Identity
- Trade Name
- Forsure FDA UDI
- Generic Name
- Surgical cap, single-use FDA UDI
- Device Name
- A non-sterile head covering designed as a cap intended to be worn by surgical staff during an operation to protect both the patient and themselves from the transfer of microorganisms, body fluids, and particulate material. It is usually made of reinforced paper or non-woven materials. This is a single-use device. FDA UDI
- Model / Reference
- 16300024 FDA UDI
- Description
- A non-sterile head covering designed as a cap intended to be worn by surgical staff during an operation to protect both the patient and themselves from the transfer of microorganisms, body fluids, and particulate material. It is usually made of reinforced paper or non-woven materials. This is a single-use device. FDA UDI
Identifiers
- Catalog Number
- 16300024 FDA UDI
- Primary DI / UDI-DI
- 00897633001654 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
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
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
Yes
FDA UDI
Category: Surgical cap, single-use
Forsure by Forsure Medical Products Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- 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 |
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Manufacturer
- Manufacturer
- Forsure Medical Products Llc
Sources (1)
- FDA UDI 579f932d-d19a-4e95-ac90-2c533e22620b 36 fields · synced May 30, 2026