Stoma®
Sharp spoon, Hemingway modified,4,5mm, 17,5cm, DE
3manufacturers in China registered for this device type
27catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
Record
| Listed by | Storz AM Mark Gmbh, Germany |
|---|---|
| FDA product code | EKE |
| Device type | Curette, Operative |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-08-27 |
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 |
|---|---|---|
| 4621.15 | In distribution | |
| 4623.30 | In distribution | |
| 4620.25 | In distribution | |
| 4620.15 | In distribution | |
| 4621.30 | In distribution | |
| 14619.35 | In distribution | |
| 4640.01 | In distribution | |
| 4623.65 | In distribution | |
| 14615.00 | In distribution | |
| 4623.40 | In distribution | |
| 4631.35 | In distribution | |
| 14620.10 | In distribution | |
| 4620.30 | In distribution | |
| 4636.30 | In distribution | |
| 4636.45 | In distribution | |
| 4636.25 | In distribution | |
| 4631.25 | In distribution | |
| 14619.34 | In distribution | |
| 4640.00 | In distribution | |
| 4621.25 | In distribution | |
| 4630.25 | In distribution | |
| 4636.35 | In distribution | |
| 4624.25 | In distribution | |
| 14620.00 | In distribution | |
| 4630.30 | In distribution | |
| 4631.30 | In distribution | |
| 4630.35 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Kohdent | Kohler Medizintechnik GmbH | 30 |
| J & J Instruments | J & J Instruments, LLC | 12 |
| Henry Schein | Henry Schein, Inc. | 8 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 6 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 3 |
| Benco | Benco Dental Supply Co. | 3 |
| Curette Molt 2/4HD Angled HD D/E Serr | W.H. Holden, Inc. | 2 |
| Curette Molt 2/4HD Angled HF D/E | W.H. Holden, Inc. | 2 |
| Curette Bone Miller #12 CH D/E Serr | W.H. Holden, Inc. | 2 |
| Curette Molt 2/4HD Angled HD D/E | W.H. Holden, Inc. | 2 |
| Curette Molt 2/4HD Angled CH Handle D/E | W.H. Holden, Inc. | 2 |
| Sinus Curette Feuer 2 HF D/E | W.H. Holden, Inc. | 2 |
Showing 12 of 206. All products under Curette, Operative
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.