Identity
- Trade Name
- Copioumed FDA UDI
- Generic Name
- Surgical cap, single-use FDA UDI
- Device Name
- Copioumed Surgical Cap with Ties offers a comfortable and enhanced fit for wearers, as it is equipped with ties on the back for an adjustable size. The wide-forehead surgical cap’s design also ensures a close fit, especially for people with long hair. In addition, the wide and flat forehead contains no elastic, so this surgical cap won’t leave a mark. Which offers protection against particles- and hair-related cross-contamination, making it the preferred line for the operating theatre. FDA UDI
- Model / Reference
- SCN0B201-1 FDA UDI
- Description
- Copioumed Surgical Cap with Ties offers a comfortable and enhanced fit for wearers, as it is equipped with ties on the back for an adjustable size. The wide-forehead surgical cap’s design also ensures a close fit, especially for people with long hair. In addition, the wide and flat forehead contains no elastic, so this surgical cap won’t leave a mark. Which offers protection against particles- and hair-related cross-contamination, making it the preferred line for the operating theatre. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719882250477 FDA UDI
- FDA Product Code
- FYF FDA UDI
- GMDN Term
- Surgical cap, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4040 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
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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
Copioumed by Copioumed International Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
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Manufacturer
- Manufacturer
- Copioumed International Inc.
Sources (1)
- FDA UDI 61ef8970-243d-42e0-bc91-d30f8f3244c1 35 fields · synced May 29, 2026