEKA SMARTXIDE²EL.EN. SPAGEX2019-03-15
08057017760344DEKA MOTUS AYEL.EN. SPAGEX2019-03-15
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08059173390069Twain EvoQUANTA SYSTEM SPAGEX2018-12-14
08059173390076Twain EvoQUANTA SYSTEM SPAGEX2018-12-14
08059173390083Twain EvoQUANTA SYSTEM SPAGEX2018-12-14
08059173390090Twain EvoQUANTA SYSTEM SPAGEX2018-12-14
08059173390106Twain EvoQUANTA SYSTEM SPAGEX2018-12-14
08059173390113Twain EvoQUANTA SYSTEM SPAGEX2018-12-14
08059173390120Twain EvoQUANTA SYSTEM SPAGEX2018-12-14
08059173390038Olympus Empower H35 QUANTA SYSTEM SPAGEX2018-12-04
08059173390045Olympus Empower H65QUANTA SYSTEM SPAGEX2018-12-04
08059173390052Olympus Empower H100QUANTA SYSTEM SPAGEX2018-12-04