Integra®
Integra® Farrior Speculum, 1-3/4", Oval Oblique Ends, 10.0mm x 12.0mm, 1-3/4", Size 6
9manufacturers in China registered for this device type
93catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (4), Jiangsu (3), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Zhejiang Gongdong Medical Technology Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 40 |
| Zumax Medical Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Little Doctor Electronic(Nantong) Co., Ltd. | Nantong | Jiangsu | Contract manufacturer | 17 |
| Taizhou Honod Medical Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 7 |
| Yuyao Guangjing Medical Instrument Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 7 |
Record
| Listed by | Integra LifeSciences Production Corporation, United States |
|---|---|
| FDA product code | EPY |
| Device type | Speculum, Ent |
| Device class | Class 1 |
| Regulation | 21 CFR 878.1800 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-10-24 |
| Record revised | 2025-04-07 (version 4) |
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, manufacturing date |
| Sizes | Length 33.5 to 38 mm; outer diameter 16 to 18.5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3724128 | 11.0mm x 13.0mm | In distribution |
| 3724403 | 4mm x 5mm | In distribution |
| 3724141 | In distribution | |
| 3724106 | In distribution | |
| 3724112 | In distribution | |
| 3724095 | In distribution | |
| 3724163 | 5 | In distribution |
| 3714688 | In distribution | |
| 3724144 | In distribution | |
| 3724146 | In distribution | |
| 3714480 | In distribution | |
| 3714472 | In distribution | |
| 3724402 | 3.5mm x 4.5mm | In distribution |
| 3724109 | In distribution | |
| 3724111 | In distribution | |
| 3724407 | 6mm x 7mm | In distribution |
| 3724122 | 5.0mm x 6.0mm | In distribution |
| 3724145 | In distribution | |
| 3714210 | In distribution | |
| 3714201 | In distribution | |
| 3724153 | In distribution | |
| 3714479 | In distribution | |
| 3724110 | In distribution | |
| 3714476 | In distribution | |
| 3724104 | In distribution | |
| 3724124 | 1-3/4″ | In distribution |
| 3714211 | In distribution | |
| 3724127 | 10.0mm x 12.0mm | In distribution |
| 3724162 | 4 | In distribution |
| 3724155 | In distribution | |
| 3724101 | In distribution | |
| 3714208 | In distribution | |
| 3714477 | In distribution | |
| 3724147 | In distribution | |
| 3714690 | In distribution | |
| 3724142 | In distribution | |
| 3724108 | In distribution | |
| 3714203 | In distribution | |
| 3714212 | In distribution | |
| 3714213 | In distribution | |
| 3724159 | Length 33.5 mm | In distribution |
| 3714207 | In distribution | |
| 3724093 | In distribution | |
| 3724125 | 8.0mm x 10.0mm | In distribution |
| 3724410 | 7.5mm x 8.5mm | In distribution |
| 3724160 | Outer Diameter 17.5 mm | In distribution |
| 3714475 | In distribution | |
| 3724107 | In distribution | |
| 3724406 | 1-3/4″ | In distribution |
| 3714206 | In distribution | |
| 3724113 | In distribution | |
| 3724097 | In distribution | |
| 3724103 | In distribution | |
| 3724405 | 1-3/4″ | In distribution |
| 3724102 | In distribution | |
| 3714483 | In distribution | |
| 3724100 | In distribution | |
| 3714199 | In distribution | |
| 3724138 | In distribution | |
| 3724099 | In distribution | |
| 3724404 | 1-3/4″ | In distribution |
| 3724411 | 1-3/4″ | In distribution |
| 3724096 | In distribution | |
| 3724151 | In distribution | |
| 3724408 | 6.5mm x 7.5mm | In distribution |
| 3724161 | 3 | In distribution |
| 3724126 | 1-3/4″ | In distribution |
| 3714691 | In distribution | |
| 3714209 | In distribution | |
| 3724150 | In distribution | |
| 3714205 | In distribution | |
| 3724094 | In distribution | |
| 3714204 | In distribution | |
| 3724114 | In distribution | |
| 3714471 | In distribution | |
| 3724409 | 7mm x 8mm | In distribution |
| 3724148 | In distribution | |
| 3724105 | In distribution | |
| 3714478 | In distribution | |
| 3714215 | In distribution | |
| 3724123 | 6.0mm x 7.0mm | In distribution |
| 3724143 | In distribution | |
| 3714481 | In distribution | |
| 3714214 | In distribution | |
| 3724098 | In distribution | |
| 3724401 | 3mm x 4mm | In distribution |
| 3724157 | In distribution | |
| 3714692 | In distribution | |
| 3724154 | In distribution | |
| 3714687 | In distribution | |
| 3714482 | In distribution | |
| 3714200 | In distribution | |
| 3714202 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 203 |
| Ambler Surgical | Ambler Surgical, LLC | 190 |
| Sklar® | Sklar Corporation | 180 |
| Aesculap | Aesculap AG | 170 |
| Boss Instruments | Boss Instruments, Ltd. | 161 |
| Fentex | Fentex medical GmbH | 157 |
| Millennium | Avalign Technologies, Inc. | 148 |
| Bear | Bear-ENT, LLC | 145 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 142 |
| BR Surgical, LLC | BR Surgical LLC | 133 |
| Surtex | Surtex Instruments Ltd | 110 |
| Jedmed | Jedmed Instrument Company | 106 |
Showing 12 of 260. All products under Speculum, Ent
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.