Re-Usable surgical optical fiber

GUDID 08051272101171

Re-Usable 10x 550um surgical optical fiber

HYPER PHOTONICS SRL

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Primary Device ID	08051272101171
NIH Device Record Key	d05ef82b-d5a1-4248-bed5-1b8e26a9c686
Commercial Distribution Status	In Commercial Distribution
Brand Name	Re-Usable surgical optical fiber
Version Model Number	BO000016
Company DUNS	430142152
Company Name	HYPER PHOTONICS SRL
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
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 Identifiers

Device Issuing Agency	Device ID
GS1	08051272101157 [Primary]
GS1	08051272101164 [Package] Contains: 08051272101157 Package: carton box [5 Units] In Commercial Distribution
GS1	08051272101171 [Package] Contains: 08051272101164 Package: carton box [2 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K163449

FDA Product Code

GEX	Powered Laser Surgical Instrument