Hayden Medical
Walther Urethral Sounds 11" (27.9cm), (Set of 11), tapered shaft downward towards handle, 16Fr. (5.3mm) thru 36Fr. (11.9mm)
1manufacturer
105catalogue numbers in this listing
Who Else Makes It
Registered in Shandong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
Record
| Listed by | Hayden Medical Inc, United States |
|---|---|
| FDA product code | FBX |
| Device type | Sound, Urethral, Metal Or Plastic |
| Device class | Class 1 |
| Regulation | 21 CFR 876.5520 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2022-08-08 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 285-409 | In distribution | |
| 285-212 | In distribution | |
| 285-114 | In distribution | |
| 285-322 | In distribution | |
| 285-826 | In distribution | |
| 285-608 | In distribution | |
| 285-613 | In distribution | |
| 285-412 | In distribution | |
| 285-310 | In distribution | |
| 285-338 | In distribution | |
| 285-818 | In distribution | |
| 285-400 | In distribution | |
| 285-112 | In distribution | |
| 285-209 | In distribution | |
| 285-108 | In distribution | |
| 285-202 | In distribution | |
| 285-500 | In distribution | |
| 285-820 | In distribution | |
| 285-411 | In distribution | |
| 285-316 | In distribution | |
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| 285-113 | In distribution | |
| 285-830 | In distribution | |
| 285-606 | In distribution | |
| 285-098 | In distribution | |
| 285-201 | In distribution | |
| 285-115 | In distribution | |
| 285-528 | In distribution | |
| 285-336 | In distribution | |
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| 285-111 | In distribution | |
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| 285-401 | In distribution | |
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| 285-518 | In distribution | |
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| 285-408 | In distribution | |
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| 285-324 | In distribution | |
| 285-211 | In distribution | |
| 285-332 | In distribution | |
| 285-516 | In distribution | |
| 285-834 | In distribution | |
| 285-822 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sklar® | Sklar Corporation | 204 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 165 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 105 |
| Greenwald Surgical Company, Inc. | Grace Manufacturing Inc | 95 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 87 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 82 |
| V. Mueller | Steris Corporation | 73 |
| BR Surgical, LLC | BR Surgical LLC | 70 |
| Aesculap | Aesculap AG | 63 |
| HNM Medical | HNM Stainless, LLC. | 54 |
| Novo Surgical | Novo Surgical, Inc. | 45 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 21 |
Showing 12 of 33. All products under Sound, Urethral, Metal Or Plastic
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.