MFR-200/240-HHz

GUDID 00855950006462

Surgical Laser Fiber 200/240/270/400 micron, silicone, blue tefzel, NA 0.22, SMA 905 HHz connector(TM), boot, reusable, extension sleeve, Flat Tip, 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 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 ID00855950006462
NIH Device Record Key4f45f885-4879-4bbe-bcf3-912e86c5f05e
Commercial Distribution StatusIn Commercial Distribution
Brand NameMFR-200/240-HHz
Version Model NumberMFR-200/240-HHZ
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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
GS100855950006462 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00855950006462]

Moist Heat or Steam Sterilization;Dry Heat Sterilization;Ethylene Oxide

[00855950006462]

Moist Heat or Steam Sterilization;Dry Heat Sterilization;Ethylene Oxide

[00855950006462]

Moist Heat or Steam Sterilization;Dry Heat Sterilization;Ethylene Oxide

[00855950006462]

Moist Heat or Steam Sterilization;Dry Heat Sterilization;Ethylene Oxide

[00855950006462]

Moist Heat or Steam Sterilization;Dry Heat Sterilization;Ethylene Oxide

[00855950006462]

Moist Heat or Steam Sterilization;Dry Heat Sterilization;Ethylene Oxide

[00855950006462]

Moist Heat or Steam Sterilization;Dry Heat Sterilization;Ethylene Oxide

[00855950006462]

Moist Heat or Steam Sterilization;Dry Heat Sterilization;Ethylene Oxide

[00855950006462]

Moist Heat or Steam Sterilization;Dry Heat Sterilization;Ethylene Oxide

[00855950006462]

Moist Heat or Steam Sterilization;Dry Heat Sterilization;Ethylene Oxide

[00855950006462]

Moist Heat or Steam Sterilization;Dry Heat Sterilization;Ethylene Oxide

[00855950006462]

Moist Heat or Steam Sterilization;Dry Heat Sterilization;Ethylene Oxide

[00855950006462]

Moist Heat or Steam Sterilization;Dry Heat Sterilization;Ethylene Oxide

[00855950006462]

Moist Heat or Steam Sterilization;Dry Heat Sterilization;Ethylene Oxide

[00855950006462]

Moist Heat or Steam Sterilization;Dry Heat Sterilization;Ethylene Oxide

[00855950006462]

Moist Heat or Steam Sterilization;Dry Heat Sterilization;Ethylene Oxide

[00855950006462]

Moist Heat or Steam Sterilization;Dry Heat Sterilization;Ethylene Oxide

[00855950006462]

Moist Heat or Steam Sterilization;Dry Heat Sterilization;Ethylene Oxide

[00855950006462]

Moist Heat or Steam Sterilization;Dry Heat Sterilization;Ethylene Oxide

[00855950006462]

Moist Heat or Steam Sterilization;Dry Heat Sterilization;Ethylene Oxide

[00855950006462]

Moist Heat or Steam Sterilization;Dry Heat Sterilization;Ethylene Oxide

[00855950006462]

Moist Heat or Steam Sterilization;Dry Heat Sterilization;Ethylene Oxide

[00855950006462]

Moist Heat or Steam Sterilization;Dry Heat Sterilization;Ethylene Oxide

[00855950006462]

Moist Heat or Steam Sterilization;Dry Heat Sterilization;Ethylene Oxide

[00855950006462]

Moist Heat or Steam Sterilization;Dry Heat Sterilization;Ethylene Oxide

[00855950006462]

Moist Heat or Steam Sterilization;Dry Heat Sterilization;Ethylene Oxide

[00855950006462]

Moist Heat or Steam Sterilization;Dry Heat Sterilization;Ethylene Oxide

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-09-24
Device Publish Date2018-08-22

Devices Manufactured by MED -FIBERS INC.

00855950006721 - TXMF400RZ2023-10-18 Radial Fiber 400um, Slim, No luer
00855950006738 - TXMF400R2023-10-18 Radial Fiber 400, Slim with tuohy borst
00855950006745 - TXMF600BFS2023-10-18 Bare Fiber 600um 3m, luer lock, SMA Connector, sterile
00855950006769 - TXMFR2002023-10-18 Surgical Laser Fiber ILT 200PI
00855950006776 - TXMFR400/4402023-10-18 Surgical Laser Fiber 400/440um, polyamide
00855950006783 - MF-400-HPCS2023-10-18 Surgical Laser Fiber, 400/430/750, hard clad, clear tefzel, NA0.37, standard SMA905, single use, EO sterile, no extension sleeve
00855950006608 - MFR-300/330PI2023-06-02 9073/300um Surgical Laser Fiber 300/330/370PI, silica/silica, polyimide, NA 0.22, standard SMA905, reusable, extension sleeves,
00855950006523 - MF-Tuohy Borst Adpaters (FLO30, Male Spin/Lock, Pediatric)2021-11-16 MF-Tuohy Borst Adpaters (MF FLO30, Male Spin/Lock, Pediatric)
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.