FDA.reportPublic FDA data

DISPOSABLE MICRO CANNULA FOR FILLER INJECTION KIT

Primary DI
03701068805435
Brand
DISPOSABLE MICRO CANNULA FOR FILLER INJECTION KIT
Company
AESTHETIC GROUP
Model
1-hole
Catalog number
MI2170KE
Device description
21gauge x 7 cm - 1-hole
Published
2022-04-30
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
03701068805435PackageGS120In Commercial Distribution
03701068805428PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03701068805435037010688054353701068805435
03701068805428037010688054283701068805428

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
false
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
00810130456710Medco ManufacturingMedco Manufacturing LLCGEA2026-07-23
00810130456727Medco ManufacturingMedco Manufacturing LLCGEA2026-07-23
00810130456734Medco ManufacturingMedco Manufacturing LLCGEA2026-07-23
00810130456741Medco ManufacturingMedco Manufacturing LLCGEA2026-07-23
03661219357063DELACROIX-CHEVALIERLANDANGERGEA2026-07-23
03661219357070DELACROIX-CHEVALIERLANDANGERGEA2026-07-23
03661219357087DELACROIX-CHEVALIERLANDANGERGEA2026-07-23
03661219357094DELACROIX-CHEVALIERLANDANGERGEA2026-07-23
00190776403812MillenniumAvalign Technologies, Inc.GEA2026-07-21
00190776403249MillenniumAvalign Technologies, Inc.GEA2026-07-19
00810220800485Adler Instrument CompanyAdler, Inc.GEA2026-07-17
10810128462782StayPort™ Cannula 5 mm x 7 cmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONGEA2026-07-16
10810128462799StayPort™ Cannula 5 mm x 9 cmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONGEA2026-07-16
10810128462805StayPort™ Cannula 7 mm x 7 cmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONGEA2026-07-16
10810128462812StayPort™ Cannula 7 mm x 9 cmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONGEA2026-07-16
10810128462829StayPort™ Cannula 9 mm x 7 cmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONGEA2026-07-16
10810128462836StayPort™ Cannula 9 mm x 9 cmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONGEA2026-07-16
10810128462843StayPort™ Cannula 9 mm x 11 cmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONGEA2026-07-16
10810128462850StayPort™ Cannula 9 mm x 13 cmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONGEA2026-07-16
B382SD2303290Surgical DirectSurgical Direct, Inc.GEA2026-07-14
B382SD303490Surgical DirectSurgical Direct, Inc.GEA2026-07-14
00810130456574Medco ManufacturingMedco Manufacturing LLCGEA2026-07-09
00810130456581Medco ManufacturingMedco Manufacturing LLCGEA2026-07-09
00810130456598Medco ManufacturingMedco Manufacturing LLCGEA2026-07-09
00810130456604Medco ManufacturingMedco Manufacturing LLCGEA2026-07-09
00810130456611Medco ManufacturingMedco Manufacturing LLCGEA2026-07-09
20192253036821MonojectCardinal Health 200, LLCGEA2026-07-09
00850083275709Intrace USAPILOTIS TECH LLCGEA2026-07-03
00810130456550Medco ManufacturingMedco Manufacturing LLCGEA2026-06-26
00810130456567Medco ManufacturingMedco Manufacturing LLCGEA2026-06-26