FDA.reportPublic FDA data

Z5m(t)-neo Insert

Primary DI
07640166769521
Brand
Z5m(t)-neo Insert
Company
Z-Systems AG
Model
Z5m(t)-neo Insert
Catalog number
Z5m(t)-neo Insert
Device description
Surgical Insert Z5m(t)-neo
Published
2026-05-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
K201878000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201878000ST-Z5Z-Systems AG2021-03-25KCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640166769521PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640166769521076401667695217640166769521

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
(877) 874 9407contact@zsystems.com
+41623886969support@zsystems.com

Regulatory Flags#

DUNS number
483189556
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
07640166763567Z5m(t)-neoZ5m(t)-neo-4008Z5m(t)-neo-40082026-05-17
07640166763574Z5m(t)-neoZ5m(t)-neo-4010Z5m(t)-neo-40102026-05-17
07640166763581Z5m(t)-neoZ5m(t)-neo-4012Z5m(t)-neo-40122026-05-17
07640166763703Z5m(t)-neoZ5m(t)-neo-5008Z5m(t)-neo-50082026-05-17
07640166763710Z5m(t)-neoZ5m(t)-neo-5010Z5m(t)-neo-50102026-05-17
07640166763727Z5m(t)-neoZ5m(t)-neo-5012Z5m(t)-neo-50122026-05-17
07640166763741FD400-neoFD400-neoFD400-neo2026-05-17
07640166763758FD500-neoFD500-neoFD500-neo2026-05-17
07640166765905TD230-1TD230-1TD230-12026-05-17
07640166765936TD285-1TD285-1TD285-12026-05-17
07640166769651Z5m(t)-neo Tray FullZ5m(t)-neo Tray FullZ5m(t)-neo Tray Full2026-05-17
07640166769668DP230-1DP230-1DP230-12026-05-17
07640166769675DP285-1DP285-1DP285-12026-05-17
07640166760405Z5cZ5c-40-08Z5c-40-082015-08-25
07640166760412Z5cZ5c-40-10Z5c-40-102015-08-25
07640166760429Z5cZ5c-40-12Z5c-40-122015-08-25
07640166760436Z5cZ5c-50-08Z5c-50-082015-08-25
07640166760443Z5cZ5c-50-10Z5c-50-102015-08-25
07640166760450Z5cZ5c-50-12Z5c-50-122015-08-25
07640166769491Z5mZ5m-36-10Z5m-36-102015-08-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G476TENZ20X10X2Tenzin SteriZIgn Sterilization TraySterizign Precision Technologies, LLCKCT2026-09-25
00385640094535INSTRUSAFESummit Medical, Inc.KCT2026-09-24
00385640094542INSTRUSAFESummit Medical, Inc.KCT2026-09-24
00385640094559INSTRUSAFESummit Medical, Inc.KCT2026-09-24
00724995237059V. MuellerSteris CorporationKCT2026-09-24
00724995237066V. MuellerSteris CorporationKCT2026-09-24
00724995237073V. MuellerSteris CorporationKCT2026-09-24
00724995237080V. MuellerSteris CorporationKCT2026-09-24
00724995237097V. MuellerSteris CorporationKCT2026-09-24
00724995237103V. MuellerSteris CorporationKCT2026-09-24
00724995237110V. MuellerSteris CorporationKCT2026-09-24
00724995237127V. MuellerSteris CorporationKCT2026-09-24
00724995237134V. MuellerSteris CorporationKCT2026-09-24
00724995237141V. MuellerSteris CorporationKCT2026-09-24
00724995237158V. MuellerSteris CorporationKCT2026-09-24
00724995237165V. MuellerSteris CorporationKCT2026-09-24
00724995237172V. MuellerSteris CorporationKCT2026-09-24
00724995237189V. MuellerSteris CorporationKCT2026-09-24
00724995237196V. MuellerSteris CorporationKCT2026-09-24
00724995237202V. MuellerSteris CorporationKCT2026-09-24
00724995237219V. MuellerSteris CorporationKCT2026-09-24
00724995237226V. MuellerSteris CorporationKCT2026-09-24
00724995237233V. MuellerSteris CorporationKCT2026-09-24
00724995237240V. MuellerSteris CorporationKCT2026-09-24
00724995237257V. MuellerSteris CorporationKCT2026-09-24
00724995237264V. MuellerSteris CorporationKCT2026-09-24
00724995237271V. MuellerSteris CorporationKCT2026-09-24
00724995237288V. MuellerSteris CorporationKCT2026-09-24
00724995237295V. MuellerSteris CorporationKCT2026-09-24
00724995237301V. MuellerSteris CorporationKCT2026-09-24