Surgical Direct
9 1/2" Coakley Sinus Curette, Double-Ended, 7.7mm Slightly Angled Triangular Tip & 9.7mm 90 Degree Angled Oval Tip
4manufacturers in China registered for this device type
693catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Shandong (1), Guangxi (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 |
| Guilin Yikeshi Medical Device Co Ltd | Guilin | Guangxi | Manufacturer | 28 |
| Hangzhou Haizhu MIM Products Co., Ltd. | Hangzhou | Zhejiang | Exporter | 28 |
Record
| Listed by | Surgical Direct, Inc., United States |
|---|---|
| FDA product code | EMK |
| Device type | Curette, Surgical, Dental |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2024-10-23 |
| Record revised | 2025-08-12 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number |
| Distribution end date | 2024-06-14 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SD914641101 | In distribution | |
| SD914634210 | In distribution | |
| SD9155301006 | In distribution | |
| SD915530090 | In distribution | |
| SD91460303 | In distribution | |
| SD91462805 | In distribution | |
| SD914709208 | In distribution | |
| SD91463159 | In distribution | |
| SD61-0349 | In distribution | |
| SD914653111 | In distribution | |
| SD914613108 | In distribution | |
| SD91464001 | In distribution | |
| SD915532205 | In distribution | |
| S34086.600 | In distribution | |
| SD4105 | In distribution | |
| S34444.100 | In distribution | |
| SD91462502 | In distribution | |
| SD921441100 | In distribution | |
| SD9146120 | In distribution | |
| SD914657270 | In distribution | |
| SD144652-04 | In distribution | |
| SD914634101 | In distribution | |
| SD91462315 | In distribution | |
| SD914637004 | In distribution | |
| SD914653123 | In distribution | |
| SD914637111 | In distribution | |
| SD915570060 | In distribution | |
| SD920686101 | In distribution | |
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| SD934451100 | In distribution | |
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| SD91463300 | In distribution | |
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| SD914653101 | In distribution | |
| SD91461100 | In distribution | |
| SD915591100 | In distribution | |
| SD49107 | In distribution | |
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| SD14630-1004 | In distribution | |
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| SD144652-02 | In distribution | |
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| SD14663-2000 | In distribution | |
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| SD144652-1001 | In distribution | |
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| SD914653104 | In distribution | |
| SD14663-2001 | In distribution | |
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| SD921704100 | In distribution | |
| SD14630-1003 | In distribution | |
| SD91463105 | In distribution | |
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| SD92171005 | In distribution | |
| SD14631-1001 | In distribution | |
| SD914637117 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| A. Titan Instruments | A. Titan Instruments, Inc. | 170 |
| HU-Friedy | HU-Friedy MFG Co., LLC | 112 |
| Nordent Manufacturing Inc | Nordent Manufacturing Inc | 85 |
| Schwert | A. Schweickhardt Gmbh & Co. KG | 72 |
| Paul Banditt | Terlain Enterprises, Inc. | 52 |
| Helmut Zepf | Helmut Zepf Medizintechnik Gmbh | 45 |
| Sklar® | Sklar Corporation | 40 |
| Anatomic Colours | Aesculap AG | 39 |
| Zoll-Dental | Zoll-Dental | 39 |
| Aesculap | Aesculap AG | 39 |
| devemed | Devemed Gmbh | 33 |
| Reicodent | Devemed Gmbh | 30 |
Showing 12 of 107. All products under Curette, Surgical, Dental
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.