Identity
- Trade Name
- Strados Labs FDA UDI
- Generic Name
- Skin surface device adhesive FDA UDI
- Device Name
- Patient Adhesive, SPA1, Pack of 25. The SPA1 is a medical device accessory to the Strados Wearable Device (SWD1). FDA UDI
- Model / Reference
- SPA1 FDA UDI
- Description
- Patient Adhesive, SPA1, Pack of 25. The SPA1 is a medical device accessory to the Strados Wearable Device (SWD1). FDA UDI
Identifiers
- Catalog Number
- 810-00019 FDA UDI
- Primary DI / UDI-DI
- 00850043625001 FDA UDI
- FDA Product Code
- DSH FDA UDI
- GMDN Term
- Skin surface device adhesive FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2800 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
Yes
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
Yes
FDA UDI
Category: Skin surface device adhesive
Strados Labs by Strados Labs — 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
- Strados Labs
Sources (1)
- FDA UDI 0d1a6aae-ef60-4c28-9f74-d3baceca7340 34 fields · synced May 30, 2026