FDA.reportPublic FDA data

MICROFILL 22G x 50mm

Primary DI
10669808002004
Brand
MICROFILL 22G x 50mm
Company
Prollenium Medical
Model
PN56041
Device description
Sterile, single-use, stainless-steel cannula. Dimensions 22G x 50mm.
Published
2020-06-22
Public version status
Update
Distribution status
Not 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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10669808002004PrimaryGS10
00669808002007Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1066980800200410669808002004
00669808002007006698080020076698080020070669808002007

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 Temperature2 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
247326606
Device count
100
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10669808005791Revanesse Gel PackPN998022025-05-22
10669808004008SoftFil® EasyGuideCEGS2550U2025-08-28
10669808004084SoftFil® PrecisionCP2550U2025-08-28
10669808002141SoftFil® EasyGuideCEGS2550U2025-08-28
10669808002325SoftFil® PrecisionCP2550U2025-08-28
10669808002011MICROFILL 22G x 70mmPN560422020-06-22
10669808002028MICROFILL 25G x 38mmPN560432020-06-22
10669808002035MICROFILL 25G x 50mmPN560442020-06-22
10669808002042MICROFILL 27G x 25mmPN560452020-06-22
10669808002059MICROFILL 27G x 38mmPN560462020-06-22
10669808002066MICROFILL 27G x 50mmPN560472020-06-22
10669808002073MICROFILL 30G x 25mmPN560482020-06-22
10669808002080MICROFILL 30G x 40mmPN560492020-06-22
10669808003032Revanesse Lips+ with Lidocaine 1.2 mL401492021-05-17
10669808001007Revanesse Versa 1.0mL400812020-12-15
10669808001014Revanesse Versa+ with Lidocaine 1.0 mL400822020-12-15
10669808001021Revanesse Versa 1.2 mL400892020-12-15
10669808002394SoftFil® EasyGuideCEGS2250U2022-08-11
10669808002400SoftFil® EasyGuideCEGS2330U2022-08-11
10669808002417SoftFil® EasyGuideCEGS2350U2022-08-11

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