Medline
BAG, Banded, W/ Rubberband, Sterile, 36X
15manufacturers in China registered for this device type
27catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (6), Shanghai (3), Anhui (3). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Principle & Will Biotech (Pinghu) Co., Ltd. | Pinghu | Zhejiang | Contract manufacturer | 39 |
| Dongguan Hong De Medical Plastic Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 32 |
| Suzhou Pac-Dent Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 26 |
| Sino Protection (Hefei) Medical Products Co., Ltd. | Hefei | Anhui | Contract manufacturer | 18 |
| Changzhou DSB Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 16 |
| Heyuan Hong DE Medical Products Co., Ltd. | Heyuan | Guangdong | Contract manufacturer | 13 |
| Dongguan SafeSecure Plastics Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 6 |
| S.E.S. Healthcare Products Co., Ltd. | Heifei | Anhui | Contract manufacturer | 5 |
| Shanghai Leyi Plastic Products Co Ltd | Shanghai | Shanghai | Contract manufacturer | 5 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Dongguan Shin YI Healthcare Products Factory | Dong Guan | Guangdong | Contract manufacturer | 30 |
| Shanghai Huayue Packaging Products Co., Ltd. | Fengxian District | Shanghai | Contract manufacturer | 18 |
Showing 12 of 15. All 15 manufacturers in China registered for Cover, Barrier, Protective
Record
| Listed by | Medline Industries, Inc., United States |
|---|---|
| FDA product code | MMP |
| Device type | Cover, Barrier, Protective |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4370 |
| Premarket notification | Exempt |
| Record published | 2016-10-14 |
| Record revised | 2024-09-11 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: away from sunlight. Fragile handle with care. |
| Packaging | Pack of 100, case of 25, case of 40, pack of 60, pack of 80, case of 20 |
| Sizes | Length 90 in; width 60 in |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 31362CS | In distribution | ||
| 61025CS | In distribution | ||
| DYNJEX60050S | In distribution | ||
| DYNJE4400 | In distribution | ||
| DYNJE60026S | In distribution | ||
| DYNJE60040S | In distribution | ||
| DYNJEX63636R | In distribution | ||
| 61024CS | In distribution | ||
| DYNJP2320 | Length 90 in | In distribution | |
| DYNJE4400XLR | In distribution | ||
| 36816ACS | In distribution | ||
| 61026CS | In distribution | ||
| DYNJE60020S | In distribution | ||
| 31405CS | 80 | In distribution | |
| DYNJEX4500 | In distribution | ||
| DYNJE60050S | In distribution | ||
| DYNJEX4250 | In distribution | ||
| 31369CS | In distribution | ||
| 31359CS | In distribution | ||
| MC10NSK | In distribution | ||
| 11348CS | In distribution | ||
| DYNJEX60040S | In distribution | ||
| 31374CS | In distribution | ||
| DYNJE4430 | In distribution | ||
| DYNJE5500 | In distribution | ||
| DYNJE4200 | In distribution | ||
| 37466CS | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DeRoyal | Deroyal Industries, Inc. | 63 |
| Medline Industries, Inc. | Medline Industries, Inc. | 24 |
| Patterson® | Patterson Dental Supply, Inc. | 11 |
| Curaplex | Bound Tree Medical, LLC | 9 |
| Equipment Cover Bag Type | Argon Medical Devices, Inc. | 8 |
| Cover, Barrier, Protective | Mavig Gmbh | 7 |
| Pinnacle X-Ray Sensor Sheaths | Metrex Research | 7 |
| Mizuho OSI | Maytex Corp. | 6 |
| Spectrum, Inc. | Spectrum Medical Ltd | 5 |
| Quala | National Distribution & Contracting Inc | 5 |
| Equipment Cover | Argon Medical Devices, Inc. | 5 |
| Equipment Cover Dome Type | Argon Medical Devices, Inc. | 5 |
Showing 12 of 97. All products under Cover, Barrier, Protective
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K032065 | 2003-09-22 |
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.