Integra® Jarit®
Integra® Jarit® Gruber Ear Specula Set of 4, Short Oval, without Case, (REF #'s X2025, X2027, X2029, X2031)
9manufacturers in China registered for this device type
104catalogue 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 | 2018-04-03 |
| Record revised | 2023-04-19 (version 8) |
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 |
| Storage | Special storage condition: No |
| Sizes | Outer diameter 25 mm; length 33 mm; depth 28.5 to 32.5 mm |
| Distribution end date | 2023-12-04 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 375163 | 4.5mm | In distribution |
| 375112 | In distribution | |
| X2051 | In distribution | |
| 375203 | In distribution | |
| P4272 | In distribution | |
| 400112 | In distribution | |
| 375207 | In distribution | |
| 375020 | 1-3/4″ | In distribution |
| X318 | In distribution | |
| 400145 | In distribution | |
| 375042 | 1-3/4″ | In distribution |
| 375024 | 4.5mm x 5.5mm | In distribution |
| P4270 | In distribution | |
| 400140 | In distribution | |
| X314761 | In distribution | |
| 375111 | In distribution | |
| 375141 | In distribution | |
| 375142 | In distribution | |
| 375034 | 1-3/4″ | In distribution |
| 400117 | In distribution | |
| 375204 | In distribution | |
| 375143 | In distribution | |
| 400102 | In distribution | |
| X314746 | In distribution | |
| X314786 | In distribution | |
| P4263 | 5-3/8″ | In distribution |
| 400143 | In distribution | |
| 375048 | 1-3/4″ | In distribution |
| 375103 | In distribution | |
| X2031 | In distribution | |
| 375150 | Outer Diameter 25 mm | In distribution |
| X314856 | In distribution | |
| 375152 | 4mm inner diameter | In distribution |
| 375132 | 4mm inner diameter | In distribution |
| 375050 | 1-3/4″ | In distribution |
| 375162 | 3.5mm | In distribution |
| 400121 | In distribution | |
| P4275 | In distribution | |
| 375113 | In distribution | |
| 400101 | In distribution | |
| 375110 | In distribution | |
| 375100 | In distribution | |
| 375054 | 7mm x 8mm | In distribution |
| 400116 | In distribution | |
| X2029 | In distribution | |
| 400122 | In distribution | |
| 375144 | In distribution | |
| 375104 | In distribution | |
| 375032 | 6.5mm x 7.5mm | In distribution |
| 375161 | 3.5mm | In distribution |
| 375160 | In distribution | |
| 375056 | 7.5mm x 8.5mm | In distribution |
| P4262 | Depth 28.5 mm | In distribution |
| X317 | In distribution | |
| 375140 | In distribution | |
| 375101 | In distribution | |
| 375151 | 3mm inner diameter | In distribution |
| P4264 | In distribution | |
| 400141 | In distribution | |
| 400115 | In distribution | |
| 375036 | 7.5mm x 8.5mm | In distribution |
| 375044 | 4.5mm x 5.5mm | In distribution |
| X314701 | In distribution | |
| P4261 | Depth 29 mm | In distribution |
| P4271 | In distribution | |
| X314886 | In distribution | |
| 400105 | In distribution | |
| 375209 | In distribution | |
| 375208 | In distribution | |
| 400136 | In distribution | |
| 400120 | In distribution | |
| 375102 | 3.5 mm | In distribution |
| X2027 | In distribution | |
| 375154 | Length 33 mm | In distribution |
| 375201 | In distribution | |
| 400110 | In distribution | |
| 375026 | 5mm x 6mm | In distribution |
| 400100 | In distribution | |
| 375164 | 6.5mm | In distribution |
| 400146 | In distribution | |
| 400144 | In distribution | |
| 375022 | 1-3/4″ | In distribution |
| 375153 | Outer Diameter 25 mm | In distribution |
| 375133 | Outer Diameter 25 mm | In distribution |
| 375028 | 5.5mm x 6.5mm | In distribution |
| 375114 | In distribution | |
| 375130 | Outer Diameter 25 mm | In distribution |
| X2071 | In distribution | |
| 375202 | In distribution | |
| 375040 | 1-3/4″ | In distribution |
| 375206 | In distribution | |
| 375134 | Length 33 mm | In distribution |
| X2023 | In distribution | |
| 375046 | 5mm x 6mm | In distribution |
| 375052 | 1-3/4″ | In distribution |
| X2059B | In distribution | |
| 375030 | 1-3/4″ | In distribution |
| 400142 | In distribution | |
| X2025 | In distribution | |
| 375131 | Outer Diameter 25 mm | In distribution |
| 375205 | In distribution | |
| X2021 | Withdrawn | |
| P4270FO | Withdrawn | |
| X203 | 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.