FDA.reportPublic FDA data

Mastel Surgical

Primary DI
00642356004396
Brand
Mastel Surgical
Company
Mastel Surgical Inc.
Model
CP1038D1-SB
Catalog number
AT0195
Device description
"MICRO INSTRUMENT TRAY 10"" X 6"" X 1.5"""
Published
2025-12-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LRPTray, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRPTray, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00642356004396PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00642356004396006423560043966423560043960642356004396

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
789897865
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00642356005041Mastel SurgicalKWR-4002026-04-13
00642356005058Mastel SurgicalKWR-6002026-04-13
00642356005065Mastel SurgicalKWR-9002026-04-13
00642356004709Mastel Surgical Inc.20.110.070220.110.07022026-02-11
00642356004389SteriBest44-0207412025-12-09
00642356004204SteriBestCP614-SBAT02102025-11-20
00642356002972SteriBestCP1038D1-SB80.CP1038D12025-11-06
00642356002989SteriBestCP1038D1-P-1S/L80.CP1038D1-P-1S/L2025-11-06
00642356002996SteriBestCP1038D1-P-3S/L80.CP1038D1-P-3S/L2025-11-06
00642356003009SteriBestCP1038D2-SB80.CP1038D22025-11-06
00642356003016SteriBestCP1038S-SB80.CP1038S2025-11-06
00642356003023SteriBestCP471D1-SB80.CP471D12025-11-06
00642356003030SteriBestCP471D1-P-1S/L80.CP471D1-P-1S/L2025-11-06
00642356003047SteriBestCP471D1-P-3S/L80.CP471D1-P-3S/L2025-11-06
00642356003054SteriBestCP471S-SB80.CP471S2025-11-06
00642356003061SteriBestCP471S-DK-280.CP471S-DK-22025-11-06
00642356003078SteriBestCP471S-DK-380.CP471S-DK-32025-11-06
00642356003085SteriBestCP471S-DK-480.CP471S-DK-42025-11-06
00642356003092SteriBestCP471S-DK-580.CP471S-DK-52025-11-06
00642356003108SteriBestCP614-SB80.CP6142025-11-06

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Primary DI, Brand, Company table
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10198956501607CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-03
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10198956500389CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-01
07649988948725SPIRECUTSPIRECUT SALRP2026-05-04
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