FDA.reportPublic FDA data

SteriBest

Primary DI
00642356003221
Brand
SteriBest
Company
Mastel Surgical Inc.
Model
PR-L0944-5
Catalog number
80.PR-L0944-5
Device description
"POUCH RACK LOOP STYLE 5 SLOT 1.625"" SPACING 8.7 X 4 X 4"
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
MDMInstrument, Manual, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00642356003221PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00642356003221006423560032216423560032210642356003221

GMDN Terms#

Term, Definition table
TermDefinition
Sterilizer/disinfector rackA non-sterile rack or group of shelves intended to hold medical devices in a sterilizer or chemical washer/disinfector during the sterilization or washing/disinfection cycle. It may also be used to transport medical devices to and from the process and for their temporary storage. This is a reusable device.

Regulatory Flags#

DUNS number
789897865
Device count
1
Premarket exempt
true
Lot or batch
true

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
00190776436834MillenniumAvalign Technologies, Inc.MDM2026-10-22
07540277009663RMAC Surgical MarkerRMAC Surgical, IncMDM2026-10-21
00190776435080MillenniumAvalign Technologies, Inc.MDM2026-10-15
00840456225332JMUJMU DENTAL, INCMDM2026-10-13
00840456225349JMUJMU DENTAL, INCMDM2026-10-13
06955045515634hoboatJiangsu Hope Biomedical Science&Technology Co.,Ltd.MDM2026-10-13
06955045515689hoboatJiangsu Hope Biomedical Science&Technology Co.,Ltd.MDM2026-10-13
00190776434120MillenniumAvalign Technologies, Inc.MDM2026-10-09
00190776434229MillenniumAvalign Technologies, Inc.MDM2026-10-09
00190776433840MillenniumAvalign Technologies, Inc.MDM2026-10-08
00190776433857MillenniumAvalign Technologies, Inc.MDM2026-10-08
00190776433673MillenniumAvalign Technologies, Inc.MDM2026-10-07
00190776436162MillenniumAvalign Technologies, Inc.MDM2026-10-07
G141526051160Carnegie Surgical LLCCarnegie Surgical LLCMDM2026-10-07
00190776433536MillenniumAvalign Technologies, Inc.MDM2026-10-06
00190776434311MillenniumAvalign Technologies, Inc.MDM2026-10-06
00810220800584Adler Instrument CompanyAdler, Inc.MDM2026-09-30
00190776432775MillenniumAvalign Technologies, Inc.MDM2026-09-29
00888867618961Arthrex®ARTHREX, INC.MDM2026-09-28
00888867621237Arthrex®ARTHREX, INC.MDM2026-09-28
10888277689251MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689268MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689282MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689299MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689305MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689312MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689329MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689336MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689343MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689350MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28