FDA.reportPublic FDA data

SteriBest

Primary DI
00642356002989
Brand
SteriBest
Company
Mastel Surgical Inc.
Model
CP1038D1-P-1S/L
Catalog number
80.CP1038D1-P-1S/L
Device description
"INSTRUMENT TRAY 10 X 6 X 1.5 INCL. LID & SLOTTED DEEP BASE W/ 3-3/16"" 1 SLOT PHACO HOLDER"
Published
2025-11-06
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
00642356002989PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00642356002989006423560029896423560029890642356002989

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
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00642356005812SteriBestCP471D1-SBAT01552026-07-28
00642356005645SteriBest44-0218122026-07-22
00642356002972SteriBestCP1038D1-SB80.CP1038D1-SB2025-11-06
00642356003009SteriBestCP1038D2-SB80.CP1038D2-SB2025-11-06
00642356003016SteriBestCP1038S-SB80.CP1038S-SB2025-11-06
00642356003023SteriBestCP471D1-SB80.CP471D1-SB2025-11-06
00642356003054SteriBestCP471S-SB80.CP471S-SB2025-11-06
00642356003108SteriBestCP614-SB80.CP614-SB2025-11-06
00642356003146SteriBestCP634-SB80.CP634-SB2025-11-06
00642356003160SteriBestCP778-SB80.CP778-SB2025-11-06
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
00642356004204SteriBestCP614-SBAT02102025-11-20
00642356002996SteriBestCP1038D1-P-3S/L80.CP1038D1-P-3S/L2025-11-06
00642356003030SteriBestCP471D1-P-1S/L80.CP471D1-P-1S/L2025-11-06
00642356003047SteriBestCP471D1-P-3S/L80.CP471D1-P-3S/L2025-11-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956210240CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956310933CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956480322CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956538337CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956546431CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956564503CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956572713CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956573963CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956575622CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956576575CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956577404CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956578166CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956578364CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956578715CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956578739CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956578876CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956580046CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956580060CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956580237CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956581258CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956581463CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956581487CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956583573CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956583641CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956583856CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-04
10198956520790CARDINAL HEALTHCardinal Health 200, LLCLRP2026-08-26
10198956521001CARDINAL HEALTHCardinal Health 200, LLCLRP2026-08-26
10198956568228CARDINAL HEALTHCardinal Health 200, LLCLRP2026-08-26
10198956569348CARDINAL HEALTHCardinal Health 200, LLCLRP2026-08-26
10198956569843CARDINAL HEALTHCardinal Health 200, LLCLRP2026-08-26