Integra® Miltex®
Integra® Miltex® Gruber Ear Specula Set of 4, Short Oval, with Case, Includes:(REF #'s 19-14, 19-16, 19-18, & 19-20)
9manufacturers in China registered for this device type
75catalogue 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 | 2020-10-01 |
| Record revised | 2024-03-06 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
| Sizes | Outer diameter 3 to 25 mm; length 33 mm; length 6 in; angle 90 ° |
| Distribution end date | 2022-05-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PM-4275 | In distribution | |
| 19-48 | Outer Diameter 25 mm | In distribution |
| 20-2 | 5-3/8″ | In distribution |
| 19-50-7 | 6.5mm x 7.5mm | In distribution |
| 19-20 | In distribution | |
| 19-32 | 1-1/4″ | In distribution |
| PM-4264 | 32mm Blades | In distribution |
| 20-36-50 | In distribution | |
| PM-4671 | 73mm Blades | In distribution |
| 19-50-9 | 1-3/4″ | In distribution |
| MH20-29 | In distribution | |
| 19-71-2 | In distribution | |
| 19-50-1 | 1-3/4″ | In distribution |
| 19-60 | In distribution | |
| 19-10 | In distribution | |
| 20-24 | 5-1/2″ | In distribution |
| 20-7 | In distribution | |
| 20-29 | 2-1/2″ Blades | In distribution |
| 20-30 | 3″ Blades | In distribution |
| 19-18 | In distribution | |
| 19-50-5 | 1-3/4″ | In distribution |
| 19-2-3 | In distribution | |
| PM-4270FO | In distribution | |
| MH20-32 | In distribution | |
| 19-14 | In distribution | |
| 20-37-45 | In distribution | |
| V920-3 | In distribution | |
| 20-32 | Length 6 in | In distribution |
| MH20-3 | In distribution | |
| 19-24 | In distribution | |
| 19-50-3 | 4.5mm x 5.5mm | In distribution |
| 19-48-E | Outer Diameter 25 mm | In distribution |
| 19-30 | In distribution | |
| 20-36-75 | In distribution | |
| 19-22 | In distribution | |
| 20-12 | 5-1/4″ | In distribution |
| 19-48-C | 4mm inner diameter | In distribution |
| 19-36 | Outer Diameter 5 mm | In distribution |
| 19-16 | In distribution | |
| V920-2 | In distribution | |
| 19-2 | In distribution | |
| 206 | In distribution | |
| 19-25 | In distribution | |
| MH20-4 | 5-3/8″ | In distribution |
| 20-3 | 5-3/8″ | In distribution |
| 19-34 | 1-3/8″ | In distribution |
| MH20-2 | In distribution | |
| 19-48-D | Outer Diameter 25 mm | In distribution |
| 19-50-8 | 7mm x 8mm | In distribution |
| 19-21 | In distribution | |
| 20-20 | In distribution | |
| MH20-30 | In distribution | |
| 19-12 | In distribution | |
| 19-48-A | Length 33 mm | In distribution |
| V920-4 | In distribution | |
| 19-2-4 | In distribution | |
| 19-2-2 | In distribution | |
| 20-36-90 | In distribution | |
| 20-28 | 2″ Blades | In distribution |
| 203635 | In distribution | |
| MH20-28 | In distribution | |
| 19-50-4 | 5mm x 6mm | In distribution |
| MH20-12 | In distribution | |
| 19-71-3 | In distribution | |
| 20-4 | Angle 90 ° | In distribution |
| 19-2-1 | In distribution | |
| 19-50-6 | 6mm x 7mm | In distribution |
| 19-50-2 | 4mm x 5mm | In distribution |
| MH20-24 | In distribution | |
| 19-23 | In distribution | |
| 19-40 | Length 33 mm | In distribution |
| 20-37-75 | In distribution | |
| 19-48-B | 3mm inner diameter | In distribution |
| 19-71 | Withdrawn | |
| 19-71-1 | Withdrawn |
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.