Vein Distention

Primary DI
00803622133121
Brand
Vein Distention
Company
LIVANOVA USA, INC.
Model
300
Published
2016-08-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DWPDILATOR, VESSEL, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWPDilator, Vessel, SurgicalCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K792134000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K792134000BONCHEK-SHILEY VEIN DISTENTION SYSTEMShiley, Inc.1979-12-04DWP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10803622133128PackageGS15In Commercial Distribution
00803622133121PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080362213312810803622133128
00803622133121008036221331218036221331210803622133121

GMDN Terms#

Term, Definition table
TermDefinition
Vascular dilator, reusableA hand-held surgical instrument designed for insertion into a blood vessel (the vasculature) to unblock, enlarge or measure the internal diameter of the vessel during a surgical intervention. It is a rod-like device with a long, slender, body that terminates with a bulbous, cylindrical distal tip of various shapes and sizes. Commonly known as a vessel dilator or vascular probe, it is available in a variety of sizes (diameters and lengths) and flexibilities. It is typically made of metal or plastic materials. This is a reusable device.

Regulatory Flags#

DUNS number
080914995
Device count
1
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

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