Fibra / Fibra® Sidebite
Catalogue number G-7555, listed by Applied Medical Resources Corp., United States, under Clamp, Vascular. 10 manufacturers in China are registered for this product code.
10manufacturers in China registered for this device type
1catalogue number
2510(k) clearances naming this product code
3recalls on this code
Who Else Makes It
Concentrated in Beijing (3), Zhejiang (2), Guangdong (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Shanghai INT Medical Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Tianjin Demax Medical Technology Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 5 |
| Wickimed (Huizhou) Medical Equipment Manufacturing Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 3 |
| Joykey Industrial (Pinghu) Limited | Pinghu | Zhejiang | Contract manufacturer | 43 |
| Sunny Medical Device (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Lepu Medical Technology (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
| Terumo Medical Products (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 7 |
| Beijing Target Medical Technologies Inc. | Beijing | Beijing | Contract manufacturer | 7 |
| Beijing Demax Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 5 |
Record
| Listed by | Applied Medical Resources Corp., United States |
|---|---|
| FDA product code | DXC |
| Device type | Clamp, Vascular |
| Device class | Class 2 |
| Regulation | 21 CFR 870.4450 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| Record published | 2016-09-24 |
| Record revised | 2022-11-28 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 15 |
| Sizes | Length 75 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G-7555 | Length 75 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Millennium | Avalign Technologies, Inc. | 831 |
| Novo Surgical | Novo Surgical, Inc. | 708 |
| Ambler Surgical | Ambler Surgical, LLC | 575 |
| Pilling | Teleflex Medical LLC | 544 |
| Avalign | Avalign Technologies, Inc. | 543 |
| Boss Instruments | Boss Instruments, Ltd. | 457 |
| V. Mueller | Steris Corporation | 432 |
| Wexler Surgical, Inc. | Wexler Surgical, Inc. | 342 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 331 |
| Scanlan® | Scanlan International, Inc. | 294 |
| HNM Medical | HNM Stainless, LLC. | 230 |
| Aesculap | Aesculap AG | 136 |
Showing 12 of 639. All products under Clamp, Vascular
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K962668 | 1996-11-04 |
| K950492 | 1995-05-08 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2011-03-07 | Not classified | Other | The recall was initiated because Applied Medical has confirmed that Surgical Clamp Inserts, Model Numbers: G-8600, G-8650, G-8655, has the potential packaging nonconformance which could result in a compromise to the sterile barrier. | 20,247 units total | 2012-03-26 |
| 2011-03-07 | Not classified | Other | The recall was initiated because Applied Medical has confirmed that Surgical Clamp Inserts, Model Numbers: G-8600, G-8650, G-8655, has the potential packaging nonconformance which could result in a compromise to the sterile barrier. | 20,247 units total | 2012-03-26 |
| 2011-03-07 | Not classified | Other | The recall was initiated because Applied Medical has confirmed that Surgical Clamp Inserts, Model Numbers: G-8600, G-8650, G-8655, has the potential packaging nonconformance which could result in a compromise to the sterile barrier. | 20,247 units total | 2012-03-26 |
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.