Neodent
GM Easyguide Surgical KIT Case Narrow/Regular Diam Implants
5manufacturers in China registered for this device type
48catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (2), Shandong (1), Guangdong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Lianyungang Anson Non-woven Product Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 13 |
| Medipack Medical Packaging MFG. Co. | Dongguan | Guangdong | Contract manufacturer | 5 |
| AR Medicom Inc., (Asia), Ltd. | Hongkong | Hong Kong | Exporter | 5 |
| Wipak Packaging (Changshu) Co., Ltd. | Changshu | Jiangsu | Manufacturer | 2 |
Record
| Listed by | Jjgc Indústria e Comércio de Materiais Dentários S.A., Brazil |
|---|---|
| FDA product code | KCT |
| Device type | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6850 |
| 510(k) | K171713 |
| Record published | 2023-08-10 |
| Record revised | 2024-01-03 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Special storage condition: Keep away from sunlight; Special storage condition: keep dry |
| Sizes | Length 195 to 264 mm; width 90 to 163 mm; height 44 to 67 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 110.270 | In distribution | |
| 110.301 | In distribution | |
| 110.343 | Height 64 mm | In distribution |
| 110.342 | Length 195 mm | In distribution |
| 110.269 | In distribution | |
| 110.300 | Length 195 mm | In distribution |
| 110.336 | Width 90 mm | In distribution |
| 110315 | Length 195 mm | In distribution |
| 110.277 | In distribution | |
| 110.293 | In distribution | |
| 110.288 | Length 264 mm | In distribution |
| 110.265 | In distribution | |
| 110.297 | Length 195 mm | In distribution |
| 110.287 | Width 163 mm | In distribution |
| 110.284 | In distribution | |
| 110.344 | Length 195 mm | In distribution |
| 110.307 | In distribution | |
| 110.294 | Width 90 mm | In distribution |
| 110.335 | In distribution | |
| 110.308 | In distribution | |
| 110316 | Length 195 mm | In distribution |
| 110.346 | Height 67 mm | In distribution |
| 110314 | Length 195 mm | In distribution |
| 110.268 | In distribution | |
| 110.286 | In distribution | |
| 110.285 | In distribution | |
| 110.303 | Length 195 mm | In distribution |
| 110.263 | In distribution | |
| 110.306 | In distribution | |
| 110.266 | In distribution | |
| 110.302 | Length 264 mm | In distribution |
| 110.318 | In distribution | |
| 110.304 | Length 195 mm | In distribution |
| 110.341 | Height 64 mm | In distribution |
| 110.340 | Height 64 mm | In distribution |
| 110.283 | In distribution | |
| 110.317 | In distribution | |
| 110.299 | Length 264 mm | In distribution |
| 110.296 | Height 58 mm | In distribution |
| 110313 | Length 195 mm | In distribution |
| 110.262 | In distribution | |
| 110.295 | Width 90 mm | In distribution |
| 110321 | Length 264 mm | In distribution |
| 110.337 | Height 49 mm | In distribution |
| 110.305 | Length 195 mm | In distribution |
| 110.278 | In distribution | |
| 110.345 | Height 67 mm | In distribution |
| 110.267 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Instrusafe | Summit Medical LLC | 6,357 |
| V. Mueller | Steris Corporation | 1,080 |
| Ermis | Ermis MedTech | 597 |
| Bahadir USA | Bahadir USA LLC | 561 |
| Avalign | Avalign Technologies, Inc. | 447 |
| Sklar® | Sklar Corporation | 363 |
| HNM Medical | HNM Stainless, LLC. | 337 |
| Surgical Instrument | SIN Sistema DE Implante Nacional S.A | 295 |
| ReLine | Nuvasive, Inc. | 290 |
| Case Medical | Case Medical, Inc. | 289 |
| Millennium | Avalign Technologies, Inc. | 268 |
| V. Mueller | Carefusion 2200, Inc. | 174 |
Showing 12 of 599. All products under Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K241492 | 2024-08-23 |
| K230804 | 2023-07-07 |
| K214051 | 2022-04-13 |
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.