FDA.reportPublic FDA data

SteriBest

Primary DI
00642356004204
Brand
SteriBest
Company
Mastel Surgical Inc.
Model
CP614-SB
Catalog number
AT0210
Device description
INSTRUMENT TRAY 6 X 2.5 X .75 INCL. LID, BASE, MAT
Published
2025-11-20
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
00642356004204PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00642356004204006423560042046423560042040642356004204

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
00642356004396Mastel SurgicalCP1038D1-SBAT01952025-12-09
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04052536162116neon3Ulrich GmbH & Co. KGLRP2026-06-08
04052536162130neon3Ulrich GmbH & Co. KGLRP2026-06-08
04052536162147neon3Ulrich GmbH & Co. KGLRP2026-06-08
04052536162154neon3Ulrich GmbH & Co. KGLRP2026-06-08
04052536162215neon3Ulrich GmbH & Co. KGLRP2026-06-08
04052536176724neon3Ulrich GmbH & Co. KGLRP2026-06-08
04052536176748neon3Ulrich GmbH & Co. KGLRP2026-06-08
04052536176755neon3Ulrich GmbH & Co. KGLRP2026-06-08
04052536176762neon3Ulrich GmbH & Co. KGLRP2026-06-08
10198956433755CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956461109CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956476950CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956479999CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956485112CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956487475CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956490109CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956490635CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956494817CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956501362CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956505841CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956506381CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956506398CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956506763CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956507968CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956508842CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956367647CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-05
10198956484122CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-05
10198956484351CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-05
10198956503076CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-05
10198956507050CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-05