FDA.reportPublic FDA data

INSTRUSAFE

Primary DI
00385640039871
Brand
INSTRUSAFE
Company
Summit Medical, Inc.
Model
CS-5500-02
Published
2021-06-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K180528000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180528000InstruSafe(R) Sterilization ContainerSummit Medical, Inc.2018-11-16KCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00385640039871PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00385640039871003856400398713856400398710385640039871

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization/disinfection containerA receptacle designed to hold wrapped and/or unwrapped medical devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots for microsurgical instruments, and stacking capabilities. 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
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
00385640094078INSTRUSAFEIN-8701-R2026-08-21
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817766026355X-Series CaseTecometKCT2026-09-04
00817766026362X-Series CaseTecometKCT2026-09-04
00817766026379X-Series CaseTecometKCT2026-09-04
00817766026386X-Series CaseTecometKCT2026-09-04
00817766026393X-Series CaseTecometKCT2026-09-04
00817766026430X-Series CaseTecometKCT2026-09-04
00817766026447X-Series CaseTecometKCT2026-09-04
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