FDA.reportPublic FDA data

MFR-365/400-A

Primary DI
00855950006066
Brand
MFR-365/400-A
Company
MED -FIBERS INC.
Model
MFR-365/400-A
Device description
Surgical Laser Fiber 365/400/580, hard clad, blue tefzel, NA 0.22, Absorbing Dark Hole Connector® SMA905, 5x reusable, gold extension sleeve, EO sterile, Flat Tip, MF label
Published
2016-09-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K124003000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K124003000MED-FIBERS SURGICAL LASER FIBER, MED-FIBERS ENDO-ENT LASER PROBES, MED-FIBERS END- AND ASPIRATING LASER PROBES, MED-FIBEMed-Fibers, Inc.2013-01-17GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855950006066PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855950006066008559500060668559500060660855950006066

GMDN Terms#

Term, Definition table
TermDefinition
General/multiple surgical laser system beam guide, reusableA surgical device intended to be connected to a general/multiple surgical laser system to invasively direct and deliver laser energy for multiple different surgical applications (non-dedicated), which may include vaporization, ablation, coagulation, haemostasis, excision, resection, incision of soft and cartilaginous tissue, and/or fragmentation of urinary and biliary calculi. It is typically a probe-, handpiece-, or tip-like device which includes fibreoptic materials. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
"[""Moist Heat or Steam Sterilization"", ""Ethylene Oxide""]"
Moist Heat or Steam Sterilization;Ethylene Oxide

Regulatory Flags#

DUNS number
058701385
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00855950006721TXMF400RZTXMF400RZ2023-10-10
00855950006738TXMF400RTXMF400R 2023-10-10
00855950006745TXMF600BFSTXMF600BFS2023-10-10
00855950006769TXMFR200TXMFR2002023-10-10
00855950006776TXMFR400/440TXMFR400/4402023-10-10
00855950006783MF-400-HPCSMF-400-HPCS2023-10-10
00855950006608MFR-300/330PIMFR-300/330PI2022-11-01
00855950006554MF-150/180-HHzMF-150/180-HHz2021-05-26
00855950006561MFR-150/180-HHzMFR-150/180-HHz2021-05-26
00855950006530MF-272/300-SBT-DTMF-272/300Series2021-03-31
0085595000654700855950006547MF-272/300Series2021-03-31
00855950006004MF-800/880-SBTMF-800/880-SBT2016-09-07
00855950006011MFR-1000/1100-HCBTMFR-1000/1100-HCBT2016-09-07
00855950006028MFR-200/240-AMFR-200/240-A2016-09-07
00855950006035MFR-200/240-SBTMFR-200/240-SBT2016-09-07
00855950006042MFR-272/300-AMFR-272/300-A2016-09-07
00855950006059MFR-272/300-SBTMFR-272/300-SBT2016-09-07
00855950006073MFR-365/400-SBTMFR-365/400-SBT2016-09-07
00855950006080MFR-550/600-HCBTMFR-550/600-HCBT2016-09-07
00855950006097MFR-800/880-SBTMFR-800/880-SBT2016-09-07

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