Identity
- Trade Name
- HYGITECH FDA UDI
- Generic Name
- Moist-cold pack FDA UDI
- Device Name
- This reusable Hot & Cold therapy pack helps patients manage pain and swelling following implantology procedures. - Sized 10 x 11.5 cm, it offers full coverage of the surgical area. - Easy to store and use: Simply store in a freezer until ready to use - Comfortable thanks to its non-woven cover - To administer heat: simply place in the microwave for twice 15 seconds to heat up FDA UDI
- Model / Reference
- HY-301 FDA UDI
- Description
- This reusable Hot & Cold therapy pack helps patients manage pain and swelling following implantology procedures. - Sized 10 x 11.5 cm, it offers full coverage of the surgical area. - Easy to store and use: Simply store in a freezer until ready to use - Comfortable thanks to its non-woven cover - To administer heat: simply place in the microwave for twice 15 seconds to heat up FDA UDI
Identifiers
- Catalog Number
- HY-301 FDA UDI
- Primary DI / UDI-DI
- 03615140000420 FDA UDI
- FDA Product Code
- IMD FDA UDI
- GMDN Term
- Moist-cold pack FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.5710 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: Moist-cold pack
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 cd7f0e05-b71f-45fb-bb01-0710e7a4adbd 34 fields · synced May 31, 2026