Ousia bioMAINTAIN
OUSIA bioMAINTAIN 30X40MM RESORBABLE DENTAL MEMBRANE 4-6 mo.
2manufacturers in China registered for this device type
9catalogue numbers in this listing
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 | Ace Surgical Supply Co., Inc., United States |
|---|---|
| FDA product code | NPL |
| Device type | Barrier, Animal Source, Intraoral |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3930 |
| Record published | 2015-10-24 |
| Record revised | 2018-03-29 (version 2) |
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 |
| Packaging | Tyvec bag of 25 |
| Sizes | Width 15 to 30 mm; length 20 to 40 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OUSA2 | Width 20 mm | In distribution |
| OUSA2S | Width 20 mm | In distribution |
| OUSA3EU | In distribution | |
| OUSA2EU | In distribution | |
| OUSA1EU | In distribution | |
| OUSA3 | Length 40 mm | In distribution |
| OUSA3S | Length 40 mm | In distribution |
| OUSA1 | Length 20 mm | In distribution |
| OUSA1S | Length 20 mm | In distribution |
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 |
| 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 |
| AmpliDerm | Collagen Matrix, Inc. | 7 |
Showing 12 of 132. All products under Barrier, Animal Source, Intraoral
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.