FDA.reportPublic FDA data

NA

Primary DI
00878953000213
Brand
NA
Company
AMERICAN MEDICAL SYSTEMS
Model
0010-0814
Device description
Microstat, 9cm Curved Surgical Laser Handpieces
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00878953000213PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00878953000213008789530002138789530002130878953000213

GMDN Terms#

Term, Definition table
TermDefinition
Laser beam delivery unit holderA device designed to be used together with a laser delivery unit to provide support to the delivery unit during the operation of the laser. The holder will help with the positioning of the final laser beam output and increase safety from inadvertent movement which would be undesirable. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length9Centimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
796308653
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00878953000237NA0010-00412016-09-24
00878953000343NA0010-08132016-09-24
00878953000848NA0010-08332016-09-24
00878953007670NA0010-08322016-09-24
00878953000244NA0010-00452016-09-24
00878953000251NA0010-00462016-09-24
00878953000268NA0010-00472016-09-24
00878953000275NA0010-62112016-09-24
00878953000282NA0010-62122016-09-24
00878953000299NA0010-08512016-09-24
00878953000305NA0010-08522016-09-24
00878953000329NA0010-08112016-09-24
00878953000336NA0010-08122016-09-24
00878953000350NA0010-0441 2016-09-24
00878953000367NA0010-04442016-09-24
00878953000374NA0010-04462016-09-24
00878953000381NA0010-09912016-09-24
00878953000398NA0010-09922016-09-24
00878953000404NA0010-09932016-09-24
00878953000411NA0010-09942016-09-24

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Primary DI, Brand, Company table
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04053002150613CORONA Infinite Ring XSCF 600 1.6 USLight Guide Optics International SIAGEX2026-08-14
04053002150712Rigid Infinite Ring HSC Probe 600 1.8 USLight Guide Optics International SIAGEX2026-08-14
06973011720080CO2 Laser Therapy SystemSanhe LEFIS Electronics Co., LtdGEX2026-08-07
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08800079000039Laser tip-MGTHULASER, Inc.GEX2026-07-29
08800079000046Laser tip-METHULASER, Inc.GEX2026-07-29
08800079000091K2 mobile coverHULASER, Inc.GEX2026-07-29
07290110124175FemiLift Sterile SleeveALMA LASERS LTD.GEX2026-07-26
EOBN210188S0NAOBERON GmbH Fiber TechnologiesGEX2026-07-22
08800020109439TRI-BEAM ARMJeisys Medical Inc.GEX2026-07-21
08800020111845P-NAIN SYSTEMJeisys Medical Inc.GEX2026-07-21
008164690217041150-50TLASER PERIPHERALS, LLCGEX2026-07-20
00816995027850Fraxel FTXSOLTA MEDICALGEX2026-07-20
00816995027867Fraxel FTXSOLTA MEDICALGEX2026-07-20
00816995027874Fraxel FTXSOLTA MEDICALGEX2026-07-20
00816995027904Fraxel FTXSOLTA MEDICALGEX2026-07-20
06974851082079BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
06974851082086BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
06974851088019BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
08800020106322TRI-BEAMJeisys Medical Inc.GEX2026-07-16
08800020109446TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109453TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16