Identity
- Trade Name
- exGraft FDA UDI
- Generic Name
- Synthetic vascular graft FDA UDI
- Device Name
- 4mm ID x 25cm Length exGraft ePTFE vascular graft FDA UDI
- Model / Reference
- RGX042501 FDA UDI
- Description
- 4mm ID x 25cm Length exGraft ePTFE vascular graft FDA UDI
Identifiers
- Catalog Number
- RUX042501 FDA UDI
- Primary DI / UDI-DI
- 00818136022335 FDA UDI
- FDA Product Code
- DYF FDA UDI
- GMDN Term
- Synthetic vascular graft FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.3450 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Length — 25 Centimeter FDA UDILumen/Inner Diameter — 4 Millimeter FDA UDI
Category: Synthetic vascular graft
exGraft by Peca Labs, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- ADVANTA SLIDER GDS — Atrium Medical Corp. · Class II
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Peca Labs, Inc.
Sources (1)
- FDA UDI cfd2af84-fe67-4dd7-ac96-1890d8876ecb 35 fields · synced May 30, 2026