FDA.report

CelluShape4D

Primary DI
08033945934583
Brand
CelluShape4D
Company
QUANTA SYSTEM SPA
Model
PZMS00009
Published
2016-08-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
ISAMassager, Therapeutic, Electric

Product Code Classifications

CodeDeviceSpecialtyClass
ISAMassager, Therapeutic, ElectricPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08033945934583PrimaryGS10

Alternate GTIN/UPC/EAN values are derived from GS1 digit structure for lookup convenience. Do not treat derived UPC-A or EAN-13 values as separate FDA identifiers. GTIN-14 values with indicator digits 1-9 usually represent packaging levels, cases, pallets, or variable-measure items and are not converted to UPC-A/EAN-13 here.

Alternate GTIN / UPC / EAN Codes

Source identifierSource lengthGTIN-14 normalizedIndicatorEAN-13Conversion note
08033945934583140803394593458308033945934583Indicator 0 allows EAN-13 conversion; UPC-A requires prefix 00.

GMDN Terms

TermDefinition
Hand-held electric massagerAn electrically-powered device with a vibrating head, or pads, designed to be held in the hand and drawn across the area of the body/muscles to be treated. The vibrating head, or pads, may optionally be heated, and may be interchangeable with others of different size and shape. It is typically used for respiratory therapy or physiotherapy (e.g., help reduce muscular tension, arthritic pain or joint mobility) in the home and/or healthcare facility.

Sterilization Methods

Method

Regulatory Flags

DUNS number
436045833
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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08033945938369Litho 100PVMS000552018-05-17
08059173395491Optical Fiber Reusable 10xUL200R2022-12-22
08059173395521Optical Fiber Reusable 10xUL272R2022-12-22
08059173395552Optical Fiber Reusable 10xUL365R2022-12-22
08059173395583Optical Fiber Reusable 10xUL550R2022-12-22
08059173395613Optical Fiber Reusable 10xUL800R2022-12-22
08059173395644Optical Fiber Reusable 10xUL999R2022-12-22
08059173396368DualityPCMS003542023-05-10
08033945937515MH01PVMS000542017-10-09
08059173392230Accure PFMS000042022-12-01

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