Integra®
Integra® House Suction Irrigator , 3-1/2" Working Length, 2 Fr and 2.5 Fr., With Thumb Plate
5manufacturers in China registered for this device type
77catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (3), Shanghai (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Ningbo Chibanda IMP &EXP Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 59 |
| Ningbo Favored Commodity Co., Ltd. | Ningbo | Zhejiang | Specification developer | 21 |
| Anji Hengfeng Sanitary Material Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 20 |
| DU-Hope International Group | Nanjing | Jiangsu | Contract manufacturer | 11 |
Record
| Listed by | Integra LifeSciences Production Corporation, United States |
|---|---|
| FDA product code | JZF |
| Device type | Tube, Ear Suction |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-10-24 |
| Record revised | 2025-08-26 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Do Not Use if Package is Damaged |
| Sizes | Catheter gauge 3 to 24 Fr; length 3 to 4 in; outer diameter 0.8 to 4.7 mm; angle 90 to 120 ° |
| Distribution end date | 2022-05-01 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 3724214 | 3-7/8″ | In distribution | |
| 3724190 | 18 Gauge | In distribution | |
| 3724199 | 14 Gauge | In distribution | |
| 3714003 | Catheter Gauge 9 Fr | In distribution | |
| 3724187 | In distribution | ||
| 3714257 | Catheter Gauge 12 Fr | In distribution | |
| 3724181 | Catheter Gauge 5 Fr | In distribution | |
| 3714050 | In distribution | ||
| 3714004 | Outer Diameter 3.3 mm | In distribution | |
| 3724218 | In distribution | ||
| 3724225 | In distribution | ||
| 3724217 | In distribution | ||
| 3724173 | Catheter Gauge 5 Fr | In distribution | |
| 3714254 | Length 4 in | In distribution | |
| 3714250 | Length 4 in | In distribution | |
| 3714262 | Catheter Gauge 9 Fr | In distribution | |
| 3714007 | Catheter Gauge 14 Fr | In distribution | |
| 3724421 | In distribution | ||
| 3724175 | Catheter Gauge 7 Fr | In distribution | |
| 3724422 | In distribution | ||
| 3724221 | In distribution | ||
| 3714263 | Catheter Gauge 10 Fr | In distribution | |
| 3714265 | 5-7/8″ | In distribution | |
| 3724194 | 1-1/2″ | In distribution | |
| 3724220 | In distribution | ||
| 3724216 | In distribution | ||
| 3714000 | Catheter Gauge 6 Fr | In distribution | |
| 3714049 | In distribution | ||
| 3724177 | Length 4 in | In distribution | |
| 3714255 | Length 4 in | In distribution | |
| 3724206 | 22 Gauge | In distribution | |
| 3734110 | 10-3/4″ | In distribution | |
| 3724210 | Catheter Gauge 22 Fr | In distribution | |
| 3724211 | 2-7/8″ | In distribution | |
| 3714261 | Catheter Gauge 8 Fr | In distribution | |
| 3724196 | 2-3/4″ | In distribution | |
| 3724189 | 2-3/4″ | In distribution | |
| 3724205 | 20 Gauge | In distribution | |
| 3724179 | Length 4 in | In distribution | |
| 3714006 | Length 4 in | In distribution | |
| 3724215 | 3-7/8″ | In distribution | |
| 3714260 | Catheter Gauge 7 Fr | In distribution | |
| 3724224 | In distribution | ||
| 3714259 | 5-7/8″ | In distribution | |
| 3724420 | In distribution | ||
| 3724184 | In distribution | ||
| 3724182 | Catheter Gauge 7 Fr | In distribution | |
| 3734111 | 10-3/4″ | In distribution | |
| 3724186 | In distribution | ||
| 3724226 | In distribution | ||
| 3724188 | In distribution | ||
| 3714253 | Length 4 in | In distribution | |
| 3714001 | Outer Diameter 2.3 mm | In distribution | |
| 3724213 | 3-7/8″ | In distribution | |
| 3724172 | Catheter Gauge 3 Fr | In distribution | |
| 3734109 | Catheter Gauge 6 Fr | In distribution | |
| 3714252 | Length 4 in | In distribution | |
| 3724201 | 16 Gauge | In distribution | |
| 3724200 | 15 Gauge | In distribution | |
| 3724219 | In distribution | ||
| 3724222 | In distribution | ||
| 3724207 | 24 Gauge | In distribution | |
| 3714251 | Length 4 in | In distribution | |
| 3724203 | 18 Gauge | In distribution | |
| 3724223 | In distribution | ||
| 3724209 | 2-7/8″ | In distribution | |
| 3714002 | Length 4 in | In distribution | |
| 3724191 | 20 Gauge | In distribution | |
| 3714005 | Catheter Gauge 11 Fr | In distribution | |
| 3724193 | 1-1/2″ | In distribution | |
| 3724185 | In distribution | ||
| 3714264 | Angle 120 ° | In distribution | |
| 3724183 | In distribution | ||
| 3714000S | 6-1/2″ | In distribution | |
| 3724178 | Catheter Gauge 5 Fr | In distribution | |
| 3714258 | Length 4 in | In distribution | |
| 1358270 | 10 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Network | Network Medical Products, Ltd. | 143 |
| MicroFrance® | Integra Microfrance SAS | 137 |
| HNM Medical | HNM Stainless, LLC. | 120 |
| Ambler Surgical | Ambler Surgical, LLC | 101 |
| Bausch + Lomb | Bausch & Lomb Incorporated | 95 |
| Exmoor | Exmoor Plastics Limited | 92 |
| V. Mueller | Steris Corporation | 86 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 78 |
| Bear | Bear-ENT, LLC | 64 |
| Suction Tube | Koros U.S.A., Inc. | 64 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 60 |
| Millennium | Avalign Technologies, Inc. | 50 |
Showing 12 of 232. All products under Tube, Ear Suction
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.