Identity
- Trade Name
- HYGITECH FDA UDI
- Generic Name
- Medical equipment/instrument drape, single-use FDA UDI
- Device Name
- Astronaut cap HYGITECH Reference: HY-50018 Ultimate protection: - Recommended for long or high-risk surgeries - It holds back loose hair and is ideal for medium to long hair - Fixes with 2 non-woven ties for the best protection and comfort - Only the face remains uncovered, head, neck and ears are protected FDA UDI
- Model / Reference
- HY-50018 FDA UDI
- Description
- Astronaut cap HYGITECH Reference: HY-50018 Ultimate protection: - Recommended for long or high-risk surgeries - It holds back loose hair and is ideal for medium to long hair - Fixes with 2 non-woven ties for the best protection and comfort - Only the face remains uncovered, head, neck and ears are protected FDA UDI
Identifiers
- Catalog Number
- HY-50018 FDA UDI
- Primary DI / UDI-DI
- 03615140003568 FDA UDI
- FDA Product Code
- FYF FDA UDI
- GMDN Term
- Medical equipment/instrument drape, 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Medical equipment/instrument drape, single-use
Hygitech by Hygitech — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Hygitech
Sources (1)
- FDA UDI c40c29d3-89d1-4f20-8fa3-7e3e03fab24b 34 fields · synced Jun 8, 2026