Identity
- Trade Name
- Cotton Balls EUDAMEDFDA UDI
- Generic Name
- Cotton ball FDA UDI
- Device Name
- Cotton Balls EUDAMEDCotton Balls-Non-Strung 1/8" FDA UDI
- Model / Reference
- 31-07 EUDAMEDFDA UDI
- Description
- Cotton Balls-Non-Strung 1/8" FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10749915000688 EUDAMED20749915000685 FDA UDI
- Basic UDI-DI
- B-10749915000688 EUDAMED
- 510(k) Number
- K854714 FDA UDI
- FDA Product Code
- GDY FDA UDI
- EMDN Code
- M0299 GAUZES - OTHER EUDAMED
- GMDN Term
- Cotton ball FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4450 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Cotton Balls by American Surgical Company, LLC — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-10749915000688 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- American Surgical Company, LLC
- EUDAMED SRN
- US-MF-000007259
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED d040008a-657a-41df-ac00-64c69eb9a20d 61 fields · synced Oct 6, 2026
- FDA UDI 64fabd4a-df43-4d65-abb7-774a8ead6bc7 34 fields · synced May 30, 2026