FDA.reportPublic FDA data

INSTRUSAFE

Primary DI
00385640088015
Brand
INSTRUSAFE
Company
Summit Medical, Inc.
Model
OM-1001-LV
Published
2025-08-13
Public version status
New
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00385640088015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00385640088015003856400880153856400880150385640088015

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.

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
00385640072403Quintess®16572026-05-13
00385640072410Quintess®16582026-05-13
00385640091794INSTRUSAFEIN-2020-77532026-05-13
00385640091800INSTRUSAFEIN-2020-78032026-05-13
00385640091817INSTRUSAFEIN-2020-77512026-05-13
00385640091824INSTRUSAFEIN-2020-77932026-05-13
00385640091831INSTRUSAFEIN-2020-77042026-05-13
00385640091848INSTRUSAFEIN-2020-72672026-05-13
00385640091855INSTRUSAFEIN-2550-05-EN-0622026-05-13
00385640091862INSTRUSAFEIN-2550-05-EN-0632026-05-13
00385640091879INSTRUSAFEIN-2550-05-EN-0642026-05-13
00385640091886INSTRUSAFEIN-2550-05-EN-0652026-05-13
00385640091893INSTRUSAFEIN-2600-04-EN-0852026-05-13
00385640091909INSTRUSAFEIN-2020-76362026-05-13
00385640091916INSTRUSAFEIN-2020-76942026-05-13
00385640091923INSTRUSAFEIN-2020-77962026-05-13
00385640091930INSTRUSAFEIN-2020-78852026-05-13
00385640091947INSTRUSAFEIN-2020-78272026-05-13
00385640091954INSTRUSAFEIN-2020-78302026-05-13
00385640091961INSTRUSAFEIN-2020-78292026-05-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810166522809X-PACEXPANDING INNOVATIONS, INC.KCT2026-05-27
07640166769521Z5m(t)-neo InsertZ-Systems AGKCT2026-05-17
07640166769651Z5m(t)-neo Tray FullZ-Systems AGKCT2026-05-17
07640462720332NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
07640462720660NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
07640462720677NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
07640462720684NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
07630031782298Straumann Modular CassetteInstitut Straumann AGKCT2026-05-07
10197344177806MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344177813MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344177820MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178117MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178124MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178285MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178353MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178438MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178469MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178476MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178490MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178506MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178513MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178568MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178629MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178650MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178667MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178698MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344177783MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-15
10197344177790MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-15
10197344177950MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-15
10197344177967MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-15