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Delta-Rol®
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 72310-04Ref 72310-02Ref 72310-00Ref 72310-03
Identity
- Trade Name
- Delta-Rol® EUDAMEDFDA UDI
- Generic Name
- Cotton wool roll, sterile FDA UDI
- Device Name
- Delta-Rol® EUDAMEDDELTA-ROL STERILE 15CM X 3.6MTR NATURAL 20 FDA UDI
- Model / Reference
- 72310-04 EUDAMED72310-02 EUDAMED72310-00 EUDAMED72310-03 EUDAMED72707-30 FDA UDI
- Description
- DELTA-ROL STERILE 15CM X 3.6MTR NATURAL 20 FDA UDI
Identifiers
- Catalog Number
- 72707-30 FDA UDI
- Primary DI / UDI-DI
- 04042809163131 EUDAMED04042809163094 EUDAMED04042809163056 EUDAMED04042809163117 EUDAMED04042809446616 FDA UDI
- Basic UDI-DI
- 404280940038478A8 EUDAMED
- Unit of Use DI
- 04042809665772 EUDAMED04042809665758 EUDAMED04042809665734 EUDAMED04042809665765 EUDAMED
- FDA Product Code
- ITG FDA UDI
- EMDN Code
- M03050202 SYNTHETIC CAST BANDAGES AND SPLINTS EUDAMED
- GMDN Term
- Cotton wool roll, sterile FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3025 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Width — 15 Centimeter FDA UDILength — 360 Centimeter FDA UDI
Category: Cotton wool roll, sterile
Delta-Rol® by Bsn Medical, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Bsn Medical, Inc.
Sources (5)
- FDA UDI d48138b5-cb45-41ff-b2ab-e95356028813 36 fields · synced Jul 26, 2026
- EUDAMED cc3affa3-a9a9-47eb-a617-5f71a0d293c4 61 fields · synced Jun 20, 2026
- EUDAMED 42f2ddc7-6083-4c58-ba07-1c0e77cb4264 61 fields · synced Jul 12, 2026
- EUDAMED 8de4a6dc-95a9-4e5e-a8c1-5d891ca4da28 61 fields · synced Jul 14, 2026
- EUDAMED 64699157-208f-4bce-a65f-dd7c6e3766d2 61 fields · synced Jul 26, 2026