FDA.reportPublic FDA data

Evulse

Primary DI
10851314007486
Brand
Evulse
Company
Innovative Med
Model
LTM-Evu D 5-15
Device description
LTM EVULSE, DOUBL, 500 & 1500
Published
2021-06-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MDMInstrument, Manual, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10851314007486PackageGS15In Commercial Distribution
00851314007489PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085131400748610851314007486
00851314007489008513140074898513140074890851314007489

GMDN Terms#

Term, Definition table
TermDefinition
Suction system filter, tissue, sterileA sterile device intended to be fitted into a suction system bottle/canister to separate tissue from the aspirate during a surgical procedure; the tissue may be subsequently used for various diagnostic/therapeutic purposes (e.g., autologous fat tissue transfer, histological/pathological analysis). It is a meshed flat or tubular piece; accessory components (e.g., container sealing rings, tubing, filter housing) may be included. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
949-458-1897BENK@IMIBEAUTY.COM

Regulatory Flags#

DUNS number
928308407
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true
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
00851314007434EvulseLTM-Evu S 1500PG-MBOOST-15002021-06-02
00851314007465EvulseLTM-Evu S 1000PG-MBOOST-10002021-06-02
00851314007489EvulseLTM-Evu D 5-152021-06-02
00851314007472EvulseLTM-Evu S 500PG-MBOOST-5002021-06-02
00851314007519A.T.T.SIM-ATTS-C2-EXT2024-08-21
00851314007557A.T.T.S.IM-ATTS-C2LD-SS2025-01-15
00851314007502A.T.T.SIM-ATTS-CS-D2024-08-21
00851314007076A.T.T.S.ATTS-C2IM-ATTS-C22016-09-09
00851314007083A.T.T.SATTS-C75IM-ATTS-C752016-09-12
00851314007007Phantom2550-2IM-K2550-22016-09-19
00851314007014Phantom2540-1IM-K2540-12016-09-19
00851314007038Phantom2540-2IM-K2540-22016-09-19
00851314007045Phantom2550-1IM-K2550-12016-09-19
00851314007052K-Pump1000-0031IM-1000-00312016-09-12
00851314007212KMI IMI Group19-00992017-07-18
00851314007410A.T.T.S SILO19-79002020-05-19
00851314007397A.T.T.SATTS-C2LD-DIM-ATTS-C2LD-D2020-03-06
00851314007403A.T.T.SATTS-C2-BDIM-ATTS-C2-BD2020-03-06
00851314007281A.T.T.S.IM-FI2019-02-04
00851314007205KMI IMI GROUPSFRT2017-07-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506091209ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-03
00810130456406Medco ManufacturingMedco Manufacturing LLCMDM2026-06-02
00846338007126Endiscope and accessoriesELLIQUENCE, LLCMDM2026-06-02
00846338005429DilatorELLIQUENCE, LLCMDM2026-06-01
06932503510219Pulmonary Hydro-Slide GuidewireMicro-Tech (Nanjing) Co., Ltd.MDM2026-05-29
06932503510226Pulmonary Hydro-Slide GuidewireMicro-Tech (Nanjing) Co., Ltd.MDM2026-05-29
B356KE392100American MedicalsAmerican MedicalsMDM2026-05-29
B356KE396100American MedicalsAmerican MedicalsMDM2026-05-29
08800042700102Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042700140Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042700256Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042700270Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042700287Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042700300Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042700317Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042700324Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042700386Artisential Needle HolderLIVSMEDMDM2026-04-29
08800042700393Artisential Needle HolderLIVSMEDMDM2026-04-29
08800042700416Artisential Needle HolderLIVSMEDMDM2026-04-29
08800042700423Artisential Needle HolderLIVSMEDMDM2026-04-29
08800042700843Artisential Precise Needle HolderLIVSMEDMDM2026-04-29
08800042700850Artisential Precise Needle HolderLIVSMEDMDM2026-04-29
08800042700874Artisential Precise Needle HolderLIVSMEDMDM2026-04-29
08800042700881Artisential Precise Needle HolderLIVSMEDMDM2026-04-29
08800042700997Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042701017Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042701031Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042701048Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042701062Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042701086Artisential Maryland DissectorLIVSMEDMDM2026-04-29