FDA.reportPublic FDA data

SUMMIT MEDICAL

Primary DI
00385640060936
Brand
SUMMIT MEDICAL
Company
Summit Medical, Inc.
Model
3-C-OP-3X30
Published
2020-10-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00385640060936PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00385640060936003856400609363856400609360385640060936

GMDN Terms#

Term, Definition table
TermDefinition
Liposuction system cannula, single-useA rigid tube that functions as a component of a lipectomy suction system and designed specifically for percutaneous insertion into body fat deposits for the aspiration of fat during liposuction/lipoplasty. The device may also be used to infiltrate the operative site with a solution during the procedure, which is then aspirated. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
965484699
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00385640095327INSTRUSAFEIN-2020-83042026-10-26
00385640095334INSTRUSAFEIN-2020-82422026-10-26
00385640095303INSTRUSAFEIN-2020-83002026-10-23
00385640095310INSTRUSAFEIN-2020-78492026-10-23
00385640095297INSTRUSAFEIN-2020-82162026-10-22
00385640095211INSTRUSAFEIN-3030-03262026-10-21
00385640095228INSTRUSAFEIN-2020-82942026-10-21
00385640095235INSTRUSAFEIN-2300-05-EN-1542026-10-21
00385640095242INSTRUSAFEIN-2300-05-EN-1552026-10-21
00385640095259INSTRUSAFEIN-2300-05-EN-1562026-10-21
00385640095266INSTRUSAFEIN-2020-80122026-10-21
00385640095273INSTRUSAFEIN-2300-05-EN-1502026-10-21
00385640095280INSTRUSAFEIN-2300-05-EN-1512026-10-21
00385640095174INSTRUSAFEIN-2020-80252026-10-20
00385640095181INSTRUSAFEIN-2020-82952026-10-20
00385640095198INSTRUSAFEIN-2020-82282026-10-20
00385640095204INSTRUSAFEIN-2020-82732026-10-20
00385640095167INSTRUSAFEIN-2020-77352026-10-16
00385640095082INSTRUSAFEIN-2020-82852026-10-15
00385640095099INSTRUSAFEIN-2020-81252026-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810130456901Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130456918Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130456925Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130456932Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130456949Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130456956Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130456963Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130456970Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130456987Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130456994Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457007Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457014Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457021Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457038Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457045Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457052Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457069Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457076Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457083Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457106Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457113Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457120Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457137Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457144Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457168Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457175Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457182Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457212Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457229Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457236Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23