DEVICE: SyvekExcel Vascular Access Hemostasis System (00389142000056)

Device Identifier (DI) Information

SyvekExcel Vascular Access Hemostasis System
400-16-05
In Commercial Distribution
400-16-05
MARINE POLYMER TECHNOLOGIES, INC
00389142000056
GS1

1
809739386 *Terms of Use
SyvekExcel Vascular Access Hemostasis System consists of a kit of 1 reusable handle, 5 alcohol prep pads, 5 caps, 5 tegaderm and 5 Syvek Excel Patches. 4 kits are packaged in one case and sold as a unit.
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Device Characteristics

Labeling does not contain MRI Safety Information
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
Vascular clamp, single-use A sterile, hand-held manual surgical instrument designed to directly compress a blood vessel (vein or artery) to create a temporary haemostasis (arrest or prevention of bleeding). It typically has a self-clamping, bulldog-like or scissors-like, ring-handled design with serrated jaws; the working end has blades of various designs (e.g., straight or angled). It is available in various sizes and is typically made of plastic materials. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
DXC Clamp, Vascular
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K053300 000
No CLOSE

Sterilization

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

74c3931f-456e-4313-a997-21f1bde11b39
July 06, 2018
3
August 05, 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
10389142000053 4 00389142000056 In Commercial Distribution Case
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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
No
Yes
No
No CLOSE

Customer Contact

[?]
1-888-666-2560
pattid@webmpt.com
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