FDA.report

WINNER EVO PACKAGE

Primary DI
00850958007619
Brand
WINNER EVO PACKAGE
Company
Compass Richmar, LLC
Model
410-010
Device description
CM2, 5CM, 2X2 MS CLOTH, LEAD CORDS, 5CM GELSHOTS & ADAPTOR
Published
2016-11-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
MUIMedia,Coupling,Ultrasound

Product Code Classifications

CodeDeviceSpecialtyClass
MUIMedia, Coupling, UltrasoundRadiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850958007619PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850958007619008509580076198509580076190850958007619

GMDN Terms

TermDefinition
Coupling gel disk holderA non-sterile device intended to hold a coupling gel disk (not included) over the distal end of a noninvasive therapeutic ultrasound system applicator during treatment. It is typically a small attachment with a window designed to support the coupling gel disk in place while not obstructing transmission of ultrasound. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
1-888-459-4945customerservice@richmarweb.com
800-376-7263customerservice@compasshealthbrands.com

Regulatory Flags

DUNS number
080930531
Device count
1
DM exempt
false
Premarket exempt
false
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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10850689007404STICK-E-PADS203-6772016-11-18
10850689007428ValueStim202-6752016-11-18
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10850689007466Adhesive Electrodes202-4542016-11-18
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