FDA.reportPublic FDA data

INSTRUSAFE

Primary DI
00385640094078
Brand
INSTRUSAFE
Company
Summit Medical, Inc.
Model
IN-8701-R
Published
2026-08-21
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00385640094078PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00385640094078003856400940783856400940780385640094078

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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00385640094146INSTRUSAFEIN-2020-81562026-08-27
00385640094153INSTRUSAFEIN-2020-81182026-08-27
00385640094160INSTRUSAFEIN-2020-46252026-08-27
00385640094177INSTRUSAFEIN-2020-80712026-08-27
00385640094139INSTRUSAFEIN-2020-80552026-08-26
00385640094108INSTRUSAFEIN-2020-80222026-08-25
00385640094115INSTRUSAFEIN-2020-79442026-08-25
00385640094122INSTRUSAFEIN-2020-81962026-08-25
00385640094030INSTRUSAFEIN-2020-72762026-08-21
00385640094047INSTRUSAFEIN-2020-79432026-08-21
00385640094054INSTRUSAFEIN-2020-81902026-08-21
00385640094061INSTRUSAFEIN-8701-NF2026-08-21
00385640094085INSTRUSAFEIN-8701-TF2026-08-21
00385640094016INSTRUSAFEIN-2020-80652026-08-19
00385640094023INSTRUSAFEIN-2020-80482026-08-19
00385640093972INSTRUSAFEIN-2020-78952026-08-18
00385640093989INSTRUSAFEIN-2020-81052026-08-18
00385640094009INSTRUSAFEIN-2020-80542026-08-18
00385640093941INSTRUSAFEIN-2020-78962026-08-14
00385640093958INSTRUSAFEIN-2020-81732026-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00385640094146INSTRUSAFESummit Medical, Inc.KCT2026-08-27
00385640094153INSTRUSAFESummit Medical, Inc.KCT2026-08-27
00385640094160INSTRUSAFESummit Medical, Inc.KCT2026-08-27
00385640094177INSTRUSAFESummit Medical, Inc.KCT2026-08-27
00385640094139INSTRUSAFESummit Medical, Inc.KCT2026-08-26
00724995234232V. MuellerSteris CorporationKCT2026-08-26
00724995234249V. MuellerSteris CorporationKCT2026-08-26
00724995234256V. MuellerSteris CorporationKCT2026-08-26
00724995234263V. MuellerSteris CorporationKCT2026-08-26
00724995234270V. MuellerSteris CorporationKCT2026-08-26
00724995234287V. MuellerSteris CorporationKCT2026-08-26
00724995234294V. MuellerSteris CorporationKCT2026-08-26
00724995234300V. MuellerSteris CorporationKCT2026-08-26
00724995234317V. MuellerSteris CorporationKCT2026-08-26
00724995234324V. MuellerSteris CorporationKCT2026-08-26
00724995234331V. MuellerSteris CorporationKCT2026-08-26
00724995234348V. MuellerSteris CorporationKCT2026-08-26
00724995234355V. MuellerSteris CorporationKCT2026-08-26
00724995234362V. MuellerSteris CorporationKCT2026-08-26
00724995234379V. MuellerSteris CorporationKCT2026-08-26
00724995234386V. MuellerSteris CorporationKCT2026-08-26
00724995234393V. MuellerSteris CorporationKCT2026-08-26
00724995234409V. MuellerSteris CorporationKCT2026-08-26
00724995234416V. MuellerSteris CorporationKCT2026-08-26
00724995234423V. MuellerSteris CorporationKCT2026-08-26
00724995234430V. MuellerSteris CorporationKCT2026-08-26
00724995234447V. MuellerSteris CorporationKCT2026-08-26
00724995234454V. MuellerSteris CorporationKCT2026-08-26
00724995234461V. MuellerSteris CorporationKCT2026-08-26
00724995234478V. MuellerSteris CorporationKCT2026-08-26