Ambler Surgical
Pratt fistula probe, 8 1/4'', narrow crypt hook, hexagonal handle
1manufacturer
3catalogue numbers in this listing
Who Else Makes It
Registered in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
Record
| Listed by | Ambler Surgical, LLC, United States |
|---|---|
| FDA product code | HDE |
| Device type | Hook, Fibroid, Gynecological |
| Device class | Class 1 |
| Regulation | 21 CFR 884.4520 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2021-01-07 |
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 |
|---|---|---|
| Buie fistula probe | In distribution | |
| Pratt fistula probe | In distribution | |
| Pratt fistula probe | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Elmed Incorporated | Elmed, Inc. | 9 |
| V. Mueller | Steris Corporation | 8 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 4 |
| Millennium | Avalign Technologies, Inc. | 4 |
| Ambler Value Line | Ambler Surgical, LLC | 3 |
| Pilling | Teleflex Medical LLC | 3 |
| Hayden Medical | Hayden Medical Inc | 2 |
| Novo Surgical | Novo Surgical, Inc. | 2 |
| Avalign | Avalign Technologies, Inc. | 2 |
| Symmetry Buie | Aspen Surgical Products, Inc. | 1 |
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.