Trinity Sterile, Inc.
Sims Uterine Sound 12 1/2| PLN
1manufacturer
1catalogue number
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 | Trinity Sterile, Inc., United States |
|---|---|
| FDA product code | FBX |
| Device type | Sound, Urethral, Metal Or Plastic |
| Device class | Class 1 |
| Regulation | 21 CFR 876.5520 |
| Establishment | Contract manufacturer, Contract steriliser, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-10-23 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number, serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| T98-384 | 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 |
| Hayden Medical | Hayden Medical Inc | 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 |
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.