Identity
- Trade Name
- DigniCap FDA UDI
- Generic Name
- Scalp cooling system, hair loss FDA UDI
- Model / Reference
- S1 FDA UDI
Identifiers
- Catalog Number
- REF 13400 FDA UDI
- Primary DI / UDI-DI
- 07350002100042 FDA UDI
- GMDN Term
- Scalp cooling system, hair loss FDA UDI
Classification
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Depth — 199.4 Millimeter FDA UDIWidth — 186.6 Millimeter FDA UDIHeight — 150.3 Millimeter FDA UDI
DigniCap by Dignitana AB — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Dignitana AB
Sources (1)
- FDA UDI 8d58e98e-20ff-43d9-8bbb-807be9360675 36 fields · synced May 31, 2026