FDA.reportPublic FDA data

Instrusafe

Primary DI
00385640034333
Brand
Instrusafe
Company
SUMMIT MEDICAL, INC.
Model
IN-2020-0438
Published
2018-01-27
Public version status
Update
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00385640034333PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00385640034333003856400343333856400343330385640034333

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
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 DI, Brand, Model table
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850016403049ActivSight Imaging Module Clean and Disinfect TrayActiv Surgical, Inc.KCT2026-05-26
00850016403063ActivSight Light Cable Sterilization TrayActiv Surgical, Inc.KCT2026-05-26
00850016403070ActivSight Imaging Module Tray for VHPActiv Surgical, Inc.KCT2026-05-26
00850016403193ActivSight Laparoscope Sterilization TrayActiv Surgical, Inc.KCT2026-05-26
00857387006534Stryker Universal Select Sterilization Tray SystemPARAGON MEDICAL, INC.KCT2026-05-26
00857387006541Stryker Universal Select Sterilization Tray SystemPARAGON MEDICAL, INC.KCT2026-05-26
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