FibriJet
MAGELLAN SPRAY TIP, DUAL SPRAY, BULK STERILE, Case of 250, corresponding to individual pouched AMS700 UDI-DI of 00815634021518
110manufacturers in China registered for this device type
35catalogue numbers in this listing
4510(k) clearances naming this product code
2recalls on this code
Who Else Makes It
Concentrated in Jiangsu (31), Guangdong (27), Zhejiang (26). 20 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Gcmedica Enterprise Ltd.(Wuxi) | Wuxi | Jiangsu | Contract manufacturer | 55 |
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| BH Medical Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 37 |
| Suzhou Jinsheng Plastic Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Shun SZE Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 22 |
| Wenzhou Zuoyou Medical Technoloyg Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 21 |
| Jiangsu Caina Medical Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 20 |
| Primecare Medical (Suzhou) Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 20 |
| Suzhou Jingle Polymer Medical Apparatus Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Sunmed AP, Ltd. | Zhuhai | Guangdong | Contract manufacturer | 18 |
| Ningbo Albert Novosino Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 17 |
| Sunmed AP, Ltd., Warehouse NO. 2 | Zhuhai | Guangdong | Contract manufacturer | 16 |
Showing 12 of 110. All 110 manufacturers in China registered for Syringe, Irrigating (Non Dental)
Record
| Listed by | Micromedics, Inc., United States |
|---|---|
| FDA product code | KYZ |
| Device type | Syringe, Irrigating (Non Dental) |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6960 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-06-07 |
| Record revised | 2025-06-23 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Inner pack of 10, inner pack, case of 250, case of 10, inner pack of 5, case of 70 |
| Distribution end date | 2023-02-28 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SA-3674 | In distribution | |
| 800-0202 | In distribution | |
| AMS700-B | In distribution | |
| 800-0225 | In distribution | |
| SA-3646 | In distribution | |
| AMS700 | In distribution | |
| SA-3673 | In distribution | |
| 800-0252 | In distribution | |
| SA-3648 | In distribution | |
| SA-3619 | In distribution | |
| SA-1001 | In distribution | |
| 800-0201 | In distribution | |
| SA-3620 | In distribution | |
| SA-3625 | In distribution | |
| AMS600-B | In distribution | |
| SA-3677 | In distribution | |
| SA-3600 | In distribution | |
| AMS600 | In distribution | |
| SA-1060 | In distribution | |
| SA-3627 | In distribution | |
| SA-3626 | In distribution | |
| SA-3670 | In distribution | |
| AMS604 | In distribution | |
| SA-3305 | In distribution | |
| SA-3647 | In distribution | |
| SA-3303 | In distribution | |
| SA-3610 | In distribution | |
| SA-3671-100 | In distribution | |
| AMS607 | In distribution | |
| SA-3605 | In distribution | |
| SA-3675 | In distribution | |
| SA-3678 | In distribution | |
| 800-0251 | In distribution | |
| SA-3649 | In distribution | |
| AMS700-B | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| LSL Healthcare | Lsl Industries, Inc. | 24 |
| Medline | Medline Industries, Inc. | 21 |
| Baria | Shenzhen Baria Technology Co., Ltd. | 20 |
| Monoject | Cardinal Health 200, LLC | 17 |
| Centurion | Centurion Medical Products Corporation | 17 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 14 |
| Busse Hospital Disposables | Robert Busse & Co., Inc. | 12 |
| Ear and Ulcer Syringe | C.R. Bard, Inc. | 12 |
| Cardinal Health | Cardinal Health 200, LLC | 12 |
| Nordson Medical | Micromedics, Inc. | 10 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 9 |
| Rospital Productos Medicos | Atlas Medical Products LLC | 9 |
Showing 12 of 129. All products under Syringe, Irrigating (Non Dental)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K102563 | 2011-03-15 |
| K940371 | 1994-04-06 |
| K883338 | 1988-08-23 |
| K881020 | 1988-03-25 |
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 |
|---|---|---|---|---|---|
| 2010-03-15 | Not classified | Packaging process control | Micromedics, Inc is conducting a product recall on a number of medical device products because of weak seals of the sterile pouches potentially resulting in a non-sterile product which may cause transmission of disease or infection. | 620 (800 pouches) | 2011-06-21 |
| 2010-03-15 | Not classified | Packaging process control | Micromedics, Inc is conducting a product recall on a number of medical device products because of weak seals of the sterile pouches, potentially resulting in a non-sterile product which may cause transmission of disease or infection. | 4025 (4295 pouches) | 2011-06-21 |
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.