FDA.reportPublic FDA data

SteriBest

Primary DI
00850017474147
Brand
SteriBest
Company
INTERNATIONAL SURGICAL PRODUCTS INC
Model
CP634-SB
Catalog number
CP634-SB
Device description
INSTRUMENT TRAY ASSEMBLY 6.5 X 4 X .75 CONSISTS OF LID, SLOTTED BASE, MAT
Published
2021-05-28
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
00850017474147PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850017474147008500174741478500174741470850017474147

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing clinical instruments (typically endoscopes or surgical instruments) for use during a clinical procedure; it might in addition be used during, but not dedicated to, reprocessing/sterilization procedures. It is typically in the form of a shallow vessel with a raised rim, a deeper cassette-like device, or a flat or angled surface; it might include a lid. It may be designed to fit into other devices such as supply trolleys, storage systems and sterilizers, or designed to attach to a surgical/treatment table where it may be placed over the patient. 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
Manufacturing date on label
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07649988948725SPIRECUTSPIRECUT SALRP2026-05-04
G586961003A0Novo SurgicalNOVO SURGICAL, INC.LRP2024-02-22
G429MSS820160Stainless steel bowl small 6CMMEED SKILL SURGICALLRP2023-03-03
G141588222990Carnegie Surgical LLCCarnegie Surgical LLCLRP2023-02-13
07899798205796QuinelatoSchobell Industrial LtdaLRP2022-12-20
10080196055159MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10080196818778MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10080196848041MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10080196996681MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10190001934897MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489190021MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489190076MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489190137MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489190304MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489190342MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489190380MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489190489MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489190564MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489191066MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489191073MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489191080MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489191097MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489191103MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489191141MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489191189MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489191240MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489190199MEDLINEMEDLINE INDUSTRIES, INC.LRP2021-12-16
10193489190205MEDLINEMEDLINE INDUSTRIES, INC.LRP2021-12-16
10193489190212MEDLINEMEDLINE INDUSTRIES, INC.LRP2021-12-16
10193489190250MEDLINEMEDLINE INDUSTRIES, INC.LRP2021-12-16