Thermasplint
Splint 1529010 10PK Thermasplint Medium
2manufacturers in China registered for this device type
6catalogue numbers in this listing
2recalls on this code
Who Else Makes It
Concentrated in Hong Kong (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Qibei Technology Co., Limited | Kl | Hong Kong | Manufacturer | 15 |
| Guangdong Meicen Medical Equipment Co., Ltd. | Foshan | Guangdong | Manufacturer | 7 |
Record
| Listed by | Medtronic Xomed, Inc., United States |
|---|---|
| FDA product code | EPP |
| Device type | Splint, Nasal |
| Device class | Class 1 |
| Regulation | 21 CFR 874.5800 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-04-19 |
| Record revised | 2021-03-04 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Length 3.2 to 4.4 cm; width 5.7 to 6.7 cm |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1529010 | 10 | In distribution | |
| 1529000 | Length 3.2 cm | 10 | In distribution |
| 1529010 | Width 6.0 cm | 10 | In distribution |
| 1529000 | 10 | In distribution | |
| 1529020 | 10 | In distribution | |
| 1529020 | Width 6.7 cm | 10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Aquaplast PS™ | Qfix | 82 |
| Denver Splint | Shippert Medical Technologies Corp. | 73 |
| Denver Splint | Summit Medical LLC | 67 |
| Splint, Nasal | Medtronic Xomed, Inc. | 33 |
| Splint, Nasal | Summit Medical LLC | 16 |
| Summit Medical | Summit Medical LLC | 13 |
| SurgiPlast Nasal Splint | Surgical Technology Laboratories Inc. | 12 |
| External thermoplastic nasal splint | Spiggle & Theis Medizintechnik Gmbh | 10 |
| Soft-Form™ ALD External Nasal Splint | Invotec International, Inc. | 8 |
| Splint, Nasal | Shippert Medical Technologies Corp. | 8 |
| External aluminium nasal splint | Spiggle & Theis Medizintechnik Gmbh | 7 |
| Soft-Form™ AL External Nasal Splint | Invotec International, Inc. | 6 |
Showing 12 of 45. All products under Splint, Nasal
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 |
|---|---|---|---|---|---|
| 2011-02-21 | Not classified | Material/Component Contamination | Medtronic Xomed, Inc. Jacksonville, FL issued a recall on Feb 21, 2011 for all lots of the alcohol pad packaged with the Medtronic’s External Nasal Splints REF 1528116 (sm), 1528126 (med), 1528136 (lg) and the Thermasplints REF 1529100 (sm) | 26,305 units (5,261 boxes) | 2012-04-03 |
| 2011-02-21 | Not classified | Material/Component Contamination | Medtronic Xomed, Inc. Jacksonville, FL issued a recall on Feb 21, 2011 for all lots of the alcohol pad packaged with the Medtronic’s External Nasal Splints REF 1528116 (sm), 1528126 (med), 1528136 (lg) and the Thermasplints REF 1529100 (sm) | 8,385 units (1,677 boxes) | 2012-04-03 |
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.