FDA.reportPublic FDA data

INSTRUSAFE

Primary DI
00385640095433
Brand
INSTRUSAFE
Company
Summit Medical, Inc.
Model
IN-2020-8303
Published
2026-11-02
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051157000
K133015000
K140289000
K141513000
K142630000
K142768000
K150540000
K151166000
K210836000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051157000INSTRU-SAFE INSTRUMENT PROTECTION SYSTEMSMicromedics, Inc.2005-09-01KCT
K133015000INSTRU-SAFE INSTRUMENT PROTECTION SYSTEMSummit Medical, Inc.2014-03-13KCT
K140289000INSTRU-SAFE INSTRUMENT PROTECTION SYSTEMSummit Medical, Inc.2014-06-27KCT
K141513000INSTRU-SAFE INSTRUMENT PROTECTION SYSTEMSummit Medical, Inc.2014-12-15KCT
K142630000Instru-Safe Instrument Protection SystemSummit Medical, Inc.2014-12-23KCT
K142768000Instru-Safe Instrument Protection SystemSummit Medical, Inc.2015-05-29KCT
K150540000Instru-Safe Instrument Protection SystemSummit Medical, Inc.2015-06-22KCT
K151166000Instru-Safe Instrument Protection SystemSummit Medical, Inc.2015-08-18KCT
K210836000InstruSafe Instrument Protection SystemSummitt Medical, LLC2021-11-30KCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00385640095433PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00385640095433003856400954333856400954330385640095433

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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00385640095440INSTRUSAFEIN-2020-82982026-11-02
00385640095457INSTRUSAFEIN-2020-82992026-11-02
00385640095464INSTRUSAFEIN-2020-83592026-11-02
00385640095419INSTRUSAFEIN-2020-83112026-10-30
00385640095426INSTRUSAFEIN-2020-83022026-10-30
00385640095372INSTRUSAFEIN-2020-81762026-10-29
00385640095389INSTRUSAFEIN-2020-83152026-10-29
00385640095396INSTRUSAFEIN-2020-82502026-10-29
00385640095402INSTRUSAFEIN-2020-83122026-10-29
00385640095341INSTRUSAFEIN-2020-82482026-10-28
00385640095358INSTRUSAFEIN-2020-83552026-10-28
00385640095365INSTRUSAFEIN-2020-81752026-10-28
00385640095327INSTRUSAFEIN-2020-83042026-10-26
00385640095334INSTRUSAFEIN-2020-82422026-10-26
00385640095303INSTRUSAFEIN-2020-83002026-10-23
00385640095310INSTRUSAFEIN-2020-78492026-10-23
00385640095297INSTRUSAFEIN-2020-82162026-10-22
00385640095211INSTRUSAFEIN-3030-03262026-10-21
00385640095228INSTRUSAFEIN-2020-82942026-10-21
00385640095235INSTRUSAFEIN-2300-05-EN-1542026-10-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00385640095440INSTRUSAFESummit Medical, Inc.KCT2026-11-02
00385640095457INSTRUSAFESummit Medical, Inc.KCT2026-11-02
00385640095464INSTRUSAFESummit Medical, Inc.KCT2026-11-02
00385640095419INSTRUSAFESummit Medical, Inc.KCT2026-10-30
00385640095426INSTRUSAFESummit Medical, Inc.KCT2026-10-30
00385640095372INSTRUSAFESummit Medical, Inc.KCT2026-10-29
00385640095389INSTRUSAFESummit Medical, Inc.KCT2026-10-29
00385640095396INSTRUSAFESummit Medical, Inc.KCT2026-10-29
00385640095402INSTRUSAFESummit Medical, Inc.KCT2026-10-29
07899995223999ORGANIZER BOX VERSALISSin Sistema de Implante Nacional S/AKCT2026-10-29
07899995234322Organizar Box Beyond Full Arch SurgicalSin Sistema de Implante Nacional S/AKCT2026-10-29
07899995234339Organizer Box Intraoral Pro Scanning StarterSin Sistema de Implante Nacional S/AKCT2026-10-29
07899995237705Organizer Box Intraoral Pro Scanning PremiumSin Sistema de Implante Nacional S/AKCT2026-10-29
07899995237712Beyond Full Arch Surgical KitSin Sistema de Implante Nacional S/AKCT2026-10-29
07899995237729Intraoral Pro Scanning Premium KitSin Sistema de Implante Nacional S/AKCT2026-10-29
07899995237736Intraoral Pro Scanning Starter KitSin Sistema de Implante Nacional S/AKCT2026-10-29
00385640095341INSTRUSAFESummit Medical, Inc.KCT2026-10-28
00385640095358INSTRUSAFESummit Medical, Inc.KCT2026-10-28
00385640095365INSTRUSAFESummit Medical, Inc.KCT2026-10-28
07899995224002SURGICAL KIT VERSALISSin Sistema de Implante Nacional S/AKCT2026-10-28
G476ISTO20X10X2ISTO BIOLOGICS SteriZign Sterilization TraySterizign Precision Technologies, LLCKCT2026-10-27
00385640095327INSTRUSAFESummit Medical, Inc.KCT2026-10-26
00385640095334INSTRUSAFESummit Medical, Inc.KCT2026-10-26
03701045278962KONTACTBIOTECH DENTALKCT2026-10-26
03701045278979KONTACTBIOTECH DENTALKCT2026-10-26
06973993446022Sterilization CassetteAlliedstar Medical Equipment Co., Ltd.KCT2026-10-26
00385640095303INSTRUSAFESummit Medical, Inc.KCT2026-10-23
00385640095310INSTRUSAFESummit Medical, Inc.KCT2026-10-23
00642356006673Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006680Mastel SurgicalMastel Surgical Inc.KCT2026-10-23