FDA.reportPublic FDA data

DISPOSABLE MICRO CANNULA FOR FILLER INJECTION

Primary DI
03701068804124
Brand
DISPOSABLE MICRO CANNULA FOR FILLER INJECTION
Company
AESTHETIC GROUP
Model
1-hole
Catalog number
MI2725KR
Device description
27gauge x 2,5 cm - 1-hole
Published
2022-04-29
Public version status
New
Distribution status
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
GEACannula, Surgical, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEACannula, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132353000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132353000SUCTION LIPOPLASTY ACCESSORIESInex2014-07-30QPB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03701068804131PackageGS120In Commercial Distribution
03701068804124PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03701068804131037010688041313701068804131
03701068804124037010688041243701068804124

GMDN Terms#

Term, Definition table
TermDefinition
Tissue injection cannulaA thin, sterile, semi-rigid or rigid metal tube intended to be inserted percutaneously for the injection of a substance into the cutaneous or subcutaneous layers. It is typically used for the administration of fillers [e.g., hyaluronic acid (HA)] to add volume to tissue for cosmetic or reconstructive purposes. The device is typically designed with a closed-off nose and a lateral hole at the distal tip, and a connector at the proximal end for attachment to a device that propels the injection substance. It is typically made of high-grade stainless steel. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius30 Degrees Celsius

Regulatory Flags#

DUNS number
260069352
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760173236206FAT HARVESTING CANNULACP32812HR2026-03-18
03760173236213FAT HARVESTING CANNULACP42812HR2026-03-18
03760173235339PACK LIPOFILLING MACROGRAFTPACK-MALT2026-02-04
03760173235360PACK LIPOFILLING MEDIUMGRAFTPACK-MELT2026-02-04
03760173235346PACK LIPOFILLING MACROGRAFTPACK-MALT2026-02-04
03760173235377PACK LIPOFILLING MEDIUMGRAFTPACK-MELT2026-02-04
03760173235391PACK LIPOFILLING MICROGRAFTPACK-MILT2026-02-04
03760173235421PACK LIPOFILLING NANOGRAFTPACK-NALT2026-02-04
03701068808054Kit lipofilling facePACK0002025-10-13
03701068808146Kit lipofilling facePACK-GOLD2020-12-14
03760173233694Infiltration kit1PACK001-BI2021-08-15
03760173235216PACK-EVOSKIN12024-09-05
03760173235292DISPOSABLE FAT HARVESTING CANNULA8-hole Arthrex labellingCP141508H2024-12-09
03701068800829DISPOSABLE TUMESCENT INFILTRATION CANNULA10-holeCI252502022-04-29
03701068803233DISPOSABLE MICRO CANNULA FOR FILLER INJECTION KIT1-holeKIT29/L2022-04-30
03701068804063DISPOSABLE MICRO CANNULA FOR FILLER INJECTION1-holeMI2525KR2022-04-29
03701068804094DISPOSABLE MICRO CANNULA FOR FILLER INJECTION1-holeMI2538KR2022-04-29
03701068804155DISPOSABLE MICRO CANNULA FOR FILLER INJECTION1-holeMI2750KR2022-04-30
03701068804186DISPOSABLE MICRO CANNULA FOR FILLER INJECTION1-holeMI3025KR2022-04-30
03701068805305DISPOSABLE MICRO CANNULA FOR FILLER INJECTION KIT1-holeMI2170KS2022-04-30

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00846338007348Working PortELLIQUENCE, LLCGEA2026-06-02
00846338007355Working PortELLIQUENCE, LLCGEA2026-06-02
00846338007362Working PortELLIQUENCE, LLCGEA2026-06-02
00846338005535Suction TubeELLIQUENCE, LLCGEA2026-06-01
00846338005542Suction TubeELLIQUENCE, LLCGEA2026-06-01
00810130456390Medco ManufacturingMedco Manufacturing LLCGEA2026-05-29
G453332414200PEAK MEDICALPeak Medical Distribution Inc.GEA2026-05-08
00840329837365BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.GEA2026-05-04
00840329837372BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.GEA2026-05-04
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G589DS23G301DermaSculptCosmoFranceGEA2026-04-13
G589DS23G401DermaSculptCosmoFranceGEA2026-04-13
G589DS23G501DermaSculptCosmoFranceGEA2026-04-13
G589DS25G401DermaSculptCosmoFranceGEA2026-04-13
G589DS25G501DermaSculptCosmoFranceGEA2026-04-13
G589DS27G251DermaSculptCosmoFranceGEA2026-04-13
G589DS27G401DermaSculptCosmoFranceGEA2026-04-13
G589DS27G501DermaSculptCosmoFranceGEA2026-04-13
G589DS30G251DermaSculptCosmoFranceGEA2026-04-13
10192253037906MonojectCardinal Health 200, LLCGEA2026-04-07
10192253037913MonojectCardinal Health 200, LLCGEA2025-10-10
10669808004008SoftFil® EasyGuideProllenium MedicalGEA2025-08-28
10669808004084SoftFil® PrecisionProllenium MedicalGEA2025-08-28
10192253003444ArgyleCardinal Health 200, LLCGEA2024-10-09
10192253003451ArgyleCardinal Health 200, LLCGEA2024-10-09