Gelita-Spon® Standard
The GELITA-SPON® Absorbable Gelatin Sponge, U.S.P. (“Gelita-Spon”) is made of 100% purified porcine gelatine and is of neutral character in nature. GELITA-SPON® Absorbable Gelatin Sponge is…
The GELITA-SPON® Absorbable Gelatin Sponge, U.S.P. (“Gelita-Spon”) is made of 100% purified porcine gelatine and is of neutral character in nature. GELITA-SPON® Absorbable Gelatin Sponge is non-pyrogenic. It is intended for use to control minimal bleeding by tamponade effect, blood absorption and platelet aggregation following ENT surgery. It is insoluble in water and fully absorbable. Its porous structure and interstices enables the product to absorb more than 35 times its own weight of blood and fluids. The absorptive capacity of GELITA-SPON® is a function of its physical size, increasing as the amount of gelatine increases. It is supplied in several sizes. It is packaged individually in (double) blister, pouch or jar/container packaging, sterilized by gamma rays, and is for single use only.
Who Else Makes It
Concentrated in Jiangsu (1), Shandong (1), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Bioregen Biomedical (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 2 |
| Neo Modulus (Shandong) Medical Sci-Tech Co., Ltd. | Weifang | Shandong | Manufacturer | 1 |
| Zhejiang Meihua Dingchang Pharmaceutical Co., Ltd. | Shaoxing | Zhejiang | Manufacturer | 1 |
Record
| Listed by | Gelita Medical Gmbh |
|---|---|
| FDA product code | LYA |
| Device type | Splint, Intranasal Septal |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4780 |
| Record published | 2021-07-27 |
| Record revised | 2023-12-14 (version 3) |
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, manufacturing date |
| Storage | Special storage condition: Store at room temperature, keep dry and away from sunlight |
| Packaging | Transport box of 12, suture box of 10, transport box of 4, suture box of 5, suture box of 20, suture box of 50 |
| Sizes | Length 10 to 200 mm; depth 10 to 80 mm; height 7 to 10 mm; outer diameter 30 mm; height 500 µm |
| Distribution end date | 2023-12-12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GS-060 | Length 60 mm | Withdrawn |
| GS-610 | Length 125 mm | Withdrawn |
| GS-030 | Length 80 mm | Withdrawn |
| GS-015 | Length 80 mm | Withdrawn |
| GS-210 | Length 80 mm | Withdrawn |
| GS-950 | Length 200 mm | Withdrawn |
| GS-325 | Length 10 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Netcell | Network Medical Products, Ltd. | 33 |
| Invotec Silicone Sheeting | Invotec International, Inc. | 20 |
| Septal splints | Spiggle & Theis Medizintechnik Gmbh | 20 |
| Velnez | Datt Mediproducts Private Limited | 20 |
| Husteon MeshNasal | Medifab Co., Ltd. | 20 |
| Husteon Nasal | Medifab Co., Ltd. | 18 |
| Rhino Rocket | Shippert Medical Technologies Corp. | 17 |
| Custom Cut Silicone Sheeting For Internal Nasal Splints & Packing | Invotec International, Inc. | 16 |
| Splint, Intranasal Septal | Shippert Medical Technologies Corp. | 16 |
| Exmoor | Exmoor Plastics Limited | 15 |
| Nasal Hemostasis Sponge | Neo Modulus (Shandong) Medical Sci-Tech Co., Ltd. | 14 |
| Orca Foam | Orca Products LLC | 13 |
Showing 12 of 94. All products under Splint, Intranasal Septal
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 |
|---|---|---|---|---|
| 2022-07-27 | Class II | Under Investigation by firm | In routine bioburden testing, higher than acceptable levels of Endotoxins were observed. | 3596 boxes of 50 devices |
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.