Summit Medical
13 catalogue numbers from 10-3000-05KS, listed by Summit Medical LLC, United States, under Splint, Nasal. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
13catalogue numbers in this listing
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 | Summit Medical LLC, United States |
|---|---|
| FDA product code | EPP |
| Device type | Splint, Nasal |
| Device class | Class 1 |
| Regulation | 21 CFR 874.5800 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-11-20 |
| Record revised | 2021-08-23 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Carton of 10, box of 10, box of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10-3000-05KS | In distribution | |
| 10-3000-10NKP | In distribution | |
| 72-3021 | In distribution | |
| 72-3025 | In distribution | |
| 72-3026 | In distribution | |
| 10-3000-05KL | In distribution | |
| 10-3000-05KP | In distribution | |
| 10-3000-10NKL | In distribution | |
| 72-3027 | In distribution | |
| 10-3000-10NKS | In distribution | |
| 72-3022 | In distribution | |
| 10-3000-10NKM | In distribution | |
| 72-3020 | 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 |
| 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 |
| Thermasplint | Medtronic Xomed, Inc. | 6 |
Showing 12 of 45. All products under Splint, Nasal
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.