Identity
- Trade Name
- Vistec FDA UDI
- Generic Name
- Radiopaque woven surgical sponge FDA UDI
- Device Name
- X-Ray Detectable Sponges,Round Cotton-filled, X-Large FDA UDI
- Model / Reference
- 6449 FDA UDI
- Description
- X-Ray Detectable Sponges,Round Cotton-filled, X-Large FDA UDI
Identifiers
- Catalog Number
- 6449 FDA UDI
- Primary DI / UDI-DI
- 10884527016914 FDA UDI
- FDA Product Code
- GDY FDA UDI
- GMDN Term
- Radiopaque woven surgical sponge FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4450 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 1.625 Inch FDA UDI
Category: Radiopaque woven surgical sponge
Vistec by Cardinalhealth — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Radiopaque woven surgical sponge.
- SurgiCount Safety-Sponge — Stryker Corp. · Class I
- DuLap® — Derma Sciences Canada, Inc · Class I
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- ORLocate — STERIS CORPORATION · Class I
- MEDLINE — MEDLINE INDUSTRIES, INC. · Class I
- AMD-RITMED — AMD Medicom Inc · Class I
- Dukal — Dukal LLC · Class I
- HCS — DYAD MEDICAL SOURCING, LLC · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cardinalhealth
Sources (1)
- FDA UDI 027a3ca1-be30-4a1b-a501-61ad829f0a11 37 fields · synced Jun 1, 2026