Identity
- Trade Name
- Lead Loop FDA UDI
- Generic Name
- Multi-purpose surgical adhesive tape, sterile FDA UDI
- Device Name
- Suture Concepts Trail Lead Fixation Device FDA UDI
- Model / Reference
- CAT-TFD-10 FDA UDI
- Description
- Suture Concepts Trail Lead Fixation Device FDA UDI
Identifiers
- Catalog Number
- CAT-TFD-10 FDA UDI
- Primary DI / UDI-DI
- M759CATTFD01 FDA UDI
- FDA Product Code
- KGX FDA UDI
- GMDN Term
- Multi-purpose surgical adhesive tape, sterile 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
Yes
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Category: Multi-purpose surgical adhesive tape, sterile
Lead Loop by Suture Concepts Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multi-purpose surgical adhesive tape, sterile.
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
- Suture Concepts Inc.
Sources (1)
- FDA UDI 109a06cc-1145-4715-b9d1-a08494de868c 35 fields · synced Jun 8, 2026