Identity
- Trade Name
- TSX™ Transseptal Needle FDA UDI
- Generic Name
- Cardiac transseptal needle, single-use FDA UDI
- Model / Reference
- 00884450451748 FDA UDI
Identifiers
- Catalog Number
- M004TSXNEEDLE400 FDA UDI
- Primary DI / UDI-DI
- 00884450451748 FDA UDI
- FDA Product Code
- DRC FDA UDI
- GMDN Term
- Cardiac transseptal needle, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1390 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
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
No
FDA UDI
Category: Cardiac transseptal needle, single-use
TSX™ Transseptal Needle by Merit Medical Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiac transseptal needle, single-use.
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- SafeSharp Transseptal Needle — PPMDM · Class II
- SafeSept Blunt Needle — PPMDM · Class II
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 II | Pending data |
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Manufacturer
- Manufacturer
- Merit Medical Systems, Inc.
Sources (1)
- FDA UDI 1ee24da3-4df1-4754-9ae8-c005144a7fc9 33 fields · synced Jun 9, 2026