FDA.reportPublic FDA data

Adler MircroMed Laser Surgery Fiber

Primary DI
00850348007182
Brand
Adler MircroMed Laser Surgery Fiber
Company
ADLER MICROMED, INC.
Model
BFCS000288
Catalog number
BFCS000288
Device description
Adler MircroMed laser Surgery Fiber 3.0 NC 270 HGT 420
Published
2018-07-09
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
00850348007199PackageGS15Not in Commercial Distribution
00850348007205PackageGS110Not in Commercial Distribution
00850348007182PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850348007199008503480071998503480071990850348007199
00850348007205008503480072058503480072050850348007205
00850348007182008503480071828503480071820850348007182

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; a fibreoptic cable may be included with the device. This is a reusable device.

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
00850348007243Adler MicroMed Laser Surgery FiberBFCS000302BFCS0003022018-11-13
00850348007007Adler MicroMed Laser Surgery FiberSFCS000099SFCS0000992016-10-17
00850348007304Adler MicroMed Laser Surgery FiberSFCS0002352018-12-05
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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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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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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