Identity
- Trade Name
- HYGITECH FDA UDI
- Generic Name
- Medical equipment/instrument drape, single-use FDA UDI
- Device Name
- HYGITECH header cover in polyethylene enables you to cover the armchair header in your dental practice. It can also cover the x-ray tube. It is an effective barrier to fight against cross contaminations. Practical: easily separated one from the other through the dispenser box. Resistant Easy to set up The head cover must to be changed after every patient. Dimensions: 23cm large x 30cm long FDA UDI
- Model / Reference
- HY-064 FDA UDI
- Description
- HYGITECH header cover in polyethylene enables you to cover the armchair header in your dental practice. It can also cover the x-ray tube. It is an effective barrier to fight against cross contaminations. Practical: easily separated one from the other through the dispenser box. Resistant Easy to set up The head cover must to be changed after every patient. Dimensions: 23cm large x 30cm long FDA UDI
Identifiers
- Catalog Number
- HY-064 FDA UDI
- Primary DI / UDI-DI
- 03615140002875 FDA UDI
- FDA Product Code
- FXP 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
No
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 7089d5a6-3609-43f2-97a0-6be3b8e626d3 34 fields · synced Jun 8, 2026