FDA.reportPublic FDA data

INSTRUSAFE

Primary DI
00385640095204
Brand
INSTRUSAFE
Company
Summit Medical, Inc.
Model
IN-2020-8273
Published
2026-10-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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
00385640095204PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00385640095204003856400952043856400952040385640095204

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental 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 is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

Regulatory Flags#

DUNS number
965484699
Device count
1
DM exempt
false
Premarket exempt
false
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00385640095174INSTRUSAFEIN-2020-80252026-10-20
00385640095181INSTRUSAFEIN-2020-82952026-10-20
00385640095198INSTRUSAFEIN-2020-82282026-10-20
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776437695MilleniumAvalign Technologies, Inc.KCT2026-10-20
00385640095174INSTRUSAFESummit Medical, Inc.KCT2026-10-20
00385640095181INSTRUSAFESummit Medical, Inc.KCT2026-10-20
00385640095198INSTRUSAFESummit Medical, Inc.KCT2026-10-20
G476STER16X5X1625SteriZIgn Sterilization TraySterizign Precision Technologies, LLCKCT2026-10-20
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