Procedure Pack Z8 510.700.112

GUDID 07640167751129

Procedure Pack Corneal Surgery 8.5

SIE AG, Surgical Instrument Engineering

Ophthalmic surgical procedure kit, non-medicated, single-use
Primary Device ID07640167751129
NIH Device Record Key92fb2aad-0b8d-43e9-a7e6-83cc93802b1c
Commercial Distribution StatusIn Commercial Distribution
Brand NameProcedure Pack Z8
Version Model Number8.5 CS Z8
Catalog Number510.700.112
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 Diameter8.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS107640167750580 [Primary]
GS107640167751129 [Package]
Contains: 07640167750580
Package: Carton [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OOEOphthalmic Femtosecond Laser

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 Z8]

07640167751167Procedure Pack Corneal Surgery 9.5
07640167751105Procedure Pack Corneal Surgery 9.0
07640167751129Procedure Pack Corneal Surgery 8.5
07640167751143Procedure Pack Corneal Surgery 10.5
07640167751082Procedure Pack Corneal Surgery 10.0
07640167751068Procedure Pack for Cataract Surgery
07640167751051Procedure Pack Corneal Surgery Liquid
07640167751389Procedure Pack Corneal Surgery Liquid SLIM
07640167751372Procedure Pack Corneal Surgery 10.0 SLIM
07640167751365Procedure Pack Corneal Surgery 9.5 SLIM
07640167751358Procedure Pack Corneal Surgery 9.0 SLIM
07640167751341Procedure Pack Corneal Surgery 8.5 SLIM
07640167751334Procedure Pack for Cataract Surgery SLIM

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