DEVICE: ADVANTA SLIDER GDS (00650862221145)

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Device Record History
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Device Identifier (DI) Information
ADVANTA SLIDER GDS
22114
In Commercial Distribution

Atrium Medical Corporation
00650862221145
GS1

1
051798999 *Terms of Use
4-6MMX45CM, SW, SH, ADVANTA VXT, GDS
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
35281 Synthetic vascular graft
An implantable artificial substitute for a blood vessel intended to replace or bypass a diseased or injured vessel, typically the aorta, an iliac, a femoral or popliteal artery; it is not intended for use in the coronary arteries. It is typically made of woven or knitted polyethylene terephthalate (Dacron) or polytetrafluoroethylene (PTFE) fabrics; it does not incorporate a metallic mesh (i.e., it is not a stent-graft).
Active true
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FDA Product Code

[?]
Product Code Product Code Name
DSY PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
DYF PROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER
DWS INSTRUMENTS, SURGICAL, CARDIOVASCULAR
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

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

[?]
Storage and Handling
Storage Environment Temperature: between 59 and 77 Degrees Fahrenheit
Storage Environment Humidity: between 0 and 80 Percent (%) Relative Humidity
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
a7359c8f-f447-4c4b-9589-83074a2b5f54
September 24, 2025
6
September 24, 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

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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

[?]
No
Yes
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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