FEMTO LDVᵀᴹ Intershields 510.710.320

GUDID 07640167750801

Intershield d300 for LCS

SIE AG, Surgical Instrument Engineering

Ophthalmic surgical procedure kit, non-medicated, single-use
Primary Device ID07640167750801
NIH Device Record Key960fd249-283a-4e68-839d-55af0c88bdb3
Commercial Distribution StatusIn Commercial Distribution
Brand NameFEMTO LDVᵀᴹ Intershields
Version Model Numberd300
Catalog Number510.710.320
Company DUNS482163628
Company NameSIE AG, Surgical Instrument Engineering
Device Count10
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
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

Depth300 Micrometer

Device Identifiers

Device Issuing AgencyDevice ID
GS107640167750269 [Unit of Use]
GS107640167750801 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HQFLaser, Ophthalmic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-08
Device Publish Date2016-09-22

On-Brand Devices [FEMTO LDVᵀᴹ Intershields]

07640167750856Intershield d450 for LCS
07640167750849Intershield d420 for LCS
07640167750832Intershield d390 for LCS
07640167750825Intershield d360 for LCS
07640167750818Intershield d330 for LCS
07640167750801Intershield d300 for LCS
07640167750795d200

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