Gibson Healthcare
Gibson Healthcare 3-4 is a regenerative collagen dental membrane used as an intraoral barrier in guided tissue or bone-regeneration procedures. The membrane can also act as a barrier to…
Gibson Healthcare 3-4 is a regenerative collagen dental membrane used as an intraoral barrier in guided tissue or bone-regeneration procedures. The membrane can also act as a barrier to help contain bone-graft material in the treated area. It serves as a temporary barrier in the regenerative site.
Membrane 3-4 is one listed example within the Gibson Healthcare range, which contains multiple size variants. The membrane is placed at the regenerative site as a physical barrier alongside the procedure’s other materials.
Listed Item
Gibson Healthcare Membrane 3-4 Regenerative Collagen Dental Membrane
Barrier Function
The collagen membrane separates the graft or regenerative area from surrounding oral tissue. In this placement, it functions as a physical barrier that supports the intended regenerative workflow.
The Membrane 3-4 listing is one example within Gibson Healthcare’s collagen membrane range. The exact variant and dimensions are model-specific.
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 | Benco Dental Supply Co. |
|---|---|
| FDA product code | NPL |
| Device type | Barrier, Animal Source, Intraoral |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3930 |
| Record published | 2018-06-04 |
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 |
| Storage | Storage environment temperature 15 to 30 °C |
| Sizes | Length 12 to 30 mm; width 16 to 40 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5303-351 | Length 15 mm | In distribution |
| 5250-784 | Width 20 mm | In distribution |
| 5250-855 | Width 30 mm | In distribution |
| 5250-944 | Length 15 mm | In distribution |
| 5250-908 | Width 16 mm | In distribution |
| 5250-953 | Width 40 mm | In distribution |
| 5303-226 | Length 15 mm | In distribution |
| 5303-306 | Length 15 mm | In distribution |
| 5250-935 | Width 30 mm | In distribution |
| 5303-235 | Length 20 mm | In distribution |
| 5303-299 | Length 30 mm | In distribution |
| 5303-342 | Length 30 mm | In distribution |
| 5250-891 | Length 15 mm | In distribution |
| 5303-324 | Length 20 mm | In distribution |
| 5250-917 | Width 16 mm | In distribution |
| 5250-926 | Width 20 mm | In distribution |
| 5303-388 | Length 15 mm | In distribution |
| 5250-864 | Width 40 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Neocirrus | NEO Modulus (Suzhou) Medical SCI-Tech Co., Ltd. | 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 |
| AmpliDerm | Collagen Matrix, Inc. | 7 |
Showing 12 of 132. All products under Barrier, Animal Source, Intraoral
Recalls Naming This Product
6 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Collagen Matrix, Inc. | UDI-DI | 2019-11-05 | Class II | Labeling mix-ups | The products may have been packaged with an incorrect Instructions for Use. | 192 total | 2020-08-03 |
| Collagen Matrix, Inc. | UDI-DI | 2019-11-05 | Class II | Labeling mix-ups | The products may have been packaged with an incorrect Instructions for Use. | 192 total | 2020-08-03 |
| Collagen Matrix, Inc. | UDI-DI | 2019-11-05 | Class II | Labeling mix-ups | The products may have been packaged with an incorrect Instructions for Use. | 192 total | 2020-08-03 |
| Collagen Matrix, Inc. | UDI-DI | 2019-11-05 | Class II | Labeling mix-ups | The products may have been packaged with an incorrect Instructions for Use. | 192 total | 2020-08-03 |
| Collagen Matrix, Inc. | UDI-DI | 2019-11-05 | Class II | Labeling mix-ups | The products may have been packaged with an incorrect Instructions for Use. | 192 total | 2020-08-03 |
| Collagen Matrix, Inc. | UDI-DI | 2019-11-05 | Class II | Labeling mix-ups | The products may have been packaged with an incorrect Instructions for Use. | 192 total | 2020-08-03 |
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.