FDA.reportPublic FDA data

Sterilization Cassette

Primary DI
06973993446022
Brand
Sterilization Cassette
Company
Alliedstar Medical Equipment Co., Ltd.
Model
CASS-1
Published
2026-10-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
K262042000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K262042000Sterilization Cassette (CASS-1)Alliedstar Medical Equipment Co., Ltd.2026-10-14KCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06973993446022PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973993446022069739934460226973993446022

GMDN Terms#

Term, Definition table
TermDefinition
Device 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.

Regulatory Flags#

DUNS number
703541803
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
06973993440440SprintRay Foundation HandpieceS300W65836592026-10-23
06973993442758SprintRay Foundation ScannerS300W65836432026-10-23
06973993443212SprintRay Foundation Charging DockCHR 300W65836582026-10-23
06973993443229SprintRay Foundation Scanner Tip (2pcs)TP30165836602026-10-23
06973993442499Intraoral ScannerST 200EST6583202H2026-04-20
06973993444059AlliedstarDIP-A65835712026-02-17
16973993444056AlliedstarDIP-A65835712026-02-17
06973993440785AlliedstarAS 200E65832172025-12-11
06973993440808AlliedstarAS 26065832432025-12-11
06973993441119AlliedstarLi-18650-3.6V 3400mAh-PCM-Cap65832212025-12-11
06973993441522Alliedstar/65832442025-12-11
06973993441539Alliedstar/65832452025-12-11
06973993441546Alliedstar/65832462025-12-11
06973993441775AlliedstarCHR 200E65832032025-12-11
06973993442307AlliedstarAS 200E65833802025-12-11
06973993442314AlliedstarAS 200E65833862025-12-11
06973993442765AlliedstarAS 200E65832022025-12-11
06973993442796AlliedstarAS 26065832072025-12-11
06973993442819AlliedstarAS 26065832862025-12-11
06973993442826AlliedstarAS 26065833822025-12-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00385640095327INSTRUSAFESummit Medical, Inc.KCT2026-10-26
00385640095334INSTRUSAFESummit Medical, Inc.KCT2026-10-26
03701045278962KONTACTBIOTECH DENTALKCT2026-10-26
03701045278979KONTACTBIOTECH DENTALKCT2026-10-26
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
00642356006697Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006703Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006710Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006734Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006758Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006765Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006772Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006789Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006796Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006802Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006819Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006826Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006833Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006840Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006857Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006864Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006871Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006888Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006895Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006901Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006918Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00385640095297INSTRUSAFESummit Medical, Inc.KCT2026-10-22