00855950006547

GUDID 00855950006547

Surgical Laser Fiber 272/300/380/450 micron, silicone, blue tefzel, NA 0.22, SMA 905 SMA 905 HHz connector(TM), blue boot, single use, blue extension sleeve, Dome Tip, MF label

MED -FIBERS INC.

General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable
Primary Device ID00855950006547
NIH Device Record Key9722e0fa-3ad7-49fa-ae95-cccd2ed5b55b
Commercial Distribution StatusIn Commercial Distribution
Brand Name00855950006547
Version Model NumberMF-272/300Series
Company DUNS058701385
Company NameMED -FIBERS INC.
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100855950006547 [Primary]

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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-08
Device Publish Date2021-03-31

Devices Manufactured by MED -FIBERS INC.

00855950006530 - MF-272/300-SBT-DT2021-04-08 Surgical Laser Fiber 272/300/380/450 micron, silicone, blue tefzel, NA 0.22, SMA 905, blue boot, single use, blue extension slee
00855950006547 - 008559500065472021-04-08Surgical Laser Fiber 272/300/380/450 micron, silicone, blue tefzel, NA 0.22, SMA 905 SMA 905 HHz connector(TM), blue boot, single use, blue extension sleeve, Dome Tip, MF label
00855950006547 - 008559500065472021-04-08 Surgical Laser Fiber 272/300/380/450 micron, silicone, blue tefzel, NA 0.22, SMA 905 SMA 905 HHz connector(TM), blue boot, sing
00855950006417 - MF-800/880-SBT-2mmCB2018-09-24 Surgical Laser Fiber 800/880/1180, silicone, blue tefzel, NA 0.22, damage resistant SMA905, single use, gold extensions sleeve,E
00855950006424 - MF-200/240-HHZ2018-09-24 Surgical Laser Fiber 200/240/290/400 micron, silicone, blue tefzel, NA 0.22, SMA 905 HHz Connector(TM), boot, single use, exten
00855950006431 - MF-272/300-HHz2018-09-24 Surgical Laser Fiber 272/300/380/450 micron, silicone, blue tefzel, NA 0.22, SMA 905 HHz Connector(TM), boot, single use, exten
00855950006448 - MF-365/400-HHz2018-09-24 Surgical Laser Fiber 365/400/470/580 micron, silicone, blue tefzel, NA 0.22, SMA 905 HHz Connector(TM), boot, single use, exten
00855950006455 - MF-550/600-HHz2018-09-24 Surgical Laser Fiber 550/600/635/750 micron, hard clad, blue tefzel, NA 0.22, SMA 905 HHz Connector(TM), boot, single use, exte
00855950006462 - MFR-200/240-HHz2018-09-24 Surgical Laser Fiber 200/240/270/400 micron, silicone, blue tefzel, NA 0.22, SMA 905 HHz connector(TM), boot, reusable, extensi

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