FDA.reportPublic FDA data

INSTRUSAFE

Primary DI
00385640061292
Brand
INSTRUSAFE
Company
Summit Medical, Inc.
Model
IN-2020-4273
Published
2020-10-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesGeneral Hospital2

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
00385640061292PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00385640061292003856400612923856400612920385640061292

GMDN Terms#

Term, Definition table
TermDefinition
Instrument trayA container intended to provide a suitable platform for containing many medical/surgical instruments and related items during a clinical procedure; it might in addition be used during reprocessing/sterilization procedures, however it is not dedicated to reprocessing/sterilization. It is typically designed as a shallow vessel with a raised rim, or as a deeper cassette-like device, and it might include a lid. It is designed to fit into other devices such as supply trolleys, storage systems and sterilizers. 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
00385640095167INSTRUSAFEIN-2020-77352026-10-16
00385640095082INSTRUSAFEIN-2020-82852026-10-15
00385640095099INSTRUSAFEIN-2020-81252026-10-15
00385640095105INSTRUSAFEIN-2020-82152026-10-15
00385640095112INSTRUSAFEIN-2020-79102026-10-15
00385640095129INSTRUSAFEIN-2020-82582026-10-15
00385640095136INSTRUSAFEIN-2020-80112026-10-15
00385640095143INSTRUSAFEIN-2300-05-EN-1522026-10-15
00385640095150INSTRUSAFEIN-2300-05-EN-1532026-10-15
00385640095051INSTRUSAFEIN-2020-81722026-10-14
00385640095068INSTRUSAFEIN-2020-82842026-10-14
00385640095075INSTRUSAFEIN-2020-81232026-10-14
00385640095044INSTRUSAFEIN-2020-82382026-10-13
00385640094887INSTRUSAFEIN-2020-81602026-10-09
00385640094894INSTRUSAFEIN-2020-74472026-10-09
00385640094870INSTRUSAFEIN-2020-81062026-10-08
00385640094832INSTRUSAFEIN-2020-82832026-10-07
00385640094849INSTRUSAFEIN-2020-81002026-10-07
00385640094856INSTRUSAFEIN-2020-81662026-10-07
00385640094863INSTRUSAFEIN-2020-81112026-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00385640095167INSTRUSAFESummit Medical, Inc.KCT2026-10-16
10886982312327NASynthes GmbHKCT2026-10-16
10886982346704VOLTSynthes GmbHKCT2026-10-16
10886982346735VOLTSynthes GmbHKCT2026-10-16
10886982363282NASynthes GmbHKCT2026-10-16
10886982363299NASynthes GmbHKCT2026-10-16
10886982363305NASynthes GmbHKCT2026-10-16
10886982363312NASynthes GmbHKCT2026-10-16
00385640095082INSTRUSAFESummit Medical, Inc.KCT2026-10-15
00385640095099INSTRUSAFESummit Medical, Inc.KCT2026-10-15
00385640095105INSTRUSAFESummit Medical, Inc.KCT2026-10-15
00385640095112INSTRUSAFESummit Medical, Inc.KCT2026-10-15
00385640095129INSTRUSAFESummit Medical, Inc.KCT2026-10-15
00385640095136INSTRUSAFESummit Medical, Inc.KCT2026-10-15
00385640095143INSTRUSAFESummit Medical, Inc.KCT2026-10-15
00385640095150INSTRUSAFESummit Medical, Inc.KCT2026-10-15
00724995239909V. MuellerSteris CorporationKCT2026-10-15
00724995239916V. MuellerSteris CorporationKCT2026-10-15
00724995239923V. MuellerSteris CorporationKCT2026-10-15
00724995239930V. MuellerSteris CorporationKCT2026-10-15
00724995239947V. MuellerSteris CorporationKCT2026-10-15
00724995240660V. MuellerSteris CorporationKCT2026-10-15
00724995240677V. MuellerSteris CorporationKCT2026-10-15
00724995240684V. MuellerSteris CorporationKCT2026-10-15
00724995240691V. MuellerSteris CorporationKCT2026-10-15
00724995240707V. MuellerSteris CorporationKCT2026-10-15
00724995241025V. MuellerSteris CorporationKCT2026-10-15
00724995241049V. MuellerSteris CorporationKCT2026-10-15
00724995241056V. MuellerSteris CorporationKCT2026-10-15
00724995241063V. MuellerSteris CorporationKCT2026-10-15