FDA.reportPublic FDA data

KARL STORZ

Primary DI
00817766025129
Brand
KARL STORZ
Company
Tecomet
Model
KSE09034
Catalog number
KSE09034
Device description
"TRAY, SAWALHE MORCELLATORDM: 20"" X 9.8"" X 5"""
Published
2019-12-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K012105000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012105000POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEMSymmetry Medical, Inc.2002-08-02KCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817766025129PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817766025129008177660251298177660251290817766025129

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
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
118087931
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817766026355X-Series Case87-197489-8523-100-402026-09-04
00817766026362X-Series Case87-197589-8523-100-502026-09-04
00817766026379X-Series Case87-197989-8523-100-302026-09-04
00817766026386X-Series Case87-198089-8523-100-202026-09-04
00817766026393X-Series Case87-198189-8523-300-102026-09-04
00817766026430X-Series Case87-204289-8523-100-702026-09-04
00817766026447X-Series Case87-204189-8523-100-602026-09-04
00817766026461Case 2 Complete2500-00-7942023-09-22
00817766026249Smith & Nephew Tray - Offset Cup Impactor Lid33000206-35122020-05-14
00817766026348Smith & Nephew Tray - Offset Cup Impactor Base33000306-35132020-05-14
00817766024863KARL STORZ04-1268-US04-1268-US2019-12-12
00817766024870KARL STORZ05-327505-32752019-12-12
00817766024887KARL STORZKSE09007KSE090072019-12-12
00817766024900KARL STORZKSE09006KSE090062019-12-12
00817766024931KARL STORZKSE09024KSE090242019-12-12
00817766024948KARL STORZKSE09044KSE090442019-12-12
00817766024979KARL STORZKSE09015KSE090152019-12-12
00817766024986KARL STORZKSE09016KSE090162019-12-12
00817766024993KARL STORZKSE09022KSE090222019-12-12
00817766025006KARL STORZKSE09023KSE090232019-12-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00385640095082INSTRUSAFESummit Medical, Inc.KCT2026-10-15
00385640095099INSTRUSAFESummit Medical, Inc.KCT2026-10-15
00385640095105INSTRUSAFESummit Medical, Inc.KCT2026-10-15
00385640095112INSTRUSAFESummit Medical, Inc.KCT2026-10-15
00385640095129INSTRUSAFESummit Medical, Inc.KCT2026-10-15
00385640095136INSTRUSAFESummit Medical, Inc.KCT2026-10-15
00385640095143INSTRUSAFESummit Medical, Inc.KCT2026-10-15
00385640095150INSTRUSAFESummit Medical, Inc.KCT2026-10-15
00724995239909V. MuellerSteris CorporationKCT2026-10-15
00724995239916V. MuellerSteris CorporationKCT2026-10-15
00724995239923V. MuellerSteris CorporationKCT2026-10-15
00724995239930V. MuellerSteris CorporationKCT2026-10-15
00724995239947V. MuellerSteris CorporationKCT2026-10-15
00724995240660V. MuellerSteris CorporationKCT2026-10-15
00724995240677V. MuellerSteris CorporationKCT2026-10-15
00724995240684V. MuellerSteris CorporationKCT2026-10-15
00724995240691V. MuellerSteris CorporationKCT2026-10-15
00724995240707V. MuellerSteris CorporationKCT2026-10-15
00724995241025V. MuellerSteris CorporationKCT2026-10-15
00724995241049V. MuellerSteris CorporationKCT2026-10-15
00724995241056V. MuellerSteris CorporationKCT2026-10-15
00724995241063V. MuellerSteris CorporationKCT2026-10-15
00724995241070V. MuellerSteris CorporationKCT2026-10-15
00724995241087V. MuellerSteris CorporationKCT2026-10-15
00724995241094V. MuellerSteris CorporationKCT2026-10-15
00724995241100V. MuellerSteris CorporationKCT2026-10-15
00724995241117V. MuellerSteris CorporationKCT2026-10-15
00724995241131V. MuellerSteris CorporationKCT2026-10-15
00724995241148V. MuellerSteris CorporationKCT2026-10-15
00724995241155V. MuellerSteris CorporationKCT2026-10-15