Identity
- Trade Name
- DARCO® MA Spacer (MIS Akin Spacer) FDA UDI
- Generic Name
- Toe separator FDA UDI
- Device Name
- 1 Set (20 Stuck/Pieces) White FDA UDI
- Model / Reference
- MAS-20 FDA UDI
- Description
- 1 Set (20 Stuck/Pieces) White FDA UDI
Identifiers
- Catalog Number
- MAS-20 FDA UDI
- Primary DI / UDI-DI
- 00609271001701 FDA UDI
- FDA Product Code
- NOC FDA UDI
- GMDN Term
- Toe separator FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.3910 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: Toe separator
DARCO® MA Spacer (MIS Akin Spacer) by Darco (Europe) GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Toe separator.
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- Antibacterial Gel Toe Spreader, Large, 6pcs/bag — SILIPOS Holding LLC · Class I
- Antibacterial Gel Toe Spreader, Medium, 6pcs/bag — SILIPOS Holding LLC · Class I
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
- Darco (Europe) GmbH
Sources (1)
- FDA UDI 72ec06d8-fa26-4c9f-864a-5d50ec0ab2c9 34 fields · synced May 30, 2026