Identity
- Trade Name
- DigniCap® Delta FDA UDI
- Generic Name
- Scalp cooling system, hair loss FDA UDI
- Device Name
- Thermal Cap, Universal Size, SPU, Qty 10 FDA UDI
- Model / Reference
- 800-1004 FDA UDI
- Description
- Thermal Cap, Universal Size, SPU, Qty 10 FDA UDI
Identifiers
- Catalog Number
- 800-1004 FDA UDI
- Primary DI / UDI-DI
- 00850036106333 FDA UDI
- FDA Product Code
- PMC FDA UDI
- GMDN Term
- Scalp cooling system, hair loss FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4360 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
Yes
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Scalp cooling system, hair loss
DigniCap® Delta by Dignitana AB — 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
- Dignitana AB
Sources (1)
- FDA UDI 204a96f2-a9ec-4d7a-b2d7-71ec28f5e010 35 fields · synced Jun 8, 2026