FDA.reportPublic FDA data

SME

Primary DI
00851004007126
Brand
SME
Company
SME, INC. USA
Model
SMEG
Catalog number
SMEG
Device description
Economy Ultrasound Gel 5 Liter
Published
2016-10-31
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MUIMedia,Coupling,Ultrasound

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MUIMedia, Coupling, UltrasoundRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851004007126PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851004007126008510040071268510040071260851004007126

GMDN Terms#

Term, Definition table
TermDefinition
Coupling gel, non-sterileA non-sterile medium designed to be applied to a patient's unbroken skin surface to provide a coupling between an analytical device (e.g., ultrasound transducer, optical glucose monitoring system) and the patient, allowing for the emission and reception of signals (e.g., ultrasound, light) that pass through the skin during an examination. It is in the form of a non-sticky, fluid-like gel that may also assists the operator's ability to move the analytical device smoothly over the skin to better analyse the site of interest. It may be used by a healthcare professional or layperson. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume5Liter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature50 Degrees Fahrenheit80 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
910-798-0500ordernow@smeincusa.com

Regulatory Flags#

DUNS number
008264868
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10851004007000SMEW100W1002017-03-01
10851004007017SMEW102W1022017-03-01
10851004007024SMEW104W1042017-03-01
10851004007031SMEW106W1062017-03-01
10851004007048SMEW110W1102017-03-01
10851004007055SMEW116W1162017-03-01
10851004007062SMEF202F2022017-03-01
10851004007079SMEF204F2042017-03-01
10851004007086SMEF206F2062017-03-01
10851004007093SMEF210F2102017-03-01
00851004007133SMESMELSMEL2018-05-30
00851004007140SMESMEGSMEG2018-05-30
00851004007157SMESMELSMEL2016-10-31

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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