FDA.reportPublic FDA data

N/A

Primary DI
08809447651781
Brand
N/A
Company
Lutronic Corporation
Model
TIP A-49 1 ea
Device description
INFINI MFR TIP A-49 1 ea(MFR 49 Tip)
Published
2016-11-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
8809447651774PackageGS11In Commercial Distribution
08809447651781PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
8809447651774088094476517748809447651774
08809447651781088094476517818809447651781

GMDN Terms#

Term, Definition table
TermDefinition
Radio-frequency skin surface treatment systemAn assembly of devices designed to apply radio-frequency (RF) energy to heat the skin surface for ablation, coagulation, and tightening of the skin’s outer later (stratum corneum) for aesthetic skin resurfacing. It primarily consists of a mains electricity (AC-powered) control unit to produce and regulate the RF energy, and a connected bipolar RF applicator (handpiece) to deliver the RF energy to the skin surface; the applicator may include vacuum to facilitate its coupling with the skin.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity30 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Handling Environment Temperature20 Degrees Celsius30 Degrees Celsius
Storage Environment Humidity30 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
215-205-2219jvojir@lutronic.com

Regulatory Flags#

DUNS number
688282516
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809447650883INFINIINFINI MFR G U110V2016-09-09
08809447650982N/AMFR Handpiece 2016-09-09
08809447651019N/AHandpiece cradle2016-09-09
08809447651675N/A830&590nm Head2016-09-09
08809447651699Healite IIHealite Body Assy2016-09-09
08809447651729N/AArm2016-09-09
08809447652375INFINI49 pin Tip (Standard) 1 ea2019-01-15
08809447652399INFINI16 pin Tip (Optional) 1 ea2019-01-15
08809447651033N/AMFR 49 TIP II 1 ea2016-09-09
08809447651064N/ATIP A-16 1 ea2016-09-09
08809447651170N/AINFINI Operator's Manual USA2016-09-09
08809447651712N/AManual2016-09-09
08809447652122N/AGoggle ASSY (For patient)2018-08-06
08809447652139N/APatient Goggle2018-08-06
08809447652351INFINI49 pin (Enhanced) 1 ea2019-01-15
08809447657424MOSAIC 3DPill Tip Package2025-11-28
08809447657745XERFXERF EFFECTOR 60(600)2025-11-28
08809447657011MOSAIC 3DMOSAIC 3D2025-11-28
08809447657370MOSAIC 3DSapphire Tip Package2025-11-28
08809447657387MOSAIC 3DRoller Tip Package2025-11-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B108499AP1MRA1MUS00Large applicatorBTL INDUSTRIES LIMITEDGEI2026-10-20
B108499AP1MRA2MUS00Small applicatorBTL INDUSTRIES LIMITEDGEI2026-10-20
B108499AP1MRA45MUS00Edge applicatorsBTL INDUSTRIES LIMITEDGEI2026-10-20
B108499PO1MUS00BTL-499-1BTL INDUSTRIES LIMITEDGEI2026-10-20
00190776435288MillenniumAvalign Technologies, Inc.GEI2026-10-19
B354OSCVORTH80Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH81Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH82Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH83Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH84Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH85Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH89Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
00860016247000Super PencilRF KINETICS LLCGEI2026-10-17
00860016247017Super PencilRF KINETICS LLCGEI2026-10-17
00860016247024Super PencilRF KINETICS LLCGEI2026-10-17
00860016247031Super PencilRF KINETICS LLCGEI2026-10-17
00841019124017KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124024KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124048KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124079KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124086KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124093KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124109KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124116KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124123KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124130KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
10381780533276Codman®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEI2026-10-15
10381780533283Codman®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEI2026-10-15
00190776435028MillenniumAvalign Technologies, Inc.GEI2026-10-14
00190776434878MillenniumAvalign Technologies, Inc.GEI2026-10-13