FDA.report

SUMMIT MEDICAL

Primary DI
10385640052013
Brand
SUMMIT MEDICAL
Company
Summit Medical, Inc.
Model
LS7012
Published
2021-09-03
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

Related Records

Product Codes

CodeName
BYYTube, Aspirating, Flexible, Connecting

Product Code Classifications

CodeDeviceSpecialtyClass
BYYTube, Aspirating, Flexible, ConnectingGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10385640052013PackageGS110In Commercial Distribution
00859898006119PreviousGS10
00385640052016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1038564005201310385640052013
00859898006119008598980061198598980061190859898006119
00385640052016003856400520163856400520160385640052016

GMDN Terms

TermDefinition
Suction/irrigation tubing, single-useA length of flexible noninvasive tube, typically made of synthetic polymer material(s), intended to interface between suction and/or irrigation devices (e.g., catheters, pumps, collection bottles) during a medical/surgical procedure (not dedicated to ophthalmic use); it might additionally be intended for use during reusable device reprocessing. The tubing may be provided in rolls from which required lengths are cut, or may be provided in predetermined lengths with connectors; it does not include additional associated items such as a clamp, spike, or bag (i.e., not a tubing set). This is a single-use device.

Sterilization Methods

Method

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
false
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 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
04250676716880ENT-single-use suction tubes, angledSpiggle & Theis Medizintechnik GmbHBYY2025-09-29
04250676716897ENT-single-use suction tubes, angledSpiggle & Theis Medizintechnik GmbHBYY2025-09-29
04250381814925ENT-single-use suction tubes, angledSpiggle & Theis Medizintechnik GmbHBYY2025-09-12
04250381814932ENT-single-use suction tubes, angledSpiggle & Theis Medizintechnik GmbHBYY2025-09-12
04250381814949ENT-single-use suction tubes, angledSpiggle & Theis Medizintechnik GmbHBYY2025-09-12
04250381814956ENT-single-use suction tubes, angledSpiggle & Theis Medizintechnik GmbHBYY2025-09-12
04250381814970ENT-single-use suction tubes, angledSpiggle & Theis Medizintechnik GmbHBYY2025-09-12
04250381814987ENT-single-use suction tubes, angledSpiggle & Theis Medizintechnik GmbHBYY2025-09-12
04250381814994ENT-single-use suction tubes, angledSpiggle & Theis Medizintechnik GmbHBYY2025-09-12
04250381815007ENT-single-use suction tubes, angledSpiggle & Theis Medizintechnik GmbHBYY2025-09-12
04250381815014ENT-single-use suction tubes, angledSpiggle & Theis Medizintechnik GmbHBYY2025-09-12
04250381815021ENT-single-use suction tubes, angledSpiggle & Theis Medizintechnik GmbHBYY2025-09-12
04250381815038ENT-single-use suction tubes, angledSpiggle & Theis Medizintechnik GmbHBYY2025-09-12
04250381815045ENT-single-use suction tubes, angledSpiggle & Theis Medizintechnik GmbHBYY2025-09-12
04250381815052ENT-single-use suction tubes, angledSpiggle & Theis Medizintechnik GmbHBYY2025-09-12
04250381815069ENT-single-use suction tubes, angledSpiggle & Theis Medizintechnik GmbHBYY2025-09-12
04250381815076ENT-single-use suction tubes, angledSpiggle & Theis Medizintechnik GmbHBYY2025-09-12
04250381815083ENT-single-use suction tubes, angledSpiggle & Theis Medizintechnik GmbHBYY2025-09-12
04250381815106ENT-single-use suction tubes, angledSpiggle & Theis Medizintechnik GmbHBYY2025-09-12
04250381815113ENT-single-use suction tubes, angledSpiggle & Theis Medizintechnik GmbHBYY2025-09-12
04250381815120ENT-single-use suction tubes, angledSpiggle & Theis Medizintechnik GmbHBYY2025-09-12
04250381815137ENT-single-use suction tubes, angledSpiggle & Theis Medizintechnik GmbHBYY2025-09-12
04250381815144ENT-single-use suction tubes, angledSpiggle & Theis Medizintechnik GmbHBYY2025-09-12
04250381815151ENT-single-use suction tubes, angledSpiggle & Theis Medizintechnik GmbHBYY2025-09-12
04250381815175ENT-single-use suction tubes, angledSpiggle & Theis Medizintechnik GmbHBYY2025-09-12
04250381815182ENT-single-use suction tubes, angledSpiggle & Theis Medizintechnik GmbHBYY2025-09-12
04250381815199ENT-single-use suction tubes, angledSpiggle & Theis Medizintechnik GmbHBYY2025-09-12
04250381815205ENT-single-use suction tubes, angledSpiggle & Theis Medizintechnik GmbHBYY2025-09-12
04250381815212ENT-single-use suction tubes, angledSpiggle & Theis Medizintechnik GmbHBYY2025-09-12
04250381815229ENT-single-use suction tubes, angledSpiggle & Theis Medizintechnik GmbHBYY2025-09-12