FDA.reportPublic FDA data

INSTRUSAFE

Primary DI
00385640005838
Brand
INSTRUSAFE
Company
Summit Medical, Inc.
Model
IN-7900-NF
Published
2021-05-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KCMDropper, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCMDropper, EntEar, Nose, Throat1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051157000
K133015000
K140289000
K141513000
K142630000
K142768000
K150540000
K151166000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051157000INSTRU-SAFE INSTRUMENT PROTECTION SYSTEMSMicromedics, Inc.2005-09-01KCT
K133015000INSTRU-SAFE INSTRUMENT PROTECTION SYSTEMSummit Medical, Inc.2014-03-13KCT
K140289000INSTRU-SAFE INSTRUMENT PROTECTION SYSTEMSummit Medical, Inc.2014-06-27KCT
K141513000INSTRU-SAFE INSTRUMENT PROTECTION SYSTEMSummit Medical, Inc.2014-12-15KCT
K142630000Instru-Safe Instrument Protection SystemSummit Medical, Inc.2014-12-23KCT
K142768000Instru-Safe Instrument Protection SystemSummit Medical, Inc.2015-05-29KCT
K150540000Instru-Safe Instrument Protection SystemSummit Medical, Inc.2015-06-22KCT
K151166000Instru-Safe Instrument Protection SystemSummit Medical, Inc.2015-08-18KCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00385640005838PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00385640005838003856400058383856400058380385640005838

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical instruments and related items for use during a clinical procedure; it might in addition be used during, but not dedicated to, reprocessing/sterilization procedures. It may be in the form of a shallow vessel with a raised rim, a deeper cassette-like device, or a flat or angled surface; it might include a lid. It may be designed to fit into other devices such as supply trolleys, storage systems and sterilizers, or designed to attach to a surgical/treatment table where it may be placed over the patient. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
965484699
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00385640072403Quintess®16572026-05-13
00385640072410Quintess®16582026-05-13
00385640091794INSTRUSAFEIN-2020-77532026-05-13
00385640091800INSTRUSAFEIN-2020-78032026-05-13
00385640091817INSTRUSAFEIN-2020-77512026-05-13
00385640091824INSTRUSAFEIN-2020-77932026-05-13
00385640091831INSTRUSAFEIN-2020-77042026-05-13
00385640091848INSTRUSAFEIN-2020-72672026-05-13
00385640091855INSTRUSAFEIN-2550-05-EN-0622026-05-13
00385640091862INSTRUSAFEIN-2550-05-EN-0632026-05-13
00385640091879INSTRUSAFEIN-2550-05-EN-0642026-05-13
00385640091886INSTRUSAFEIN-2550-05-EN-0652026-05-13
00385640091893INSTRUSAFEIN-2600-04-EN-0852026-05-13
00385640091909INSTRUSAFEIN-2020-76362026-05-13
00385640091916INSTRUSAFEIN-2020-76942026-05-13
00385640091923INSTRUSAFEIN-2020-77962026-05-13
00385640091930INSTRUSAFEIN-2020-78852026-05-13
00385640091947INSTRUSAFEIN-2020-78272026-05-13
00385640091954INSTRUSAFEIN-2020-78302026-05-13
00385640091961INSTRUSAFEIN-2020-78292026-05-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00384706050010AutoDropOWEN MUMFORD USA INCORPORATEDKCM2023-06-20
00384706150017AutoSqueezeOWEN MUMFORD USA INCORPORATEDKCM2023-06-20
00384706000015AutoDropOWEN MUMFORD USA INCORPORATEDKCM2023-06-07
00384706000022AutoDropOWEN MUMFORD USA INCORPORATEDKCM2023-06-07
00384706100012AutoSqueezeOWEN MUMFORD USA INCORPORATEDKCM2023-06-07
00076855100059ApexDrive Devilbiss HealthcareKCM2023-03-10
00635515992641ApexDrive Devilbiss HealthcareKCM2023-03-10
30076855100050ApexCOMPASS HEALTH BRANDS CORP.KCM2023-03-10
30635515992642ApexCOMPASS HEALTH BRANDS CORP.KCM2023-03-10
00635515992665ApexDrive Devilbiss HealthcareKCM2023-02-15
30041520876479ApexCOMPASS HEALTH BRANDS CORP.KCM2023-02-15
00076855005088ApexDrive Devilbiss HealthcareKCM2023-01-08
00076855700051ApexDrive Devilbiss HealthcareKCM2023-01-08
00076855700075ApexDrive Devilbiss HealthcareKCM2023-01-08
30076855700076ApexCOMPASS HEALTH BRANDS CORP.KCM2023-01-08
30076855700052ApexCOMPASS HEALTH BRANDS CORP.KCM2023-01-08
30076855005089ApexCOMPASS HEALTH BRANDS CORP.KCM2023-01-08
00076855601051ApexDrive Devilbiss HealthcareKCM2022-12-12
00076855605059ApexDrive Devilbiss HealthcareKCM2022-12-12
30076855601052ApexCOMPASS HEALTH BRANDS CORP.KCM2022-12-12
30076855605050ApexCOMPASS HEALTH BRANDS CORP.KCM2022-12-12
00385640005524INSTRUSAFESummit Medical, Inc.KCM2021-05-18
00385640005883INSTRUSAFESummit Medical, Inc.KCM2021-05-18
00385640005937INSTRUSAFESummit Medical, Inc.KCM2021-05-18
00385640005982INSTRUSAFESummit Medical, Inc.KCM2021-05-18
00385640006033INSTRUSAFESummit Medical, Inc.KCM2021-05-18
00385640013437INSTRUSAFESummit Medical, Inc.KCM2021-05-18
00385640005531INSTRUSAFESummit Medical, Inc.KCM2017-11-10