FDA.reportPublic FDA data

Sterilization Tray

Primary DI
M896IBIT00010
Brand
Sterilization Tray
Company
Arteriocyte Medical Systems, Inc.
Model
IB-IT-0001
Catalog number
IB-IT-0001
Device description
Reusable sterilization tray used to hold and organize surgical instruments during cleaning, sterilization, transport, and storage.
Published
2022-11-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K171520000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171520000SteriZign Signatur Device Protection SystemSterizign Precision Technologies, LLC2018-02-07KCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M896IBIT00010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization/disinfection container, reusableA receptacle designed to hold wrapped and/or unwrapped medical/dental 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 or inserts to hold instruments, and stacking capabilities. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
888-705-4786customerservice@istobiologics.com

Regulatory Flags#

DUNS number
809012870
Device count
1
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M896AMS1000Magellan Autologous Platelet Separator SystemAMS100AMS1002016-09-09
M896AMS3000Magellan Complete Disposable KitAMS300AMS3002016-09-12
M896AMS3050Magellan Basic disposable kitAMS305AMS3052016-09-12
M896AMS3100Magellan Complete One Source KitAMS310AMS3102016-09-12
M896BTI2000Magellan Autologous Platelet Separator SystemBTI200BTI2002016-09-09
M896CLPTPK1010CP Disposable KitCLPT-PK-101CLPT-PK-1012018-12-12
M896CLPTPK101450Cellpoint CP Disposable Kit with 45mm Lightning NeedleCLPT-PK-101-45CLPT-PK-101-452020-02-26
M896IBIA55600Small Anchor Awl 5mmIB-IA-5560IB-IA-55602022-12-19
M896IBIA65700Medium Anchor Awl 6mmIB-IA-6570IB-IA-65702022-12-19
M896IBIA75800Large Anchor Awl 7mmIB-IA-7580IB-IA-75802022-12-19
M896IBIA85900Xlarge Anchor Awl 8mmIB-IA-8590IB-IA-85902022-12-19
M896IBK00010Fibrant Instrument Kit IB-K-0001IB-K-00012022-12-19
M896IQSPMX1500InQu Matrix 5x10cmIQSP-MX-150IQSP-MX-1502022-06-23
M896IQSPPP1010InQu Paste Mix Plus 1.25ccIQSP-PP-101IQSP-PP-1012018-08-01
M896IQSPPP1020InQu Paste Mix Plus 2.5ccIQSP-PP-102IQSP-PP-1022018-08-01
M896IQSPPP1050InQu Paste Mix Plus 5ccIQSP-PP-105IQSP-PP-1052018-08-01
M896IQSPPP1100InQu Paste Mix Plus 10ccIQSP-PP-110IQSP-PP-1102018-08-01
M896MAG1000Magellan Autologous Platelet Separator SystemMAG100MAG1002016-09-09
M896MAG2000Magellan Autologous Platelet Separator SystemMAG200MAG2002016-09-09
M896MAR0MAX450Magellan MAR0Max QuickDraw Convenience KitMAR0Max45MAR0Max452016-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810166522809X-PACEXPANDING INNOVATIONS, INC.KCT2026-05-27
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07640462720660NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
07640462720677NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
07640462720684NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
07630031782298Straumann Modular CassetteInstitut Straumann AGKCT2026-05-07
10197344177806MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
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