FDA.reportPublic FDA data

STERILIZABLE HANDLE FOR UNICA/U29

Primary DI
B880Z40030740
Brand
STERILIZABLE HANDLE FOR UNICA/U29
Company
RIMSA P. LONGONI SRL
Model
Z400307-4
Published
2020-10-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FTALight, Surgical, Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTALight, Surgical, AccessoriesGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B880Z40030740PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment handle cover, reusableA device designed specifically to cover the handle of a piece of medical equipment (e.g., operating light) to provide a physical sterile barrier between the handle and the hand of a healthcare professional, e.g., during a surgical procedure. It is typically a rigid polymer device designed for attachment to a handle and may in addition provide grip for improved manipulation of the handle; it is not designed to cover other equipment components. This is a reusable device intended to be sterilized prior to use.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature-15 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
630534840
Device count
1
DM exempt
true
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B880Z40034940STERILIZABLE HANDLE TVCC FOR UNICA/U29Z400349-42020-10-19
B880Z40046040STERILIZABLE HANDLE TVCC PREDISPOSITION FOR UNICA/U29Z400460-42020-10-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00748426145027NAMicrotek Medical LLCFTA2026-02-05
20748426262704Medline-MicrotekMicrotek Medical LLCFTA2026-01-05
80080196761844MEDLINEMEDLINE INDUSTRIES, INC.FTA2025-11-04
10724995245457HexaLuxSTERIS CORPORATIONFTA2025-05-05
20885380184113CARDINAL HEALTHCardinal Health 200, LLCFTA2023-12-28
20885380184120CARDINAL HEALTHCardinal Health 200, LLCFTA2023-12-28
20885380184137CARDINAL HEALTHCardinal Health 200, LLCFTA2023-12-28
50885380184787CARDINAL HEALTHCardinal Health 200, LLCFTA2023-12-28
00724995203399NASTERIS CORPORATIONFTA2023-11-17
10197344006915MedlineMEDLINE INDUSTRIES, INC.FTA2023-11-05
50885380183001CARDINAL HEALTHCardinal Health 200, LLCFTA2023-08-11
50885380182998CARDINAL HEALTHCardinal Health 200, LLCFTA2023-08-11
16931918117362AllesetGRI Medical & Electronic Technology Co., Ltd.FTA2023-07-20
16931918159256AllesetGRI Medical & Electronic Technology Co., Ltd.FTA2022-11-26
16931918133201AllesetGRI Medical & Electronic Technology Co., Ltd.FTA2022-11-22
16931918196565AllesetGRI Medical & Electronic Technology Co., Ltd.FTA2022-11-22
00748426118526Skytron Lite-LokMicrotek Medical LLCFTA2022-08-08
10193489003093MEDLINE INDUSTRIESMEDLINE INDUSTRIES, INC.FTA2021-11-03
10193489003109MEDLINE INDUSTRIESMEDLINE INDUSTRIES, INC.FTA2021-11-03
10193489005875MEDLINE INDUSTRIESMEDLINE INDUSTRIES, INC.FTA2021-11-03
00749756725538DeRoyalDEROYAL INDUSTRIES, INC.FTA2021-08-23
G018DLH010Physician's ChoiceSupply Line International Medical, LLCFTA2021-08-05
10850009233018SurgiLight Adapter - AIM-100BihlerMed, L.L.C.FTA2021-06-02
16931918155524AllesetGRI Medical & Electronic Technology Co., Ltd.FTA2021-04-22
16931918167046AllesetGRI Medical & Electronic Technology Co., Ltd.FTA2021-04-22
16931918173153AllesetGRI Medical & Electronic Technology Co., Ltd.FTA2021-04-22
16931918127309AllesetGRI Medical & Electronic Technology Co., Ltd.FTA2021-03-08