Identity
- Trade Name
- FasTac® Flex FDA UDI
- Generic Name
- Epicardial pacing lead inserter FDA UDI
- Device Name
- Steerable Lead Implant Tool FDA UDI
- Model / Reference
- 201600-105 FDA UDI
- Description
- Steerable Lead Implant Tool FDA UDI
Identifiers
- Catalog Number
- 6201 FAS FDA UDI
- Primary DI / UDI-DI
- 00821329001666 FDA UDI
- FDA Product Code
- DWS FDA UDI
- GMDN Term
- Epicardial pacing lead inserter 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: Epicardial pacing lead inserter
FasTac® Flex by Greatbatch Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Epicardial pacing lead inserter.
- FasTac® Flex — Greatbatch Ltd · Class I
- FasTac® Flex — Greatbatch Ltd · Class I
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
- Greatbatch Ltd
Sources (1)
- FDA UDI b4ab92b8-2b86-4747-81a6-1f559377fe45 34 fields · synced May 30, 2026