DEVICE: GRAFT SIZERS (00384401016519)

Device Identifier (DI) Information

GRAFT SIZERS
Size 24 mm - 38 mm
In Commercial Distribution

INTERVASCULAR SAS
00384401016519
GS1

1
382174019 *Terms of Use
Graft Sizers size 24 mm - 38 mm are commercially available only in Multipack configuration (box of 10 units) with the catalog number M002363200211.
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Device Characteristics

MR Safe
No
Yes
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Open-surgery vascular sizer, single-use A sterile, invasive instrument intended to be used during open vascular surgery to approximate the size of a blood vessel for selection of an appropriately sized vascular device/implant (e.g., vascular graft, emboli filter); it is not intended to obtain a precise measurement. The device typically consists of a C-shaped (half circle) sizing portion with a handle, sometimes available in a range of sizes, and is intended to size the outer diameter of the blood vessel (i.e., extraluminal sizing); it may in addition be used to size a vascular graft. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K854431 000
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Store at controlled room temperature
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: 24 mm - 38 mm
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Device Record Status

5dfa576c-00f8-498e-8431-494ac384a9b7
July 06, 2018
3
June 24, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
00384401513049 10 00384401016519 In Commercial Distribution Multipack Box of 10
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
Yes
Yes
Yes
No CLOSE

Customer Contact

[?]
+33442084646
cardiovascular.vics@getinge.com
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