Curity
Curity Non-adherent Strips
3manufacturers in China registered for this device type
6catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Guangdong (2), 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 |
|---|---|---|---|---|
| Derma Sciences Nantong Incorporation | Development | Jiangsu | Contract manufacturer | 19 |
| Huizhou Foryou Medical Devices Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 18 |
| Shenzhen JPY ION-Tech. Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 20 |
Record
| Listed by | Cardinal Health 200, LLC, United States |
|---|---|
| FDA product code | KMF |
| Device type | Bandage, Liquid |
| Device class | Class 1 |
| Regulation | 21 CFR 880.5090 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2023-10-25 |
| Record revised | 2024-05-08 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 6, box of 36, box of 12, box of 24, box of 50, case of 12 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 6115 | 3 | In distribution | |
| 6116 | In distribution | ||
| 6113 | In distribution | ||
| 6112 | In distribution | ||
| 6114 | In distribution | ||
| 6121 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| PolyMem | Ferris MFG. Corp. | 60 |
| 3M™ Cavilon™ | 3M Company | 54 |
| Kendall | Cardinal Health | 23 |
| Kendall | Cardinal Health 200, LLC | 15 |
| Curity | Cardinal Health | 11 |
| GluSeal® | Glustich Inc | 7 |
| Stratis | Covidien LP | 7 |
| Tritis | Covidien LP | 4 |
| GluSeal®90 | Glustich Inc | 3 |
| Medline | Medline Industries, Inc. | 3 |
| GluSeal®90 | Skinstitch Corp. | 2 |
| Medline Industries, Inc. | Medline Industries, Inc. | 2 |
Showing 12 of 29. All products under Bandage, Liquid
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2020-01-15 | Class II | Under Investigation by firm | Non-sterile product was shipped to customers. Product package is labeled as both “STERILE” and “NON-STERILR” ; the product did not undergo sterilization process and is non-sterile. The usage of a needle that is not sterile could result in | 8400 each | 2020-12-04 |
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.