FDA.report

INSTRUSAFE

Primary DI
00385640029629
Brand
INSTRUSAFE
Company
SUMMIT MEDICAL, INC.
Model
IN-2020-1617
Published
2017-08-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories

Product Code Classifications

CodeDeviceSpecialtyClass
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00385640029629PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00385640029629003856400296293856400296290385640029629

GMDN Terms

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

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
true
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
00385640091183INSTRUSAFESummit Medical, Inc.KCT2026-03-24
00385640091190INSTRUSAFESummit Medical, Inc.KCT2026-03-24
00385640091206INSTRUSAFESummit Medical, Inc.KCT2026-03-24
00385640091152INSTRUSAFESummit Medical, Inc.KCT2026-03-23
00385640091169INSTRUSAFESummit Medical, Inc.KCT2026-03-23
00385640091176INSTRUSAFESummit Medical, Inc.KCT2026-03-23
00199150051212Medtronic Reusable Instruments and AccessoriesMEDTRONIC SOFAMOR DANEK, INC.KCT2026-03-22
00763000710194Medtronic Reusable Instruments and AccessoriesMEDTRONIC SOFAMOR DANEK, INC.KCT2026-03-22
00199150015429CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KCT2026-03-21
00199150015436CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KCT2026-03-21
00763000869069CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KCT2026-03-21
00763000869076CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KCT2026-03-21
00763000869090CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KCT2026-03-21
00763000869106CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KCT2026-03-21
00763000869892CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KCT2026-03-21
00763000869908CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KCT2026-03-21
00763000869915CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KCT2026-03-21
00763000869922CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KCT2026-03-21
00763000869939CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KCT2026-03-21
00385640091114INSTRUSAFESummit Medical, Inc.KCT2026-03-20
00385640091121INSTRUSAFESummit Medical, Inc.KCT2026-03-20
00385640091138INSTRUSAFESummit Medical, Inc.KCT2026-03-20
00385640091145INSTRUSAFESummit Medical, Inc.KCT2026-03-20
00653159013232CASE MEDICALCase Medical Inc.KCT2026-03-20
00653159013256CASE MEDICALCase Medical Inc.KCT2026-03-20
00653159014062CASE MEDICALCase Medical Inc.KCT2026-03-20
00653159014086CASE MEDICALCase Medical Inc.KCT2026-03-20
00653159014123CASE MEDICALCase Medical Inc.KCT2026-03-20
00653159014727CASE MEDICALCase Medical Inc.KCT2026-03-20
00653159014734CASE MEDICALCase Medical Inc.KCT2026-03-20