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TruFire™
FDA UDIClass I (US FDA UDI)
by T.a.g Medical Products Agricultural Cooperative Association
Identity
- Trade Name
- TruFire™ FDA UDI
- Generic Name
- Suturing needle, single-use FDA UDI
- Device Name
- TruFire™ Suture Passer Needle FDA UDI
- Model / Reference
- TF-N FDA UDI
- Description
- TruFire™ Suture Passer Needle FDA UDI
Identifiers
- Catalog Number
- 382200cn FDA UDI
- Primary DI / UDI-DI
- 30810128460607 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Suturing needle, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
Radiation Sterilization FDA UDI
Category: Suturing needle, single-use
TruFire™ by T.a.g Medical Products Agricultural Cooperative Association — 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
Sources (1)
- FDA UDI 8a90c228-b3bf-4d54-a4f4-7c1520b6b147 34 fields · synced May 30, 2026