DEVICE: Hemashield (00384401017820)

Device Identifier (DI) Information

Hemashield
M002020955890
In Commercial Distribution
M002020955890
INTERVASCULAR SAS
00384401017820
GS1

1
382174019 *Terms of Use
Hemashield Gold Knitted Microvel AxilloBifemoral Double Velour Vascular Graft with Graft Sizer Accessory
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Device Characteristics

MR Safe
No
Yes
Yes
Yes
No
Yes
No
No

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Fluoroscopic x-ray system video image recording unit An assembly of devices that are part of a fluoroscopic x-ray system and specifically designed to display x-ray images in real-time. It is often referred to as an x-ray imaging chain. It includes a video camera [charge-coupled device (CCD) or tube based], a video signal generator, and cabling used to convert the analogue image taken from the output raster of the x-ray image intensifier and to display it on one or more image display monitors [visual display unit (VDU)] for immediate viewing.
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FDA Product Code

[?]
Product Code Product Code Name
MAL Graft, Vascular, Synthetic/Biologic Composite
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K954848 000
No CLOSE

Sterilization

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

[?]
Storage and Handling
Special Storage Condition, Specify: Controlled Room Temperature
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Clinically Relevant Size

[?]
Size Type Text
Length: 60 Centimeter
Lumen/Inner Diameter: 8 Millimeter
Length: 100 Centimeter
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Device Record Status

a1f5192c-e227-41f2-bd3b-0c375b5fd2c2
July 06, 2018
3
November 12, 2015
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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
No Package DIs found
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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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