Re-Usable surgical optical fiber

GUDID 08051272101171

Re-Usable 10x 550um surgical optical fiber

HYPER PHOTONICS SRL

General/multiple surgical laser system beam guide, reusable
Primary Device ID08051272101171
NIH Device Record Keyd05ef82b-d5a1-4248-bed5-1b8e26a9c686
Commercial Distribution StatusIn Commercial Distribution
Brand NameRe-Usable surgical optical fiber
Version Model NumberBO000016
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 Usefalse
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
GS108051272101157 [Primary]
GS108051272101164 [Package]
Contains: 08051272101157
Package: carton box [5 Units]
In Commercial Distribution
GS108051272101171 [Package]
Contains: 08051272101164
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 Usetrue
Device Is Steriletrue

[08051272101171]

Moist Heat or Steam Sterilization


[08051272101171]

Moist Heat or Steam Sterilization


[08051272101171]

Moist Heat or Steam Sterilization


[08051272101171]

Moist Heat or Steam Sterilization


[08051272101171]

Moist Heat or Steam Sterilization


[08051272101171]

Moist Heat or Steam Sterilization


[08051272101171]

Moist Heat or Steam Sterilization


[08051272101171]

Moist Heat or Steam Sterilization


[08051272101171]

Moist Heat or Steam Sterilization


[08051272101171]

Moist Heat or Steam Sterilization


[08051272101171]

Moist Heat or Steam Sterilization


[08051272101171]

Moist Heat or Steam Sterilization


[08051272101171]

Moist Heat or Steam Sterilization


[08051272101171]

Moist Heat or Steam Sterilization


[08051272101171]

Moist Heat or Steam Sterilization


[08051272101171]

Moist Heat or Steam Sterilization


[08051272101171]

Moist Heat or Steam Sterilization


[08051272101171]

Moist Heat or Steam Sterilization


[08051272101171]

Moist Heat or Steam Sterilization


[08051272101171]

Moist Heat or Steam Sterilization


[08051272101171]

Moist Heat or Steam Sterilization


[08051272101171]

Moist Heat or Steam Sterilization


[08051272101171]

Moist Heat or Steam Sterilization


[08051272101171]

Moist Heat or Steam Sterilization


[08051272101171]

Moist Heat or Steam Sterilization


[08051272101171]

Moist Heat or Steam Sterilization


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 [Re-Usable surgical optical fiber]

08051272101218Re-Usable 10x 272um surgical optical fiber
08051272101171Re-Usable 10x 550um surgical optical fiber
08051272101119Re-Usable 10x 365um surgical optical fiber
08051272101058Re-Usable 10x 272um surgical optical fiber

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.