FDA.reportPublic FDA data

SUMMIT MEDICAL

Primary DI
00385640060127
Brand
SUMMIT MEDICAL
Company
Summit Medical, Inc.
Model
3-C-BTD-4X15
Published
2020-10-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00385640060127PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00385640060127003856400601273856400601270385640060127

GMDN Terms#

Term, Definition table
TermDefinition
Liposuction system cannula, reusableA 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 reusable 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
00385640094146INSTRUSAFEIN-2020-81562026-08-27
00385640094153INSTRUSAFEIN-2020-81182026-08-27
00385640094160INSTRUSAFEIN-2020-46252026-08-27
00385640094177INSTRUSAFEIN-2020-80712026-08-27
00385640094139INSTRUSAFEIN-2020-80552026-08-26
00385640094108INSTRUSAFEIN-2020-80222026-08-25
00385640094115INSTRUSAFEIN-2020-79442026-08-25
00385640094122INSTRUSAFEIN-2020-81962026-08-25
00385640094030INSTRUSAFEIN-2020-72762026-08-21
00385640094047INSTRUSAFEIN-2020-79432026-08-21
00385640094054INSTRUSAFEIN-2020-81902026-08-21
00385640094061INSTRUSAFEIN-8701-NF2026-08-21
00385640094078INSTRUSAFEIN-8701-R2026-08-21
00385640094085INSTRUSAFEIN-8701-TF2026-08-21
00385640094016INSTRUSAFEIN-2020-80652026-08-19
00385640094023INSTRUSAFEIN-2020-80482026-08-19
00385640093972INSTRUSAFEIN-2020-78952026-08-18
00385640093989INSTRUSAFEIN-2020-81052026-08-18
00385640094009INSTRUSAFEIN-2020-80542026-08-18
00385640093941INSTRUSAFEIN-2020-78962026-08-14

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