FDA.reportPublic FDA data

RICA Surgical Products

Primary DI
00810147254668
Brand
RICA Surgical Products
Company
INTERNATIONAL SURGICAL PRODUCTS INC
Model
R648L-W
Device description
LARGE COOLING ROLLER W/WHITE HANDLE
Published
2024-12-19
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
LYGMassager, Therapeutic, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYGMassager, Therapeutic, ManualPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810147254668PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810147254668008101472546688101472546680810147254668

GMDN Terms#

Term, Definition table
TermDefinition
External manual massager, clinicalA manual (non-powered) device designed to apply external massage to a patient, by the patient, staff, or a therapist in a hospital, institution, or therapeutic treatment situation. It is intended to stimulate/massage body muscles to provide a therapeutic effect. It is typically designed to be held in the hands and is available in a variety of configurations and materials, e.g., plastic, wood, ceramics. It is available in a variety of sizes and shapes and may be a one-piece device or have interchangeable massaging components (e.g., roller heads or pads), and have a variety of massage surfaces (e.g., points, ribs, smooth). 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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