FDA UDI
In Commercial Distribution
🇺🇸 United States
Greenwald Surgical Company, Inc.
DI: 10801334012540
·
Model: 58190-28
·
GRACE MANUFACTURING, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Greenwald Surgical Company, Inc.
- Primary DI
- 10801334012540
- Version / Model
- 58190-28
- Catalog Number
- U344
- Company Name
- GRACE MANUFACTURING, INC.
- Labeler DUNS
- 607903382
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-31
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 8fe55d8b-f8f8-456e-b836-101109238018
Device Description
Walther sound, curved, 1-34" nominal bend height. Features proximal taper to relax the penile meatus. Mirror finish, stainless steel, precision machined.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- ["Liquid Chemical", "Moist Heat or Steam Sterilization"]
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FBX | Sound, Urethral, Metal Or Plastic | Gastroenterology, Urology | 876.5520 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13643 | Urethral sound, reusable | A hand-held manual surgical instrument designed to explore and measure the urethra. It is a slender hollow or solid cylindrical instrument made of metal or plastic typically with graduations of length displayed along its working end. It is typically available in a range of sizes and flexibilities. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10801334012540 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 9.5 | Inch | |
| Catheter Gauge | 28 | French |