Single use surgical optical fiber

GUDID 08051272101263

272um surgical optical fiber

HYPER PHOTONICS SRL

General/multiple surgical laser system beam guide, single-use
Primary Device ID08051272101263
NIH Device Record Key8f523461-179f-4ced-bd37-ed4539e1573b
Commercial Distribution StatusIn Commercial Distribution
Brand NameSingle use surgical optical fiber
Version Model NumberBO000019
Company DUNS430142152
Company NameHYPER PHOTONICS SRL
Device Count1
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

Device Identifiers

Device Issuing AgencyDevice ID
GS108051272101249 [Primary]
GS108051272101256 [Package]
Contains: 08051272101249
Package: carton box [5 Units]
In Commercial Distribution
GS108051272101263 [Package]
Contains: 08051272101256
Package: carton box [2 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2021-04-07
Device Publish Date2018-02-16

On-Brand Devices [Single use surgical optical fiber]

08051272101263272um surgical optical fiber
08051272101195550um surgical optical fiber
08051272101140365um surgical optical fiber
08051272101089200um surgical optical fiber

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