Identity
- Trade Name
- TITAN™ DOUBLE WIRE FDA UDI
- Generic Name
- Metallic suture, monofilament FDA UDI
- Device Name
- MONOFILAMENT 316 LVM STAINLESS STEEL SUTURE, MC2 NEEDLE, 59MM, USP 6, 14", 2 PK FDA UDI
- Model / Reference
- 132.645.52 FDA UDI
- Description
- MONOFILAMENT 316 LVM STAINLESS STEEL SUTURE, MC2 NEEDLE, 59MM, USP 6, 14", 2 PK FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00853190008116 FDA UDI
- FDA Product Code
- PTX FDA UDI
- GMDN Term
- Metallic suture, monofilament FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4495 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
MR Conditional FDA UDI
Titan™ Double Wire by Jace Medical, Llc — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Jace Medical, Llc
Sources (1)
- FDA UDI 695b297f-b0d5-464b-a280-5a1d239e212a 35 fields · synced Jun 8, 2026