Integra®
Integra® Table Straight Bracket Blade
3manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (1), Zhejiang (1), Guangdong (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 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Nanhai YI XIN Plastic Tableware Manufacturing Co Ltd | Foshan | Guangdong | Manufacturer | 3 |
Record
| Listed by | Integra LifeSciences Production Corporation, United States |
|---|---|
| FDA product code | FXG |
| Device type | Specula Accessories |
| Device class | Class 1 |
| Regulation | 21 CFR 878.1800 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-09-17 |
| Record revised | 2023-04-18 (version 3) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1362275 | In distribution | |
| 1352282 | In distribution | |
| 1352277 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| BR Surgical, LLC | BR Surgical LLC | 3 |
| Neotech Ocular Exam Kit | Neotech Products, LLC | 2 |
| Ambler Surgical | Ambler Surgical, LLC | 1 |
| Ocular Exam Depressor | Neotech Products, LLC | 1 |
| Ear funnel, grey, small, Ø 2,5 mm, PU = 1000 pcs. | Kirchner & Wilhelm GmbH + Co.KG | 1 |
| Ocular Exam Standard Speculum | Neotech Products, LLC | 1 |
| Realstar Surgical Instruments | Real Star Surgical Instruments | 1 |
| Ear funnel, grey, small Ø 2.5 mm, 10 x 100 pcs. in polybag | Kirchner & Wilhelm GmbH + Co.KG | 1 |
| Ear funnel, grey, large Ø 4.0 mm, 10×100 pcs. in polybag | Kirchner & Wilhelm GmbH + Co.KG | 1 |
| Ear funnel, black, large Ø 4.0 mm, in units of 100 pcs. | Kirchner & Wilhelm GmbH + Co.KG | 1 |
| Pilling | Teleflex Medical LLC | 1 |
| Neonatal Ocular Exam Kit 2-pack | Neotech Products, LLC | 1 |
Showing 12 of 25. All products under Specula Accessories
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Integra Lifesciences Corporation | UDI-DI | 2022-02-28 | Class II | Device Design | Excess force used to tighten the Universal Flexible Arm can cause the internal cable to break at the tip, resulting in an unusable condition. | 54 |
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.