Identity
- Trade Name
- HYGITECH FDA UDI
- Generic Name
- Medical equipment/instrument drape, single-use FDA UDI
- Device Name
- The Surgical drapes consists in a protective barrier offering a resistance to bacteria penetration during dental acts and an effective fluid control system in order to reduce the risk of surgical site infection. Sterile surgical Drapes are available in order to contribute and improve the preparation of the surgical room by preventing cross-contamination. It could be placed: On the patient: to cover the patient, the operated area during the surgical operation. It could also absorb exudate during the operation. On the operating room furniture which will be used as a support for any surgical instrumentation. The device is useful to protect the patient and environment’s surgeon. FDA UDI
- Model / Reference
- HY1-630 FDA UDI
- Description
- The Surgical drapes consists in a protective barrier offering a resistance to bacteria penetration during dental acts and an effective fluid control system in order to reduce the risk of surgical site infection. Sterile surgical Drapes are available in order to contribute and improve the preparation of the surgical room by preventing cross-contamination. It could be placed: On the patient: to cover the patient, the operated area during the surgical operation. It could also absorb exudate during the operation. On the operating room furniture which will be used as a support for any surgical instrumentation. The device is useful to protect the patient and environment’s surgeon. FDA UDI
Identifiers
- Catalog Number
- HY1-630 FDA UDI
- Primary DI / UDI-DI
- 03615140003728 FDA UDI
- FDA Product Code
- KKX FDA UDI
- GMDN Term
- Medical equipment/instrument drape, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4370 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Medical equipment/instrument drape, single-use
Hygitech by Hygitech — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Hygitech
Sources (1)
- FDA UDI f8f15fff-c98c-4bfb-a19e-07b8858d0d25 34 fields · synced May 30, 2026