FDA.reportPublic FDA data

Mastel Surgical

Primary DI
00642356006901
Brand
Mastel Surgical
Company
Mastel Surgical Inc.
Model
CP778-DK-2
Catalog number
80.CP778-DK-2
Device description
INSTRUMENT TRAY ASSEMBLY 7.5 X 2.5 X .75 CONSISTS OF LID & SLOTTED BASE W/ 2-5/16" 2 SLOT KNIFE HOLDER, 2 BARS
Published
2026-10-23
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
00642356006901PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00642356006901006423560069016423560069010642356006901

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
00642356006673Mastel SurgicalCP1038D1-SB80.CP1038D1-SB2026-10-23
00642356006680Mastel SurgicalCP1038D1-P-1S/L80.CP1038D1-P-1S/L2026-10-23
00642356006697Mastel SurgicalCP1038D1-P-3S/L80.CP1038D1-P-3S/L2026-10-23
00642356006703Mastel SurgicalCP1038D2-SB80.CP1038D2-SB2026-10-23
00642356006710Mastel SurgicalCP1038S-SB80.CP1038S-SB2026-10-23
00642356006734Mastel SurgicalCP471D1-SB80.CP471D1-SB2026-10-23
00642356006758Mastel SurgicalCP471D1-P-1S/L80.CP471D1-P-1S/L2026-10-23
00642356006765Mastel SurgicalCP471D1-P-3S/L80.CP471D1-P-3S/L2026-10-23
00642356006772Mastel SurgicalCP471S-SB80.CP471S-SB2026-10-23
00642356006789Mastel SurgicalCP471S-DK-280.CP471S-DK-22026-10-23
00642356006796Mastel SurgicalCP471S-DK-380.CP471S-DK-32026-10-23
00642356006802Mastel SurgicalCP471S-DK-480.CP471S-DK-42026-10-23
00642356006819Mastel SurgicalCP471S-DK-580.CP471S-DK-52026-10-23
00642356006826Mastel SurgicalCP614-SB80.CP614-SB2026-10-23
00642356006833Mastel SurgicalCP614-DK-180.CP614-DK-12026-10-23
00642356006840Mastel SurgicalCP614-DK-280.CP614-DK-22026-10-23
00642356006857Mastel SurgicalCP614-DK-380.CP614-DK-32026-10-23
00642356006864Mastel SurgicalCP634-SB80.CP634-SB2026-10-23
00642356006871Mastel SurgicalCP634-DK-580.CP634-DK-52026-10-23
00642356006888Mastel SurgicalCP778-SB80.CP778-SB2026-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00642356006918Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
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