FDA.reportPublic FDA data

SoftFil® Precision

Primary DI
03760246600422
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
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760246600422PackageGS120In 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
261575410
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
03760246600057SoftFil® PrecisionCP2240/XL2023-02-16
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

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