Hu-Friedy
Lead Free Blank Autoclave Monitor Tape
19manufacturers in China registered for this device type
32catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (7), Anhui (4), Hubei (3). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hubei Qianjiang Kingphar Medical Material Co., Ltd. | Qianjiang | Hubei | Contract manufacturer | 52 |
| Shanghai Jianzhong Medical Packaging Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 3 |
| Dongguan Safesecure Medical Packaging Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 2 |
| Jiangsu Jsongmed Medical Material Co., Ltd. | Jiangsu | Jiangsu | Contract manufacturer | 2 |
| Hubei Guarddent Medical Technology Co., Ltd. | Wuhan | Hubei | Manufacturer | 60 |
| Shanghai Hua En Industrial Co Ltd | Shanghai | Shanghai | Contract manufacturer | 52 |
| Anqing Clean Dental Instrument Technology Co., Ltd. | Anqing | Anhui | Manufacturer | 50 |
| Lakong Medical Devices Co., Ltd. | Dongguan | Guangdong | Remanufacturer | 39 |
| Wellmed Dental Medical Supply Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 37 |
| Premium Plus (Dongguan) Limited | Dongguan | Guangdong | Repacker / relabeller | 34 |
| Anhui Ares Medical Technology Co., Ltd. | Tianchang | Anhui | Contract manufacturer | 28 |
| Bgss Company Asia Limited | Zhabei | Shanghai | Contract manufacturer | 25 |
Showing 12 of 19. All 19 manufacturers in China registered for Indicator, Physical/Chemical Sterilization Process
Record
| Listed by | HU-Friedy MFG Co., LLC, United States |
|---|---|
| FDA product code | JOJ |
| Device type | Indicator, Physical/Chemical Sterilization Process |
| Device class | Class 2 |
| Regulation | 21 CFR 880.2800 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K171823 |
| Record published | 2016-09-21 |
| Record revised | 2025-02-21 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 60 to 85 °F |
| Distribution end date | 2023-06-26 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| IMS-1243 | In distribution | ||
| IMS-1241 | 100 | In distribution | |
| SP-INT | In distribution | ||
| IMS-1255 | In distribution | ||
| IMS-1266 | In distribution | ||
| IMS-1253 | In distribution | ||
| IMS-1461 | In distribution | ||
| IMS-1267 | In distribution | ||
| IMS-1259 | In distribution | ||
| IMS-1256 | In distribution | ||
| IMS-1252 | In distribution | ||
| IMS-1264 | In distribution | ||
| IMCO-INDNA | 250 | In distribution | |
| IMS-1258 | In distribution | ||
| IMS-1251 | In distribution | ||
| IMS-1262 | In distribution | ||
| IMS-1269 | In distribution | ||
| IMS-1260 | In distribution | ||
| IMS-1240 | 250 | In distribution | |
| IMS-1257 | In distribution | ||
| IMS-1263 | In distribution | ||
| IMS-1268 | In distribution | ||
| IMS-1248 | In distribution | ||
| IMS-1247 | In distribution | ||
| IMS-1265 | In distribution | ||
| IMS-1254 | In distribution | ||
| IMS-1244 | Withdrawn | ||
| IMS-1245 | Withdrawn | ||
| IMS-1246 | Withdrawn | ||
| IMS-1249 | Withdrawn | ||
| IMS-1460 | Withdrawn | ||
| IMS-1250 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| JMU | JMU Dental, Inc | 32 |
| MARK3 | Cargus International, Inc | 28 |
| Comply™ | 3M Company | 25 |
| Verify | Albert Browne Ltd. | 24 |
| Cardinal Health | Cardinal Health 200, LLC | 19 |
| Verify | Steris Corporation | 18 |
| McKesson | Mckesson Medical-Surgical Inc. | 16 |
| Sklar® | Sklar Corporation | 14 |
| Case Medical | Case Medical, Inc. | 13 |
| Dental City | ICP, Inc. | 13 |
| PlastCare | Proguard Health Inc. | 12 |
| PeelVue Pro | Kerr Corporation | 12 |
Showing 12 of 278. All products under Indicator, Physical/Chemical Sterilization Process
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.