Identity
- Trade Name
- Greenwald Surgical Company, Inc. FDA UDI
- Generic Name
- Urethral sound, reusable FDA UDI
- Device Name
- Walther sound, curved, 1-34" nominal bend height. Features proximal taper to relax the penile meatus. Mirror finish, stainless steel, precision machined. FDA UDI
- Model / Reference
- 58190-28 FDA UDI
- Description
- Walther sound, curved, 1-34" nominal bend height. Features proximal taper to relax the penile meatus. Mirror finish, stainless steel, precision machined. FDA UDI
Identifiers
- Catalog Number
- U344 FDA UDI
- Primary DI / UDI-DI
- 10801334012540 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
Dimensions & Sizes
- Size
- Length — 9.5 Inch FDA UDICatheter Gauge — 28 French FDA UDI
Category: Urethral sound, reusable
Greenwald Surgical Company, Inc. by Grace Manufacturing Inc — 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
- Manufacturer
- Grace Manufacturing Inc
Sources (1)
- FDA UDI 8fe55d8b-f8f8-456e-b836-101109238018 35 fields · synced Jun 1, 2026