FDA.reportPublic FDA data

STERiGLIDE TM

Primary DI
14580708061907
Brand
STERiGLIDE TM
Company
TSK LABORATORY, JAPAN
Model
SGC-27038
Device description
CANNULA
Published
2023-04-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
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
14580708061907PackageGS1180In Commercial Distribution
04580708061900PrimaryGS10
04571225316307Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1458070806190714580708061907
04580708061900045807080619004580708061900
04571225316307045712253163074571225316307

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length38Millimeter
Outer Diameter0.4Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690646096
Device count
4
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
04580708068527STERiJECT TMPRE-25013I2026-01-15
04580708068534STERiJECT TMPRE-25013I2026-01-15
14580708068524STERiJECT TMPRE-25013I2026-01-15
24580708068538STERiJECT TMPRE-25013I2026-01-15
04580708067445STERiJECT TMLDS-27006I2025-08-18
14580708067442STERiJECT TMLDS-27006I2025-08-18
04571225317625STERiJECT TMHPC-31013E2024-06-11
14571225317622STERiJECT TMHPC-31013E2024-06-11
14571225314157STERiJECT TMHPC-27013I2024-06-10
14571225314218STERiJECT TMHPC-30013I2024-06-10
04571225314105STERiJECT TMHPC-23013I2024-06-10
04571225314112STERiJECT TMHPC-23013I2024-06-10
04571225314198STERiJECT TMHPC-27019I2024-06-10
04571225314204STERiJECT TMHPC-27019I2024-06-10
04571225314235STERiJECT TMHPC-30013I2024-06-10
04571225317779STERiJECT TMHPC-23013I2024-06-10
04571225317793STERiJECT TMHPC-27013I2024-06-10
04571225317809STERiJECT TMHPC-27019I2024-06-10
04571225317816STERiJECT TMHPC-29010E2024-06-10
04571225317823STERiJECT TMHPC-29013E2024-06-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
G589DS27G501DermaSculptCosmoFranceGEA2026-04-13
G589DS30G251DermaSculptCosmoFranceGEA2026-04-13
10192253037906MonojectCardinal Health 200, LLCGEA2026-04-07
10192253037913MonojectCardinal Health 200, LLCGEA2025-10-10
10669808004008SoftFil® EasyGuideProllenium MedicalGEA2025-08-28
10669808004084SoftFil® PrecisionProllenium MedicalGEA2025-08-28
10192253003444ArgyleCardinal Health 200, LLCGEA2024-10-09
10192253003451ArgyleCardinal Health 200, LLCGEA2024-10-09