Identity
- Trade Name
- Integra® Jarit® FDA UDI
- Generic Name
- Urethral sound, reusable FDA UDI
- Device Name
- Integra® Jarit® Walther Female Dilator-Catheter, 5-3/8", 22 French FDA UDI
- Model / Reference
- X304433 FDA UDI
- Description
- Integra® Jarit® Walther Female Dilator-Catheter, 5-3/8", 22 French FDA UDI
Identifiers
- Catalog Number
- X304433 FDA UDI
- Primary DI / UDI-DI
- 10381780406532 FDA UDI
- FDA Product Code
- FBX FDA UDI
- GMDN Term
- Urethral sound, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.5520 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Catheter Gauge — 22 French FDA UDI
Category: Urethral sound, reusable
Integra Jarit Walther Female Dilator-Catheter is a medical device designed to explore and measure the urethra, a slender hollow or solid cylindrical instrument made of metal or plastic. It is typically available in a range of sizes and flexibilities.
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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
- Manufacturer
- Integra LifeSciences Production Corporation
Sources (1)
- FDA UDI 34096364-048a-4ffd-ac8b-7f3b99865357 37 fields · synced Jun 22, 2026