DEVICE: exGraft (00818136020249)

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Device Record History
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Device Identifier (DI) Information
exGraft
RGX181501
In Commercial Distribution
RUX181501
PECA LABS, INC.
00818136020249
GS1

1
078340058 *Terms of Use
18mm ID x 15cm L exGraft ePTFE Vascular Graft
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Device Characteristics
MR Conditional
No
Yes
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, non-medicated
An implantable artificial substitute for a blood vessel intended to replace, bypass or shunt a portion of peripheral vasculature (excludes coronary and cerebral arteries) due to a disease, injury, or for haemodialysis access. It is made of synthetic polymer materials [e.g., woven or knitted polyethylene terephthalate (Dacron) or polytetrafluoroethylene (PTFE) fabrics]; it does not contain any pharmaceuticals and 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
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K183613 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
Lumen/Inner Diameter: 18 Millimeter
Length: 15 Centimeter
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Device Record Status
3bdd7dc6-b008-45f3-a84d-fac8b720e0e9
December 25, 2025
3
December 04, 2024
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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
00818136020768 1 00818136020249 In Commercial Distribution Outer/ Shipper Box
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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

[?]
No Customer Contact currently defined
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