FDA.report

HR Ultrasound Jelly

Primary DI
10851809002002
Brand
HR Ultrasound Jelly
Company
HR PHARMACEUTICALS INC.
Model
212ST
Catalog number
212ST
Device description
Sterile Ultrasound Gel, Safewrap
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
MUIMedia,coupling,ultrasound

Product Code Classifications

CodeDeviceSpecialtyClass
MUIMedia, Coupling, UltrasoundRadiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10851809002002PackageGS150In Commercial Distribution
20851809002009PackageGS14In Commercial Distribution
00851809002005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1085180900200210851809002002
2085180900200920851809002009
00851809002005008518090020058518090020050851809002005

GMDN Terms

TermDefinition
Coupling gel, sterileA sterile medium designed to be applied to a patient's skin surface to provide a coupling between an ultrasound transducer and the patient, allowing for the emission and reception of ultrasonic waves that pass through the skin during an ultrasound examination requiring sterile procedure. It is in the form of a non-sticky, drip resistant, fluid-like gel that has been thermally sterilized (contains no degradation products of radiation sterilization) that also assists the operator's ability to move the ultrasound transducer (probe) smoothly over the skin to better scan the site of interest. After application, this device cannot be reused.

Device Sizes

TypeValueUnit
Weight20Gram

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method
Liquid Chemical

Contacts

PhoneEmail
+1(717)252-1110chris.wiesman@hrpharma.com

Regulatory Flags

DUNS number
828918164
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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