FDA.reportPublic FDA data

INSTRUSAFE

Primary DI
00385640071895
Brand
INSTRUSAFE
Company
Summit Medical, Inc.
Model
IN-8914-TF
Published
2022-08-24
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
K210836000

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
K210836000InstruSafe Instrument Protection SystemSummitt Medical, LLC2021-11-30KCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00385640071895PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00385640071895003856400718953856400718950385640071895

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing clinical instruments (typically endoscopes or surgical instruments) for use during a clinical procedure; it might in addition be used during, but not dedicated to, reprocessing/sterilization procedures. It is typically 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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00385640094795INSTRUSAFEIN-2020-80202026-10-06
00385640094801INSTRUSAFEOM-1002-BM2026-10-06
00385640094818INSTRUSAFEIN-2020-79752026-10-06
00385640094825INSTRUSAFEIN-2020-80332026-10-06
00385640094726INSTRUSAFEIN-2020-81642026-10-05
00385640094733INSTRUSAFEIN-2020-80132026-10-05
00385640094740INSTRUSAFEIN-2020-82242026-10-05
00385640094757INSTRUSAFEOM-2001-LS2026-10-05
00385640094764INSTRUSAFEIN-2020-80142026-10-05
00385640094771INSTRUSAFEIN-2020-82012026-10-05
00385640094788INSTRUSAFEIN-2020-82542026-10-05
00385640094689INSTRUSAFEIN-2020-82652026-10-01
00385640094696INSTRUSAFEIN-2020-81582026-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00643169236967n/aMEDTRONIC SOFAMOR DANEK, INC.KCT2026-10-11
00643169236974n/aMEDTRONIC SOFAMOR DANEK, INC.KCT2026-10-11
00643169236981n/aMEDTRONIC SOFAMOR DANEK, INC.KCT2026-10-11
00385640094887INSTRUSAFESummit Medical, Inc.KCT2026-10-09
00385640094894INSTRUSAFESummit Medical, Inc.KCT2026-10-09
00190776436193MillenniumAvalign Technologies, Inc.KCT2026-10-08
00385640094870INSTRUSAFESummit Medical, Inc.KCT2026-10-08
00385640094832INSTRUSAFESummit Medical, Inc.KCT2026-10-07
00385640094849INSTRUSAFESummit Medical, Inc.KCT2026-10-07
00385640094856INSTRUSAFESummit Medical, Inc.KCT2026-10-07
00385640094863INSTRUSAFESummit Medical, Inc.KCT2026-10-07
00385640094795INSTRUSAFESummit Medical, Inc.KCT2026-10-06
00385640094801INSTRUSAFESummit Medical, Inc.KCT2026-10-06
00385640094818INSTRUSAFESummit Medical, Inc.KCT2026-10-06
00385640094825INSTRUSAFESummit Medical, Inc.KCT2026-10-06
00385640094726INSTRUSAFESummit Medical, Inc.KCT2026-10-05
00385640094733INSTRUSAFESummit Medical, Inc.KCT2026-10-05
00385640094740INSTRUSAFESummit Medical, Inc.KCT2026-10-05
00385640094757INSTRUSAFESummit Medical, Inc.KCT2026-10-05
00385640094764INSTRUSAFESummit Medical, Inc.KCT2026-10-05
00385640094771INSTRUSAFESummit Medical, Inc.KCT2026-10-05
00385640094788INSTRUSAFESummit Medical, Inc.KCT2026-10-05
00724995238360V. MuellerSteris CorporationKCT2026-10-05
00385640094689INSTRUSAFESummit Medical, Inc.KCT2026-10-01
00385640094696INSTRUSAFESummit Medical, Inc.KCT2026-10-01
00385640094702INSTRUSAFESummit Medical, Inc.KCT2026-10-01
00385640094719INSTRUSAFESummit Medical, Inc.KCT2026-10-01
00385640094658INSTRUSAFESummit Medical, Inc.KCT2026-09-30
00385640094665INSTRUSAFESummit Medical, Inc.KCT2026-09-30
00385640094672INSTRUSAFESummit Medical, Inc.KCT2026-09-30