FDA.reportPublic FDA data

SoftFil® Precision

Primary DI
03760246600057
Brand
SoftFil® Precision
Company
SOFT MEDICAL AESTHETICS
Model
CP2240/XL
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 40 mm in its protective cap.
Published
2023-02-16
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
03760246600422PackageGS120Not in Commercial Distribution
03760246600057PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760246600422037602466004223760246600422
03760246600057037602466000573760246600057

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.

Regulatory Flags#

DUNS number
261575410
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760246600064SoftFil® PrecisionCP2250/XL2023-02-16
03760246600088SoftFil® PrecisionCP2290/XL2023-02-16
03760246600095SoftFil® PrecisionCP2330/XL2023-02-16
03760246600101SoftFil® PrecisionCP2350/XL2023-02-16
03760246600118SoftFil® PrecisionCP2530/XL2023-02-16
03760246600125SoftFil® PrecisionCP2540/XL2023-02-16
03760246600132SoftFil® PrecisionCP2550/XL2023-02-16
03760246600149SoftFil® PrecisionCP2560/XL2023-02-16
03760246600156SoftFil® PrecisionCP2613/XL2023-02-16
03760246600163SoftFil® PrecisionCP2725/XL2023-02-16
03760246600170SoftFil® PrecisionCP2740/XL2023-02-16
03760246600194SoftFil® PrecisionCP3025/XL2023-02-16
03760246600217SoftFil® ClassicCS1870/N2023-02-16
03760246600590SoftFil® ClassicCS2240/L2023-02-16
03760246600606SoftFil® ClassicCS2250/L2023-02-16
03760246600613SoftFil® ClassicCS2270/L2023-02-16
03760246600620SoftFil® ClassicCS2290/L2023-02-16
03760246600637SoftFil® ClassicCS2550/L2023-02-16
03760246600644SoftFil® ClassicCS2740/L2023-02-16
03760246600651SoftFil® ClassicCS3025/L2023-02-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810130456789Medco ManufacturingMedco Manufacturing LLCGEA2026-08-25
00810130456796Medco ManufacturingMedco Manufacturing LLCGEA2026-08-25
00810130456819Medco ManufacturingMedco Manufacturing LLCGEA2026-08-25
00190776419066MillenniumAvalign Technologies, Inc.GEA2026-08-23
00190776419639MillenniumAvalign Technologies, Inc.GEA2026-08-23
00850012846741JNW URTRACLSI Solutions, Inc.GEA2026-08-21
00884450681329Preston™Merit Medical Systems, Inc.GEA2026-08-21
00884450681336Preston™Merit Medical Systems, Inc.GEA2026-08-21
00884450681343Preston™Merit Medical Systems, Inc.GEA2026-08-21
00884450681350Preston™Merit Medical Systems, Inc.GEA2026-08-21
04054462902583evonosevonos GmbH & Co. KGGEA2026-08-21
04054462902590evonosevonos GmbH & Co. KGGEA2026-08-21
04054462902606evonosevonos GmbH & Co. KGGEA2026-08-21
04054462902613evonosevonos GmbH & Co. KGGEA2026-08-21
04054462902620evonosevonos GmbH & Co. KGGEA2026-08-21
04054462902637evonosevonos GmbH & Co. KGGEA2026-08-21
04054462902644evonosevonos GmbH & Co. KGGEA2026-08-21
04054462902651evonosevonos GmbH & Co. KGGEA2026-08-21
04054462902668evonosevonos GmbH & Co. KGGEA2026-08-21
00190776417062MillenniumAvalign Technologies, Inc.GEA2026-08-18
00190776407506MillenniumAvalign Technologies, Inc.GEA2026-07-31
00840329838409BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.GEA2026-07-30
00840329838416BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.GEA2026-07-30
00840329838430BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.GEA2026-07-30
00840329838454BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.GEA2026-07-30
00840329838515BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.GEA2026-07-30
00810130456710Medco ManufacturingMedco Manufacturing LLCGEA2026-07-23
00810130456727Medco ManufacturingMedco Manufacturing LLCGEA2026-07-23
00810130456734Medco ManufacturingMedco Manufacturing LLCGEA2026-07-23
00810130456741Medco ManufacturingMedco Manufacturing LLCGEA2026-07-23