FDA.reportPublic FDA data

KARL STORZ

Primary DI
00817766024993
Brand
KARL STORZ
Company
Tecomet
Model
KSE09022
Catalog number
KSE09022
Device description
"TRAY, BETTOCCHI HYSTEROSCOPY/RESECTION3-LAYER TRAY, DM: 20"" X 9.5"" 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
00817766024993PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817766024993008177660249938177660249930817766024993

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
00817766025006KARL STORZKSE09023KSE090232019-12-12
00817766025020KARL STORZKSE09013-USKSE09013-US2019-12-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00385640095488INSTRUSAFESummit Medical, Inc.KCT2026-11-05
00385640095471INSTRUSAFESummit Medical, Inc.KCT2026-11-04
10886982278746NASynthes GmbHKCT2026-11-03
10886982346421NASynthes GmbHKCT2026-11-03
00385640095433INSTRUSAFESummit Medical, Inc.KCT2026-11-02
00841536147971ThompsonThompson Surgical Instruments, Inc.KCT2026-09-08
00841536147988ThompsonThompson Surgical Instruments, Inc.KCT2026-09-08
00841536148015ThompsonThompson Surgical Instruments, Inc.KCT2026-09-08
00841536148237ThompsonThompson Surgical Instruments, Inc.KCT2026-09-08
00841536148336ThompsonThompson Surgical Instruments, Inc.KCT2026-09-08
00841536148343ThompsonThompson Surgical Instruments, Inc.KCT2026-09-08
00841536148350ThompsonThompson Surgical Instruments, Inc.KCT2026-09-08
00841536148367ThompsonThompson Surgical Instruments, Inc.KCT2026-09-08
00841536147445ThompsonThompson Surgical Instruments, Inc.KCT2026-08-26
00841536147452ThompsonThompson Surgical Instruments, Inc.KCT2026-08-26
00841536147469ThompsonThompson Surgical Instruments, Inc.KCT2026-08-26
00841536147476ThompsonThompson Surgical Instruments, Inc.KCT2026-08-26
00841536147322ThompsonThompson Surgical Instruments, Inc.KCT2026-08-25
00841536147353ThompsonThompson Surgical Instruments, Inc.KCT2026-08-25
00841536147414ThompsonThompson Surgical Instruments, Inc.KCT2026-08-25
00841536148022ThompsonThompson Surgical Instruments, Inc.KCT2026-08-25
00841536148312ThompsonThompson Surgical Instruments, Inc.KCT2026-08-25
00841536148480ThompsonThompson Surgical Instruments, Inc.KCT2026-08-12
00841536148459ThompsonThompson Surgical Instruments, Inc.KCT2026-08-06
00841536148466ThompsonThompson Surgical Instruments, Inc.KCT2026-08-06
00841536147162ThompsonThompson Surgical Instruments, Inc.KCT2025-12-09
00841536146516ThompsonThompson Surgical Instruments, Inc.KCT2025-09-10
00841536146523ThompsonThompson Surgical Instruments, Inc.KCT2025-09-10
00841536146875ThompsonThompson Surgical Instruments, Inc.KCT2025-08-28
00841536146912ThompsonThompson Surgical Instruments, Inc.KCT2025-07-08