Identity
- Trade Name
- One-Tie FDA UDI
- Generic Name
- Pacing/defibrillation lead extraction wrap FDA UDI
- Device Name
- One-Tie Compression Coil FDA UDI
- Model / Reference
- G31929 FDA UDI
- Description
- One-Tie Compression Coil FDA UDI
Identifiers
- Catalog Number
- LR-OTE-N FDA UDI
- Primary DI / UDI-DI
- 00827002319295 FDA UDI
- FDA Product Code
- DWS FDA UDI
- GMDN Term
- Pacing/defibrillation lead extraction wrap FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 870.4500 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Pacing/defibrillation lead extraction wrap
One-Tie by Cook Vandergrift Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Cook Vandergrift Inc.
Sources (1)
- FDA UDI 056bbddd-450a-4ecf-af9a-7492af07ff37 36 fields · synced May 30, 2026