Identity
- Trade Name
- TopCare health FDA UDI
- Generic Name
- Butterfly skin-closure adhesive strip FDA UDI
- Device Name
- Sterile Butterfly Closures, all one size, 1 3/4 IN x 3/8 IN FDA UDI
- Model / Reference
- 036800117976 FDA UDI
- Description
- Sterile Butterfly Closures, all one size, 1 3/4 IN x 3/8 IN FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00036800117976 FDA UDI
- FDA Product Code
- KGX FDA UDI
- GMDN Term
- Butterfly skin-closure adhesive strip FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.5240 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Butterfly skin-closure adhesive strip
TopCare health by Topco Associates, LLC — 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
- Topco Associates, LLC
Sources (1)
- FDA UDI 0e380408-a036-43e7-a5c3-bd3f9911835e 33 fields · synced May 30, 2026