Surgical Direct
11 1/2 Reueable Bowel Sizer, 28 x 33mm, Solid Barrel Shape Style Tip 12.5mm x 24.5cm Hallow Shaft, S
10manufacturers in China registered for this device type
29catalogue numbers in this listing
Who Else Makes It
Concentrated in Hebei (4), Shanghai (3), Guangdong (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Denco Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 52 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
| Shanghai Lions Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 82 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
| Huanghua Promisee Dental Co., Ltd. | Huanghua | Hebei | Manufacturer | 54 |
| Shenzhen Rogin Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 51 |
| Cangzhou Lankang Medical Instruments Developing Co., Ltd. | Cangzhou | Hebei | Manufacturer | 40 |
| Huanghua DK Dental Co., Ltd. | Huanghua | Hebei | Manufacturer | 37 |
Record
| Listed by | Surgical Direct, Inc., United States |
|---|---|
| FDA product code | EIL |
| Device type | Gauge, Depth, Instrument, Dental |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2022-11-23 |
| Record revised | 2024-09-11 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| S35208.42 | In distribution | |
| SD935208030 | In distribution | |
| SD77-0029-28 | In distribution | |
| SD63-133-15 | In distribution | |
| SD935208100 | In distribution | |
| S35208.00 | In distribution | |
| SD935208025 | In distribution | |
| SD93520836 | In distribution | |
| SD93520825 | In distribution | |
| SD935208032 | In distribution | |
| SD63-133-12 | In distribution | |
| SD63-113-14 | In distribution | |
| SD63-133-13 | In distribution | |
| SD935208028 | In distribution | |
| SD93520838 | In distribution | |
| SD935208022 | In distribution | |
| SD93520834 | In distribution | |
| SD15000-10 | In distribution | |
| SD63-133-16 | In distribution | |
| S35208.38 | In distribution | |
| SD63-133-11 | In distribution | |
| SD15000-20 | In distribution | |
| SD93520850 | In distribution | |
| SD93520840 | In distribution | |
| SD77-0029-31 | In distribution | |
| SD93520842 | In distribution | |
| SD93520845 | In distribution | |
| SD77-0029-25 | In distribution | |
| SD15000-00 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Endoring | Jordco, Inc. | 41 |
| Dental Instrument | Cowellmedi Co., Ltd. | 36 |
| Biotem | Biotem Co., Ltd. | 26 |
| HU-Friedy | HU-Friedy MFG Co., LLC | 24 |
| EdgeVerify | US Endodontics, LLC | 24 |
| ACE | Ace Surgical Supply Co., Inc. | 16 |
| devemed | Devemed Gmbh | 13 |
| Genesis | Keystone Dental Inc. | 12 |
| Schwert | A. Schweickhardt Gmbh & Co. KG | 12 |
| Reicodent | Devemed Gmbh | 12 |
| ID-Ring | Diadent Group Intl., Inc. | 11 |
| Thermafil Plus | Tulsa Dental Products LLC | 11 |
Showing 12 of 126. All products under Gauge, Depth, Instrument, 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.