Identity
- Trade Name
- Copioumed FDA UDI
- Generic Name
- Surgical cap, single-use FDA UDI
- Device Name
- Copioumed Bouffant Cap provides an ideal headwear for a higher level of protection and comfort. The single-use cap features a latex-free elastic band around its circumference. This helps prevent allergic reactions that are due to exposure to latex . Which offers protection against particles- and hair-related cross-contamination, making it the preferred line for the operating theatre. FDA UDI
- Model / Reference
- SCN0W171-1 FDA UDI
- Description
- Copioumed Bouffant Cap provides an ideal headwear for a higher level of protection and comfort. The single-use cap features a latex-free elastic band around its circumference. This helps prevent allergic reactions that are due to exposure to latex . 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
- 04719882253485 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
- 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
No
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
Category: Surgical cap, single-use
Copioumed by Copious International Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical cap, single-use.
- Mölnlycke® — Mölnlycke Health Care AB · Class I
- GCB Medical Supply Novaplus — GCB MEDICAL LLC · Class I
- SURGICAL CAPS — Unicoglobal, Inc. · Class I
- BIEDQ — Xiantao Daoqi Plastic Co., Ltd. · Class I
- A Plus — A PLUS INTERNATIONAL, INC · Class I
- Precept® — Precept Medical Products, Inc. · Class I
- SOURCE SURGICAL INC. — KENPAX INTERNATIONAL LIMITED · Class I
- Dukal — Dukal 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
- Copious International Inc.
Sources (1)
- FDA UDI e1ab50bd-f650-4647-87ee-169d8ba5c624 34 fields · synced May 30, 2026