FDA.reportPublic FDA data

SteriBest

Primary DI
00642356006468
Brand
SteriBest
Company
Mastel Surgical Inc.
Model
CP471S-NM-SB
Catalog number
CP471S-NM-SB
Device description
INSTRUMENT TRAY ASSEMBLY 7.5 X 4 X .75 CONSISTS OF LID, SLOTTED SHALLOW BASE
Published
2026-10-22
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
K253187000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253187000SteriBest® Sterilization Tray SystemMastel Surgical2026-06-18KCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00642356006468PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00642356006468006423560064686423560064680642356006468

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
789897865
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
00642356006215Storz Ophthalmic InstrumentsCP634-SBE74092026-10-22
00642356006222Storz Ophthalmic InstrumentsCP1038S-SBE74062026-10-22
00642356006239Storz Ophthalmic InstrumentsCP614-DK-2E74072026-10-22
00642356006246Storz Ophthalmic InstrumentsCP1038D2-SBE74112026-10-22
00642356006253SteriBestCP1038D1-P-1S/LCP1038D1-P-1S/L2026-10-22
00642356006260SteriBestCP1038D1-P-3S/LCP1038D1-P-3S/L2026-10-22
00642356006277SteriBestCP1038D1-SBCP1038D1-SB2026-10-22
00642356006284SteriBestCP1038D2-SBCP1038D2-SB2026-10-22
00642356006291SteriBestCP1038D1-NM-SBCP1038D1-NM-SB2026-10-22
00642356006345SteriBestCP1038D2-NM-SBCP1038D2-NM-SB2026-10-22
00642356006352SteriBestCP1038S-SBCP1038S-SB2026-10-22
00642356006369SteriBestCP1038S-NM-SBCP1038S-NM-SB2026-10-22
00642356006376SteriBestCP471D1-P-1S/LCP471D1-P-1S/L2026-10-22
00642356006383SteriBestCP471D1-P-3S/LCP471D1-P-3S/L2026-10-22
00642356006390SteriBestCP471D1-SBCP471D1-SB2026-10-22
00642356006406SteriBestCP471D1-NM-SBCP471D1-NM-SB2026-10-22
00642356006413SteriBestCP471S-DK-2CP471S-DK-22026-10-22
00642356006420SteriBestCP471S-DK-3CP471S-DK-32026-10-22
00642356006437SteriBestCP471S-DK-4CP471S-DK-42026-10-22
00642356006444SteriBestCP471S-DK-5CP471S-DK-52026-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00385640095297INSTRUSAFESummit Medical, Inc.KCT2026-10-22
00642356006215Storz Ophthalmic InstrumentsMastel Surgical Inc.KCT2026-10-22
00642356006222Storz Ophthalmic InstrumentsMastel Surgical Inc.KCT2026-10-22
00642356006239Storz Ophthalmic InstrumentsMastel Surgical Inc.KCT2026-10-22
00642356006246Storz Ophthalmic InstrumentsMastel Surgical Inc.KCT2026-10-22
00642356006253SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006260SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006277SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006284SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006291SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006345SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006352SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006369SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006376SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006383SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006390SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006406SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006413SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006420SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006437SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006444SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006451SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006475SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006482SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006499SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006505SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006512SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006529SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006536SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006543SteriBestMastel Surgical Inc.KCT2026-10-22