Sientra Nostril Retainer
Nostril Retainer w/Fixation, Solid Silicone, Smooth, 26 mm
3manufacturers in China registered for this device type
11catalogue numbers in this listing
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 | Sientra, Inc., United States |
|---|---|
| FDA product code | LYA |
| Device type | Splint, Intranasal Septal |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4780 |
| 510(k) | K980221 |
| Record published | 2015-10-23 |
| Record revised | 2023-10-25 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | expiry date, serial number |
| Sizes | Width 18 to 29 mm |
| Distribution end date | 2022-06-13 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1171-026U | Width 26 mm | Withdrawn |
| 1171-028U | Width 28 mm | Withdrawn |
| 1171-023U | Width 23 mm | Withdrawn |
| 1171-025U | Width 25 mm | Withdrawn |
| 1171-018U | Width 18 mm | Withdrawn |
| 1171-022U | Width 22 mm | Withdrawn |
| 1171-029U | Width 29 mm | Withdrawn |
| 1171-027U | Width 27 mm | Withdrawn |
| 1171-024U | Width 24 mm | Withdrawn |
| 1171-020U | Width 20 mm | Withdrawn |
| 1171-021U | Width 21 mm | Withdrawn |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
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.