Identity
- Trade Name
- CARDIOXYL ® FDA UDI
- Generic Name
- Polyester suture, non-bioabsorbable, multifilament FDA UDI
- Model / Reference
- 73P10A FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03661522020326 FDA UDI
- 510(k) Number
- K060163 FDA UDI
- FDA Product Code
- GAT FDA UDI
- GMDN Term
- Polyester suture, non-bioabsorbable, multifilament FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.5000 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
No
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 Safe FDA UDI
Category: Polyester suture, non-bioabsorbable, multifilament
Cardioxyl ® by Peters Surgical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Polyester suture, non-bioabsorbable, multifilament.
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- ETHIBOND EXCEL — Ethicon Inc. · Class II
- DemeBOND — DemeTECH Corp · Class II
- DEKNATEL — TELEFLEX INCORPORATED · Class II
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- DEKNATEL — TELEFLEX INCORPORATED · Class II
Cleared under the same submission
K060163 also covers:
- CARDIOXYL ® — PETERS SURGICAL
- CARDIOXYL ® — PETERS SURGICAL
- CARDIOXYL ® — PETERS SURGICAL
- CARDIOXYL ® — PETERS SURGICAL
- CARDIOXYL ® — PETERS SURGICAL
- CARDIOXYL ® — PETERS SURGICAL
- CARDIOXYL ® — PETERS SURGICAL
- CARDIOXYL ® — PETERS SURGICAL
- CARDIOXYL ® — PETERS SURGICAL
- CARDIOXYL ® — PETERS SURGICAL
- CARDIOXYL ® — PETERS SURGICAL
- CARDIOXYL ® — PETERS SURGICAL
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Peters Surgical
Sources (1)
- FDA UDI 3ada5f48-c0d3-4e8c-9224-b6e3206090ae 33 fields · synced May 30, 2026