FDA.reportPublic FDA data

Adler MicroMed Laser Surgery Fiber

Primary DI
00850348007304
Brand
Adler MicroMed Laser Surgery Fiber
Company
ADLER MICROMED, INC.
Model
SFCS000235
Device description
Adler MicroMed Laser Surgery Fiber 2.5 NC 600 HSC 1.8
Published
2018-12-05
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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
K152417000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152417000Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.2015-12-01GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850348007311PackageGS15In Commercial Distribution
00850348007328PackageGS110In Commercial Distribution
00850348007304PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850348007311008503480073118503480073110850348007311
00850348007328008503480073288503480073280850348007328
00850348007304008503480073048503480073040850348007304

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
Ethylene Oxide

Regulatory Flags#

DUNS number
080298464
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
00850348007359Adler Hemorrhoid LigatorAdler Hemorrhoid LigatorAL90002024-02-24
00850348007403Adler MicroMed Laser Surgery Fiber 6350002356350002352024-02-12
00850348007434Adler MicroMed Laser Surgery Fiber 6310002886310002882024-02-12
00850348007465Adler MicroMed Laser Surgery Fiber 6310003026310003022024-02-12
00850348007496Adler MicroMed Laser Surgery Fiber 6310003046310003042024-02-12
00850348007526Adler MicroMed Laser Surgery Fiber 6310002966310002962024-02-12
00850348007410Adler MicroMed Laser Surgery Fiber 6350002356350002352024-02-12
00850348007441Adler MicroMed Laser Surgery Fiber 6310002886310002882024-02-12
00850348007472Adler MicroMed Laser Surgery Fiber 6310003026310003022024-02-12
00850348007502Adler MicroMed Laser Surgery Fiber 6310003046310003042024-02-12
00850348007533Adler MicroMed Laser Surgery Fiber 6310002966310002962024-02-12
00850348007182Adler MircroMed Laser Surgery FiberBFCS000288BFCS0002882018-07-09
00850348007243Adler MicroMed Laser Surgery FiberBFCS000302BFCS0003022018-11-13
00850348007007Adler MicroMed Laser Surgery FiberSFCS000099SFCS0000992016-10-17
00850348007373Adler MicroMed Laser Surgery Fiber 6360000996360000992023-11-24
00850348007380Adler MicroMed Laser Surgery Fiber 6360000996360000992023-11-24
00850348007335Hemorrhoid LigatorAL8000AL80002019-10-01
00850348007212Adler MicroMed Laser Surgery FiberBFCS000296BFCS0002962018-07-11
00850348007014Adler MicroMed Laster Surgery FiberSFCS000101SFCS0001012016-10-17
00850348007021Adler MicroMed Laser Surgery FiberSFCS000102SFCS0001022016-10-17

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08056389701122EPI-C PLUSESPANSIONE MARKETING SPAGEX2026-04-30
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08052049500326Splendor XBIOS SRLGEX2025-01-16
08052049500333Splendor XBIOS SRLGEX2025-01-16
08052049500340Splendor XBIOS SRLGEX2025-01-16
08052049500357Splendor XBIOS SRLGEX2025-01-16
00851842007623LightScalpelLightscalpel, LLCGEX2023-06-26
08057017760733DEKA TRUISTEL.EN. SPAGEX2023-04-27
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08059173390397Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-08-25
08059173390427Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-08-25
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08059173390724Single Use Sterile Surgical Optical Fiber QUANTA SYSTEM SPAGEX2020-05-27
08059173390755Single Use Sterile Surgical Optical Fiber QUANTA SYSTEM SPAGEX2020-05-27
08057017760429DEKA LUXEAEL.EN. SPAGEX2020-01-15
08056389700071E-LIGHT LINEESPANSIONE MARKETING SPAGEX2019-09-03
08056389700088E-LIGHT LINEESPANSIONE MARKETING SPAGEX2019-09-03
08057017760276DEKA SMARTXIDE²EL.EN. SPAGEX2019-03-15
08057017760283DEKA SMARTXIDE²EL.EN. SPAGEX2019-03-15
08057017760344DEKA MOTUS AYEL.EN. SPAGEX2019-03-15
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