Ultrasound Transmission Gel

Primary DI
17350025911660
Brand
Ultrasound Transmission Gel
Company
Vitrolife Sweden AB
Model
14203
Published
2016-09-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
JOTElectrode, Gel, Electrosurgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOTElectrode, Gel, ElectrosurgicalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K894490000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K894490000STERILE ULTRASOUND TRANSMISSION GELSwedish Trade Council USA1989-10-05JOT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17350025911660PrimaryGS10
07350025911663Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1735002591166017350025911660
07350025911663073500259116637350025911663

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
631805488
Device count
25
Lot or batch
true
Expiration date on label
true

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07350025910307OVOIL100292016-09-13
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07350025911618Ultrasound Transducer Cover142212025-04-16
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17350025911615Ultrasound Transducer Cover142212025-04-16
17350025911622Ultrasound Transducer Cover142202025-04-16
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17350025910274ICSI101112016-09-13
17350025914784SpermGrad101382016-09-13
17350025914791SpermGrad101392016-09-13
07350025910017ASP101002016-09-13