FDA.report

SUMMIT MEDICAL

Primary DI
10385640054918
Brand
SUMMIT MEDICAL
Company
SUMMIT MEDICAL, INC.
Model
LS7020
Published
2021-03-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
GEACannula, Surgical, General & Plastic Surgery
KDQBottle, Collection, Vacuum

Product Code Classifications

CodeDeviceSpecialtyClass
GEACannula, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1
KDQBottle, Collection, VacuumGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10385640054918PackageGS110In Commercial Distribution
00859898006386PreviousGS10
00385640054911PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1038564005491810385640054918
00859898006386008598980063868598980063860859898006386
00385640054911003856400549113856400549110385640054911

GMDN Terms

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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
965484699
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00385640091183INSTRUSAFEIN-2020-75582026-03-24
00385640091190INSTRUSAFEIN-3030-02542026-03-24
00385640091206INSTRUSAFEIN-3030-02532026-03-24
00385640091152INSTRUSAFEIN-2020-76872026-03-23
00385640091169INSTRUSAFEIN-2020-77092026-03-23
00385640091176INSTRUSAFEIN-2020-77212026-03-23
00385640091114INSTRUSAFEIN-2020-75572026-03-20
00385640091121INSTRUSAFEIN-2020-75562026-03-20
00385640091138INSTRUSAFEIN-2020-76112026-03-20
00385640091145INSTRUSAFEIN-2020-75882026-03-20
00385640090872INSTRUSAFEIN-2300-10-EN-1012026-03-19
00385640090889INSTRUSAFEIN-2300-10-EN-1022026-03-19
00385640090896INSTRUSAFEIN-2300-10-EN-1032026-03-19
00385640090902INSTRUSAFEIN-2300-10-EN-1042026-03-19
00385640090919INSTRUSAFEIN-2300-10-EN-1052026-03-19
00385640090926INSTRUSAFEIN-2300-10-EN-1062026-03-19
00385640090933INSTRUSAFEIN-2300-10-EN-1072026-03-19
00385640090940INSTRUSAFEIN-2300-10-EN-1082026-03-19
00385640090957INSTRUSAFEIN-2300-10-EN-1092026-03-19
00385640090964INSTRUSAFEIN-2300-10-EN-1102026-03-19

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
G453CFK1000PEAK MEDICALPeak Medical Distribution Inc.GEA2026-03-23
G453AR130PEAK MEDICALPeak Medical Distribution Inc.GEA2026-03-11
00810130456109Medco ManufacturingMedco Manufacturing LLCGEA2026-02-27
00850027043821Precision Medical Inc.Precision Medical, Inc.KDQ2026-02-25
00850027043838Precision Medical Inc.Precision Medical, Inc.KDQ2026-02-25
00850080243145T-Han Delivery SystemBONE SOLUTIONS, INC.GEA2026-02-13
00850080243152T-Han Delivery SystemBONE SOLUTIONS, INC.GEA2026-02-13
00850080243169T-Han Delivery SystemBONE SOLUTIONS, INC.GEA2026-02-13
00650862199109AtriumAtrium Medical CorporationKDQ2026-02-10
20650862199158AtriumAtrium Medical CorporationKDQ2026-02-10
20650862199189AtriumAtrium Medical CorporationKDQ2026-02-10
06970462546849Stone CollectorShenzhen HugeMed Medical Technical Development Co., Ltd.KDQ2026-02-10
16970462546853Stone CollectorShenzhen HugeMed Medical Technical Development Co., Ltd.KDQ2026-02-10
10884389968109MEDLINEMEDLINE INDUSTRIES, INC.KDQ2026-01-29
10884389968123MEDLINEMEDLINE INDUSTRIES, INC.KDQ2026-01-29
10888277143029MEDLINEMEDLINE INDUSTRIES, INC.KDQ2026-01-29
10888277143517MEDLINEMEDLINE INDUSTRIES, INC.KDQ2026-01-29
20860002896964TalarusCannuflow, Inc.GEA2026-01-28
00860014577536GROWNSYOak Tech LLCKDQ2026-01-28
00860014577543GROWNSYOak Tech LLCKDQ2026-01-28
04058749082937NAFehling Instruments GmbH & Co. KGGEA2026-01-28
00810477022272AMPLIMAMPLIM, LLCKDQ2026-01-16
00810477022289AMPLIMAMPLIM, LLCKDQ2026-01-16
00840329836795N/ABLACK & BLACK SURGICAL, INC.GEA2026-01-16
00840329837013N/ABLACK & BLACK SURGICAL, INC.GEA2026-01-16
07630542741012CannulaMedacta International SAGEA2026-01-16
07630542741029CannulaMedacta International SAGEA2026-01-16
07630542741036CannulaMedacta International SAGEA2026-01-16
07630542746499CannulaMedacta International SAGEA2026-01-16
07630542746505CannulaMedacta International SAGEA2026-01-16