Custom Healthcare Systems Inc.
Catalogue number B9-11260, listed by Manus Medical, LLC, United States, under Tray, Surgical, Ent. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Shandong (1), Hubei (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Hubei Lanbin Medical Group Co., Ltd. | Xiaogan | Hubei | Contract manufacturer | 33 |
| PRO-MED (Wuxi)IMP.& Exp.co., Ltd. | Wuxi | Jiangsu | Exporter | 24 |
Record
| Listed by | Manus Medical, LLC, United States |
|---|---|
| FDA product code | MMO |
| Device type | Tray, Surgical, Ent |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Contract manufacturer, Contract steriliser, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-07-29 |
| Record revised | 2023-06-08 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | N/a of 20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| B9-11260 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline Industries, Inc. | Medline Industries, Inc. | 63 |
| Integra® | Integra LifeSciences Production Corporation | 16 |
| MicroFrance® | Integra Microfrance SAS | 15 |
| Endoscope container with lid | Spiggle & Theis Medizintechnik Gmbh | 9 |
| Ace Medical Company | Ebner Medical LLC | 7 |
| Integra® | Integra Microfrance SAS | 6 |
| Medical Action Industries | Medical Action Industries, Inc. | 5 |
| Endoscope container with lid, stainless | Spiggle & Theis Medizintechnik Gmbh | 4 |
| ACE Medical | Ebner Medical LLC | 3 |
| Endoscope sterilizing & protecting tray | Spiggle & Theis Medizintechnik Gmbh | 3 |
| Instrument box with cover | Spiggle & Theis Medizintechnik Gmbh | 3 |
| Fentex | Fentex medical GmbH | 2 |
Showing 12 of 62. All products under Tray, Surgical, Ent
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.