OptiMatrix™ Extracellular Matrix
3 catalogue numbers from 30053-03, listed by DSM Biomedical, Inc., United States, under Barrier, Animal Source, Intraoral. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
3catalogue numbers in this listing
3recalls on this code
Who Else Makes It
Concentrated in Beijing (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beijing Biosis Healing Biological Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
| NEO Modulus (Suzhou) Medical SCI-Tech Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 1 |
Record
| Listed by | DSM Biomedical, Inc., United States |
|---|---|
| FDA product code | NPL |
| Device type | Barrier, Animal Source, Intraoral |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3930 |
| Establishment | Contract manufacturer, Manufacturer |
| Record published | 2015-09-17 |
| Record revised | 2023-06-20 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Length 20 to 40 mm; width 15 to 30 mm |
| Distribution end date | 2019-09-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 30053-03 | Length 40 mm | Withdrawn |
| 30053-01 | Length 20 mm | Withdrawn |
| 30053-02 | Length 30 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Neocirrus | NEO Modulus (Suzhou) Medical SCI-Tech Co., Ltd. | 18 |
| Gibson Healthcare | Benco Dental Supply Co. | 18 |
| Endoform™ Dental Membrane | Aroa Biosurgery Ltd | 12 |
| Ousia bioADAPT | Ace Surgical Supply Co., Inc. | 9 |
| GuidOss | Nibec Co Ltd | 9 |
| RCM6 Resorbable Collagen Membrane | Ace Surgical Supply Co., Inc. | 9 |
| Ousia bioMAINTAIN | Ace Surgical Supply Co., Inc. | 9 |
| Genoss Collagen Membrane | Genoss Co., Ltd. | 9 |
| bioMAINTAIN | Collagen Matrix, Inc. | 9 |
| Salvin Dental Specialties | Salvin Dental Specialties, LLC | 8 |
| THE Cover | Purgo Biologics Inc. | 8 |
| PerioMatrix | Collagen Matrix, Inc. | 7 |
Showing 12 of 132. All products under Barrier, Animal Source, Intraoral
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2012-02-28 | Not classified | Employee error | Recall has been initiated due to concerns regarding the sterility of the product. The firm initiated the recall because of use of inadequately sterilized product might result in patient infection, | Total all sizes – 6387 units; p/n 20650-02 – 1487 units | 2013-04-11 |
| 2012-02-28 | Not classified | Employee error | Recall has been initiated due to concerns regarding the sterility of the product. The firm initiated the recall because of use of inadequately sterilized product might result in patient infection, | Total all sizes: 6387 units; p/n 20650-01 – 1487 units | 2013-04-11 |
| 2012-02-28 | Not classified | Employee error | Recall has been initiated due to concerns regarding the sterility of the product. The firm initiated the recall because of use of inadequately sterilized product might result in patient infection, | total all sizes: 6387 units; p/n 20650-03 – 765 units | 2013-04-11 |
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.