Identity
- Trade Name
- TopCare health FDA UDI
- Generic Name
- Skin-cover adhesive strip, antimicrobial FDA UDI
- Device Name
- Sterile, Antibacterial, Value Pack, Assorted Adhesive Bandages: Flexible Fabric: 2 IN x 4 IN (5.0 cm x 10.1 cm); 3/4 IN x 3 IN (1.9 cm x 7.6 cm). Variety Pack: Strong Strips: 1 IN x 3 1/4 IN (2.5 cm x 8.2 cm). Water Shield Plus: 1 IN x 2 1/2 IN (2.5 cm x 6.3 cm). Foam: 5/8 IN x 2 1/4 IN (1.5 cm x 5.7 cm). Water Shield Plus: 3/4 IN x 2 IN (1.9 cm x 5 cm); 1 IN x 2 1/2 IN (2.5 cm x 6.3 cm). Neon: 1 1/2 IN X 3 1/2 IN (3.8 cm X 8.8 cm); 3/4 IN X 3 IN (1.9 cm X 7.6 cm); 5/8 IN X 2 1/4 IN (1.5 cm X 5.7 cm). FDA UDI
- Model / Reference
- 036800479463 FDA UDI
- Description
- Sterile, Antibacterial, Value Pack, Assorted Adhesive Bandages: Flexible Fabric: 2 IN x 4 IN (5.0 cm x 10.1 cm); 3/4 IN x 3 IN (1.9 cm x 7.6 cm). Variety Pack: Strong Strips: 1 IN x 3 1/4 IN (2.5 cm x 8.2 cm). Water Shield Plus: 1 IN x 2 1/2 IN (2.5 cm x 6.3 cm). Foam: 5/8 IN x 2 1/4 IN (1.5 cm x 5.7 cm). Water Shield Plus: 3/4 IN x 2 IN (1.9 cm x 5 cm); 1 IN x 2 1/2 IN (2.5 cm x 6.3 cm). Neon: 1 1/2 IN X 3 1/2 IN (3.8 cm X 8.8 cm); 3/4 IN X 3 IN (1.9 cm X 7.6 cm); 5/8 IN X 2 1/4 IN (1.5 cm X 5.7 cm). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00036800479463 FDA UDI
- FDA Product Code
- KGX FDA UDI
- GMDN Term
- Skin-cover adhesive strip, antimicrobial 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Skin-cover adhesive strip, antimicrobial
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 ca020898-72c8-4188-bce3-c1618c7970be 33 fields · synced May 30, 2026