FDA.reportPublic FDA data

Storz Ophthalmic Instruments

Primary DI
00850017474482
Brand
Storz Ophthalmic Instruments
Company
INTERNATIONAL SURGICAL PRODUCTS INC
Model
CP634-SB
Catalog number
E7409
Device description
"STERILIZATION TRAY 4"" X 6.5"""
Published
2021-08-03
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00850017474482PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850017474482008500174744828500174744820850017474482

GMDN Terms#

Term, Definition table
TermDefinition
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
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
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04052536164608neon3Ulrich GmbH & Co. KGLRP2026-06-09
04052536177516neon3Ulrich GmbH & Co. KGLRP2026-06-09
04052536221202uCentumUlrich GmbH & Co. KGLRP2026-06-09
04052536221219uCentumUlrich GmbH & Co. KGLRP2026-06-09
04052536221233uCentumUlrich GmbH & Co. KGLRP2026-06-09
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
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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
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10198956501362CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956505841CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956506381CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08