FDA.reportPublic FDA data

SoftFil® Precision

Primary DI
10669808002578
Brand
SoftFil® Precision
Company
Prollenium Medical
Model
CP2290U
Device description
SoftFil® Precision are sterile and single use injection kits containing:- 1 stainless steel pre-hole needle in its protective cap,- 1 stainless steel, graduated blunt-tip needle (micro-cannula) 22G x 90 mm in its protective cap.
Published
2022-08-11
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10669808002578PrimaryGS10
10669808002271Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1066980800257810669808002578
1066980800227110669808002271

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
247326606
Device count
20
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
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
10669808002004MICROFILL 22G x 50mmPN560412020-06-22
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840329838232BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.GEA2026-06-08
00840329838249BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.GEA2026-06-08
G4533312250PEAK MEDICALPeak Medical Distribution Inc.GEA2026-06-08
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