FDA.reportPublic FDA data

SteriBest

Primary DI
00810142754330
Brand
SteriBest
Company
INTERNATIONAL SURGICAL PRODUCTS INC
Model
43-055396
Device description
"FINE MESH TRAY W/ LID, 11"" x 6.75"" x 1.5"""
Published
2023-09-12
Public version status
Update
Distribution status
Not 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
00810142754330PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810142754330008101427543308101427543300810142754330

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
197053028
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810129330007SteriBestSTBS-62023-01-10
00810129330014SteriBestSTBS-82023-01-10
00810129330021SteriBestSTCL-102023-01-10
00810129330038SteriBestSTCL-122023-01-10
00810129330045SteriBestSTCL-142023-01-10
00810129330052SteriBestSTCL-162023-01-10
00810129330069SteriBestSTCL-182023-01-10
00810129330076SteriBestSTCL-62023-01-10
00810129330083SteriBestSTCL-82023-01-10
00810129330090SteriBestSTCL55-102023-01-10
00810129330106SteriBestSTCL55-122023-01-10
00810129330113SteriBestSTCL55-142023-01-10
00810129330120SteriBestSTCL55-162023-01-10
00810129330137SteriBestSTCL55-62023-01-10
00810129330144SteriBestSTCL55-82023-01-10
00810129330151SteriBestSTPS-102023-01-10
00810129330168SteriBestSTPS-122023-01-10
00810129330175SteriBestSTPS-62023-01-10
00810129330182SteriBestSTPS-82023-01-10
00810129330199SteriBestSTPS25-102023-01-10

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Primary DI, Brand, Company table
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