Instrusafe
8 catalogue numbers from IN-7900-NF, listed by Summit Medical LLC, United States, under Dropper, Ent. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
8catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (3), Zhejiang (1), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo Albert Novosino Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 17 |
| Lianyungang Brilliant Industrial Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 10 |
| Guangzhou Baoli Hardware & Electronic Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 20 |
| Dongguan City Yuankang Silicon Metal Products Co., Ltd. | Dongguan | Guangdong | Manufacturer | 7 |
| SHENZhEN Kean Silicone Product Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
Record
| Listed by | Summit Medical LLC, United States |
|---|---|
| FDA product code | KCM |
| Device type | Dropper, Ent |
| Device class | Class 1 |
| Regulation | 21 CFR 874.5220 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K051157 |
| Record published | 2021-05-18 |
| Record revised | 2022-09-16 (version 10) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IN-7900-NF | In distribution | |
| IN-8633-AR | In distribution | |
| IN-7920-NF | In distribution | |
| IN-7780-R | In distribution | |
| IN-7910-NF | In distribution | |
| IN-7780-NF | In distribution | |
| IN-7940-NF | In distribution | |
| IN-7950-NF | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Apex | Drive DeVilbiss Healthcare | 8 |
| AutoSqueeze | Owen Mumford USA, Inc. | 2 |
| AutoDrop | Owen Mumford USA, Inc. | 2 |
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.