Procedure Pack 510.701.193

GUDID 07640167750894

Procedure Pack LCS Ø 9.5mm

SIE AG, Surgical Instrument Engineering

Ophthalmic surgical procedure kit, non-medicated, single-use
Primary Device ID07640167750894
NIH Device Record Keyce80a140-0040-4d91-aef8-91687916f945
Commercial Distribution StatusIn Commercial Distribution
Brand NameProcedure Pack
Version Model Number9.5 LCS
Catalog Number510.701.193
Company DUNS482163628
Company NameSIE AG, Surgical Instrument Engineering
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8667084490
Emailusa@ziemergroup.com

Device Dimensions

Lumen/Inner Diameter9.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS107640167750351 [Primary]
GS107640167750894 [Package]
Contains: 07640167750351
Package: Carton [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HNOKeratome, Ac-Powered

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-11-08
Device Publish Date2018-09-14

On-Brand Devices [Procedure Pack]

07640167751044Procedure Pack LASIK Ø 9.5mm
07640167751037Procedure Pack LASIK Ø 9.0mm
07640167751020Procedure Pack LASIK Ø 8.5mm
07640167751013Procedure Pack LASIK Ø 10.0mm
07640167751006Procedure Pack Corneal Surgery Ø 9.5mm
07640167750450Procedure Pack Corneal Surgery Ø 9.0mm
07640167750986Procedure Pack Corneal Surgery Ø 8.5mm
07640167750979Procedure Pack Corneal Surgery Ø 10.0mm
07640167750962Procedure Pack Advanced Corneal Surgery Ø 9.5mm
07640167750412Procedure Pack Advanced Corneal Surgery Ø 9.0mm
07640167750948Procedure Pack Advanced Corneal Surgery Ø 8.5mm
07640167750931Procedure Pack Advanced Corneal Surgery Ø 10.0mm
07640167750894Procedure Pack LCS Ø 9.5mm
07640167750887Procedure Pack LCS Ø 9.0mm
07640167750870Procedure Pack LCS Ø 8.5mm
07640167750863Procedure Pack LCS Ø 10.0mm
07640167750788Procedure Pack Ø 9.5mm, 90µm flap thickness
07640167750771Procedure Pack Ø 9.5mm, 140µm flap thickness
07640167750764Procedure Pack Ø 9.5mm, 110µm flap thickness
07640167750757Procedure Pack Ø 9.5mm,100µm flap thickness
07640167750740Procedure Pack Ø 9.0mm, 90µm flap thickness
07640167750733Procedure Pack Ø 9.0mm, 140µm flap thickness
07640167750726Procedure Pack Ø 9.0mm, 110µm flap thickness
07640167750719Procedure Pack Ø 9.0mm,100µm flap thickness
07640167750702Procedure Pack Ø 8.5mm, 90µm flap thickness
07640167750696Procedure Pack Ø 8.5mm, 140µm flap thickness
07640167750689Procedure Pack Ø 8.5mm,110µm flap thickness
07640167750672Procedure Pack Ø 8.5mm,100µm flap thickness
07640167750665Procedure Pack Ø 10.0mm, 90µm flap thickness
07640167750658Procedure Pack Ø 10.0mm, 140µm flap thickness
07640167750641Procedure Pack Ø 10.0mm, 110µm flap thickness
07640167750634Procedure Pack 10.0 mm, 100um flap Thickness
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