miLOOP

GUDID 30860000122307

Ophthalmic soft-tissue manipulation forceps, probe-like, single-use

Primary Device ID	30860000122307
NIH Device Record Key	56f3ad01-82cf-4543-9a7d-54ce61383e4e
Commercial Distribution Status	In Commercial Distribution
Brand Name	miLOOP
Version Model Number	104
Company DUNS	080125056
Company Name	IANTECH, INC.
Device Count	5
DM Exempt	true
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00860000122306 [Primary]
GS1	10860000122303 [Unit of Use]
GS1	30860000122307 [Package] Contains: 00860000122306 Package: Corrugated Cardboard [6 Units] In Commercial Distribution

HNQ	Hook, Ophthalmic

Steralize Prior To Use	false
Device Is Sterile	true

10860000122365 - MICOR extractor	2021-02-08 Disposable ophthalmic instrument for the removal of cataracts. Connects to MICOR drive FG-50631.
30860000122376 - MICOR drive	2021-02-08 Reusable ophthalmic instrument for the removal of cataracts. Connects to MICOR extractor or MICOR vitrector
30860000122307 - miLOOP	2019-07-12Ophthalmic Instrument. Lens Fragmentation Device.
30860000122307 - miLOOP	2019-07-12 Ophthalmic Instrument. Lens Fragmentation Device.

Mark Image Registration \| Serial	Company Trademark Application Date
MILOOP 87253471 5388005 Live/Registered	Carl Zeiss Meditec Cataract Technology Inc. 2016-12-01