FDA.reportPublic FDA data

DISPOSABLE FAT TRANSFER CANNULA

Primary DI
03760037736804
Brand
DISPOSABLE FAT TRANSFER CANNULA
Company
AESTHETIC GROUP
Model
1-hole
Catalog number
CPOE35150
Device description
3,5 mm x 15 cm - open end
Published
2022-04-29
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

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
03760037736804PackageGS110In Commercial Distribution
03760037733438PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760037736804037600377368043760037736804
03760037733438037600377334383760037733438

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
260069352
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
true
No natural rubber latex
false
Sterilization required before use
false

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
03701068804124DISPOSABLE MICRO CANNULA FOR FILLER INJECTION1-holeMI2725KR2022-04-29
03701068804155DISPOSABLE MICRO CANNULA FOR FILLER INJECTION1-holeMI2750KR2022-04-30
03701068804186DISPOSABLE MICRO CANNULA FOR FILLER INJECTION1-holeMI3025KR2022-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810130456420Medco ManufacturingMedco Manufacturing LLCGEA2026-06-05
00810130456437Medco ManufacturingMedco Manufacturing LLCGEA2026-06-05
00810130456444Medco ManufacturingMedco Manufacturing LLCGEA2026-06-05
00810130456451Medco ManufacturingMedco Manufacturing LLCGEA2026-06-05
00810130456468Medco ManufacturingMedco Manufacturing LLCGEA2026-06-05
00810130456475Medco ManufacturingMedco Manufacturing LLCGEA2026-06-05
00810130456482Medco ManufacturingMedco Manufacturing LLCGEA2026-06-05
00810130456505Medco ManufacturingMedco Manufacturing LLCGEA2026-06-05
00810130456413Medco ManufacturingMedco Manufacturing LLCGEA2026-06-02
00846338005436Working PortELLIQUENCE, LLCGEA2026-06-02
00846338007324Working PortELLIQUENCE, LLCGEA2026-06-02
00846338007331Working PortELLIQUENCE, LLCGEA2026-06-02
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
G589DS22G501DermaSculptCosmoFranceGEA2026-04-13
G589DS22G701DermaSculptCosmoFranceGEA2026-04-13
G589DS23G301DermaSculptCosmoFranceGEA2026-04-13
G589DS23G401DermaSculptCosmoFranceGEA2026-04-13
G589DS23G501DermaSculptCosmoFranceGEA2026-04-13
G589DS25G401DermaSculptCosmoFranceGEA2026-04-13
G589DS25G501DermaSculptCosmoFranceGEA2026-04-13
G589DS27G251DermaSculptCosmoFranceGEA2026-04-13
G589DS27G401DermaSculptCosmoFranceGEA2026-04-13