Adler MicroMed Laser Surgery Fiber SFCS000145

GUDID 00850348007038

Adler MicroMed Laser Surgery Fiber 2.5 NC 600 FSC 1.8

ADLER MICROMED, 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 ID00850348007038
NIH Device Record Key520e1c22-feea-42af-a8f4-3c754ade9964
Commercial Distribution StatusIn Commercial Distribution
Brand NameAdler MicroMed Laser Surgery Fiber
Version Model NumberSFCS000145
Catalog NumberSFCS000145
Company DUNS080298464
Company NameADLER MICROMED, 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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850348007038 [Primary]
GS100850348007090 [Package]
Package: [5 Units]
In Commercial Distribution
GS100850348007151 [Package]
Package: [10 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

[00850348007038]

Ethylene Oxide


[00850348007038]

Ethylene Oxide


[00850348007038]

Ethylene Oxide


[00850348007038]

Ethylene Oxide


[00850348007038]

Ethylene Oxide


[00850348007038]

Ethylene Oxide


[00850348007038]

Ethylene Oxide


[00850348007038]

Ethylene Oxide


[00850348007038]

Ethylene Oxide


[00850348007038]

Ethylene Oxide


[00850348007038]

Ethylene Oxide


[00850348007038]

Ethylene Oxide


[00850348007038]

Ethylene Oxide


[00850348007038]

Ethylene Oxide


[00850348007038]

Ethylene Oxide


[00850348007038]

Ethylene Oxide


[00850348007038]

Ethylene Oxide


[00850348007038]

Ethylene Oxide


[00850348007038]

Ethylene Oxide


[00850348007038]

Ethylene Oxide


[00850348007038]

Ethylene Oxide


[00850348007038]

Ethylene Oxide


[00850348007038]

Ethylene Oxide


[00850348007038]

Ethylene Oxide


[00850348007038]

Ethylene Oxide


[00850348007038]

Ethylene Oxide


[00850348007038]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2016-10-17

On-Brand Devices [Adler MicroMed Laser Surgery Fiber]

00850348007304Adler MicroMed Laser Surgery Fiber 2.5 NC 600 HSC 1.8
00850348007274Adler MicroMed Laser Surgery Fiber 2.5 NC 400 T 750
00850348007267Adler MicroMed Laser Surgery Luer Lock 600 NA 0.37 2.5m
00850348007236Adler MicroMed Laser Surgery Fiber 3.0 NC 270 HGT 420 RT
00850348007052Adler MicroMed Laser Surgery Fiber 2.5 NC 360 BT 395
00850348007038Adler MicroMed Laser Surgery Fiber 2.5 NC 600 FSC 1.8
00850348007021Adler MicroMed Laser Surgery Fiber 2.5 NC 600 HSC 1.8
00850348007007Adler MicroMed Laser Surgery Fiber 2.5 NC 600 RSCF 1.8
00850348007380Adler MicroMed Laser Surgery Fiber 2.5 NC 600 RSCF 1.8
00850348007533Adler MicroMed Laser Surgery Fiber 3.0 NC 270 GT 420 RT
00850348007502Adler MicroMed Laser Surgery Fiber 2.5 NC 400 T 750
00850348007472Adler MicroMed Laser Surgery Luer Lock Fiber 600 um NA 0.37 2.5m
00850348007441Adler MicroMed Laser Surgery Fiber 3.0 NC 270 HGT 420
00850348007410Adler MicroMed Laser Surgery Fiber 2.5 NC 600 HSC 1.8

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