FDA.reportPublic FDA data

NA

Primary DI
01858028005106
Brand
NA
Company
ACQUIRE MED
Model
Q-365-RTR
Catalog number
097275
Published
2016-09-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
false

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
K050738000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K050738000FT FIBER OPTIC DELIVERY SYSTEMSFibertech GmbH2005-06-02GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
01858028005106PackageGS15In Commercial Distribution
02858028005105PackageGS12In Commercial Distribution
00858028005107PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
01858028005106018580280051061858028005106
02858028005105028580280051052858028005105
00858028005107008580280051078580280051070858028005107

GMDN Terms#

Term, Definition table
TermDefinition
Urogenital surgical laser system beam guide, reusableA flexible, probe-like device intended to be connected to a surgical laser system to invasively direct and deliver laser energy for urogenital surgical applications [e.g., to haemostatically cut, coagulate, and vaporize prostate tissue to treat benign prostatic hyperplasia (BPH), to treat bladder, urethral, and ureteral conditions (e.g., tumours, condylomas), to heat/ablate mucosal tissue to treat vaginal laxity]. It is designed to direct laser light from a laser generator to the surgical site and may be available in a variety of configurations/technologies (using, e.g., fibreoptic materials, specialized mirrors). This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
061766352
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816901023440Acquire MedQ-940-RT0966572023-05-26
02816901023448Acquire MedQ-940-RT0966572023-05-26
00816901023808Acquire MedQ-272-RT0966552022-11-05
00816901023815Acquire MedQ-550-RT0967902022-11-05
00816901023174Acquire MedDB-3000965022022-05-27
00816901022986Acquire MedQ-550-RTR0972762021-06-14
02816901022984Acquire MedQ-550-RTR0972762021-06-14
00816901022818LEONI™Q-272-RT0966552021-06-01
00816901022825Acquire MedQ-365-RT0966562021-06-01
00816901022832Acquire MedQ-940-RT0966572021-06-01
00816901022849Acquire MedQ-550-RT0967902021-06-01
00816901022856Acquire MedQ-200-RT0972032021-06-01
02816901022816LEONI™Q-272-RT0966552021-06-01
02816901022823Acquire MedQ-365-RT0966562021-06-01
01816901022831Acquire MedQ-940-RT0966572021-06-01
02816901022847Acquire MedQ-550-RT0967902021-06-01
01816901022855Acquire MedQ-200-RT0972032021-06-01
00816901021453NAQ-272-RT(LEONI Barrel)0955502016-11-24
00816901021620NAQ-150-RT0955202017-03-02
00816901021637NAQ-200-RT0955222017-03-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
08800020109460TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109477TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109484TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109491TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109507TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109514TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109521TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109538TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109545TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109552TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109651Edge HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109668Edge HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109675Edge HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109682Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109699Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109705Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109712Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109729Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109989FootswitchJeisys Medical Inc.GEX2026-07-16
08800020109996FootswitchJeisys Medical Inc.GEX2026-07-16
08800020110008FootswitchJeisys Medical Inc.GEX2026-07-16
08800020110275SMOOTHCOOL FilterJeisys Medical Inc.GEX2026-07-16
08800020110282SMOOTHCOOL FilterJeisys Medical Inc.GEX2026-07-16
08800020110299SMOOTHCOOL FilterJeisys Medical Inc.GEX2026-07-16